German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Clinical_Study - XML Profile

XML representation of the clinical-study resource profile.

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<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="clinical-study"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy">ResearchStudy</a><a name="ResearchStudy"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/researchstudy.html">ResearchStudy</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier">Slices for identifier</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="opacity: 0.5; font-style: italic">0</span><span style="opacity: 0.5; font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Business Identifier for study</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern:$this</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:eudraCT" title="Slice eudraCT">identifier:eudraCT</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Eudra CT Number<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">https://www.clinicaltrialsregister.eu</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:eudraCT.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">https://www.clinicaltrialsregister.eu</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:eudraCT.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:NCT" title="Slice NCT">identifier:NCT</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">NCT number<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://clinicaltrials.gov</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:NCT.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://clinicaltrials.gov</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:NCT.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:PMID" title="Slice PMID">identifier:PMID</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pubmed ID<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://www.ncbi.nlm.nih.gov/pubmed</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:PMID.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://www.ncbi.nlm.nih.gov/pubmed</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:PMID.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DOI" title="Slice DOI">identifier:DOI</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Digital Object Identifier<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">https://doi.org</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DOI.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">https://doi.org</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DOI.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:URI" title="Slice URI">identifier:URI</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Uniform Resource Identifier<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">urn:ietf:rfc:3986</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:URI.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">urn:ietf:rfc:3986</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:URI.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DRKS" title="Slice DRKS">identifier:DRKS</a><a name="ResearchStudy.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Deusches Register Klinischer Studien<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Identifier.system">system</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The namespace for the identifier value<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">https://www.drks.de</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DRKS.system">system</a><a name="ResearchStudy.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">https://www.drks.de</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.identifier:DRKS.value">value</a><a name="ResearchStudy.identifier.value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The value that is unique</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.title">title</a><a name="ResearchStudy.title"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name for this study</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.status">status</a><a name="ResearchStudy.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.primaryPurposeType">primaryPurposeType</a><a name="ResearchStudy.primaryPurposeType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.phase">phase</a><a name="ResearchStudy.phase"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4</span><br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/R4/valueset-research-study-phase.html">ResearchStudyPhase</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.category">Slices for category</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Classifications for the study</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern:$this</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.category:studyCategory" title="Slice studyCategory">category:studyCategory</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classifications for the study</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-studienkategorien-ncit.html">ValueSet Studienkategorien NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.category:studyDesign" title="Slice studyDesign">category:studyDesign</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classifications for the study</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-studiendesign-ncit.html">ValueSet Studiendesign NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.category:typeOfBlinding" title="Slice typeOfBlinding">category:typeOfBlinding</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classifications for the study</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-type-of-blinding-ncit.html">ValueSet Type of Blinding NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.category:typeOfRandomization" title="Slice typeOfRandomization">category:typeOfRandomization</a><a name="ResearchStudy.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Classifications for the study</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-type-of-randomization-ncit.html">ValueSet Type of Randomization NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.focus">focus</a><a name="ResearchStudy.focus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Drugs, devices, etc. under study</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-study-focus-ncit.html">ValueSet Study Focus NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.arm">arm</a><a name="ResearchStudy.arm"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Defined path through the study for a subject</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-clinical-study-definitions.html#ResearchStudy.arm.type">type</a><a name="ResearchStudy.arm.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Categorization of study arm</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-type-of-study-arm-ncit.html">ValueSet Type of Study Arm NCIt</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
  <url
       value="https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study"/>
  <version value="0.1.0"/>
  <name value="Clinical_Study"/>
  <title value="Profile Clinical Study"/>
  <status value="draft"/>
  <date value="2023-12-13T13:28:13+00:00"/>
  <publisher value="Berlin Institute of Health at Charité (BIH)"/>
  <contact>
    <name value="Berlin Institute of Health at Charité (BIH)"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.bihealth.org/"/>
    </telecom>
  </contact>
  <description
               value="Profile to describe a clinical study in which a patient takes part."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="DEU"/>
    </coding>
  </jurisdiction>
  <copyright value="CC-BY-SA-4.0"/>
  <fhirVersion value="4.0.1"/>
  <mapping>
    <identity value="BRIDG5.1"/>
    <uri value="https://bridgmodel.nci.nih.gov"/>
    <name value="BRIDG 5.1 Mapping"/>
  </mapping>
  <mapping>
    <identity value="v2"/>
    <uri value="http://hl7.org/v2"/>
    <name value="HL7 v2 Mapping"/>
  </mapping>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <mapping>
    <identity value="clinicaltrials-gov"/>
    <uri value="http://clinicaltrials.gov"/>
    <name value="ClinicalTrials.gov Mapping"/>
  </mapping>
  <mapping>
    <identity value="w5"/>
    <uri value="http://hl7.org/fhir/fivews"/>
    <name value="FiveWs Pattern Mapping"/>
  </mapping>
  <kind value="resource"/>
  <abstract value="false"/>
  <type value="ResearchStudy"/>
  <baseDefinition
                  value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
  <derivation value="constraint"/>
  <snapshot>
    <element id="ResearchStudy">
      <path value="ResearchStudy"/>
      <short
             value="Investigation to increase healthcare-related patient-independent knowledge"/>
      <definition
                  value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.  This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques.  A ResearchStudy involves the gathering of information about human or animal subjects."/>
      <comment value="Need to make sure we encompass public health studies."/>
      <alias value="Clinical Trial"/>
      <alias value="Study"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="dom-2"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
        <expression value="contained.contained.empty()"/>
        <xpath value="not(parent::f:contained and f:contained)"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-3"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
        <expression
                    value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
        <xpath
               value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-4"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
        <expression
                    value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
        <xpath
               value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-5"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
        <expression value="contained.meta.security.empty()"/>
        <xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
          <valueBoolean value="true"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
          <valueMarkdown
                         value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
        </extension>
        <key value="dom-6"/>
        <severity value="warning"/>
        <human
               value="A resource should have narrative for robust management"/>
        <expression value="text.`div`.exists()"/>
        <xpath value="exists(f:text/h:div)"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Entity. Role, or Act"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="OBX"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.id">
      <path value="ResearchStudy.id"/>
      <short value="Logical id of this artifact"/>
      <definition
                  value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
      <comment
               value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.meta">
      <path value="ResearchStudy.meta"/>
      <short value="Metadata about the resource"/>
      <definition
                  value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.meta"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Meta"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.implicitRules">
      <path value="ResearchStudy.implicitRules"/>
      <short value="A set of rules under which this content was created"/>
      <definition
                  value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
      <comment
               value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.implicitRules"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.language">
      <path value="ResearchStudy.language"/>
      <short value="Language of the resource content"/>
      <definition
                  value="The base language in which the resource is written."/>
      <comment
               value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.language"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
          <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/>
        </extension>
        <strength value="preferred"/>
        <description value="A human language."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
      </binding>
    </element>
    <element id="ResearchStudy.text">
      <path value="ResearchStudy.text"/>
      <short value="Text summary of the resource, for human interpretation"/>
      <definition
                  value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment
               value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Act.text?"/>
      </mapping>
    </element>
    <element id="ResearchStudy.contained">
      <path value="ResearchStudy.contained"/>
      <short value="Contained, inline Resources"/>
      <definition
                  value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
      <comment
               value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
      <alias value="inline resources"/>
      <alias value="anonymous resources"/>
      <alias value="contained resources"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.contained"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Resource"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.extension">
      <path value="ResearchStudy.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.modifierExtension">
      <path value="ResearchStudy.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier"/>
      <slicing>
        <discriminator>
          <type value="pattern"/>
          <path value="$this"/>
        </discriminator>
        <rules value="open"/>
      </slicing>
      <short value="Business Identifier for study"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="eudraCT"/>
      <short value="Eudra CT Number"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="https://www.clinicaltrialsregister.eu"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="https://www.clinicaltrialsregister.eu"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="NCT"/>
      <short value="NCT number"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="http://clinicaltrials.gov"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="http://clinicaltrials.gov"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:NCT.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="PMID"/>
      <short value="Pubmed ID"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="http://www.ncbi.nlm.nih.gov/pubmed"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="http://www.ncbi.nlm.nih.gov/pubmed"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:PMID.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="DOI"/>
      <short value="Digital Object Identifier"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="https://doi.org"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="https://doi.org"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DOI.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="URI"/>
      <short value="Uniform Resource Identifier"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="urn:ietf:rfc:3986"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="urn:ietf:rfc:3986"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:URI.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="DRKS"/>
      <short value="Deusches Register Klinischer Studien"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <patternIdentifier>
        <system value="https://www.drks.de"/>
      </patternIdentifier>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.id">
      <path value="ResearchStudy.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.extension">
      <path value="ResearchStudy.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.use">
      <path value="ResearchStudy.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment
               value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements
                    value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.type">
      <path value="ResearchStudy.identifier.type"/>
      <short value="Description of identifier"/>
      <definition
                  value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment
               value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements
                    value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.system">
      <path value="ResearchStudy.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition
                  value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements
                    value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <patternUri value="https://www.drks.de"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.value">
      <path value="ResearchStudy.identifier.value"/>
      <short value="The value that is unique"/>
      <definition
                  value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment
               value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.period">
      <path value="ResearchStudy.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition
                  value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier:DRKS.assigner">
      <path value="ResearchStudy.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment
               value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title"/>
      <short value="Name for this study"/>
      <definition
                  value="A short, descriptive user-friendly label for the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.title"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Brief Title"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/>
      </mapping>
    </element>
    <element id="ResearchStudy.protocol">
      <path value="ResearchStudy.protocol"/>
      <short value="Steps followed in executing study"/>
      <definition
                  value="The set of steps expected to be performed as part of the execution of the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.protocol"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Interventions; Arm/Intervention Cross-Reference"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocumentVersionPublicTitle.name"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".outboundRelationship[typeCode=DEFN].target"/>
      </mapping>
    </element>
    <element id="ResearchStudy.partOf">
      <path value="ResearchStudy.partOf"/>
      <short value="Part of larger study"/>
      <definition
                  value="A larger research study of which this particular study is a component or step."/>
      <requirements
                    value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/>
      <alias value="container"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.partOf"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="CompanionStudyRelationship"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status"/>
      <short
             value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn"/>
      <definition value="The current state of the study."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.status"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyStatus"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Codes that convey the current status of the research study."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"/>
      </binding>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.status"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyOverallStatus.code"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".status"/>
      </mapping>
    </element>
    <element id="ResearchStudy.primaryPurposeType">
      <path value="ResearchStudy.primaryPurposeType"/>
      <short
             value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/>
      <definition
                  value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.primaryPurposeType"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPrimaryPurposeType"/>
        </extension>
        <strength value="extensible"/>
        <description value="Codes for the main intent of the study."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.primaryPurposeTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.phase">
      <path value="ResearchStudy.phase"/>
      <short
             value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/>
      <definition
                  value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.phase"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Study Phase"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.phaseCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category">
      <path value="ResearchStudy.category"/>
      <slicing>
        <discriminator>
          <type value="pattern"/>
          <path value="$this"/>
        </discriminator>
        <rules value="open"/>
      </slicing>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyCategory"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational, blinding type, etc."/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category:studyCategory">
      <path value="ResearchStudy.category"/>
      <sliceName value="studyCategory"/>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/studienkategorien-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category:studyDesign">
      <path value="ResearchStudy.category"/>
      <sliceName value="studyDesign"/>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/studiendesign-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category:typeOfBlinding">
      <path value="ResearchStudy.category"/>
      <sliceName value="typeOfBlinding"/>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-blinding-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category:typeOfRandomization">
      <path value="ResearchStudy.category"/>
      <sliceName value="typeOfRandomization"/>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-randomization-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus"/>
      <short value="Drugs, devices, etc. under study"/>
      <definition
                  value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.focus"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/study-focus-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Focus of Study"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="InterventionalStudyProtocol.interventionTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.condition">
      <path value="ResearchStudy.condition"/>
      <short value="Condition being studied"/>
      <definition
                  value="The condition that is the focus of the study.  For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;, but the target condition code would be a Lupus SNOMED code."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.condition"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ConditionCode"/>
        </extension>
        <strength value="example"/>
        <description value="Identification of the condition or diagnosis."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Conditions"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyCondition.code"/>
      </mapping>
    </element>
    <element id="ResearchStudy.contact">
      <path value="ResearchStudy.contact"/>
      <short value="Contact details for the study"/>
      <definition
                  value="Contact details to assist a user in learning more about or engaging with the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.contact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="ContactDetail"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact &amp; Backup (if Study tied to only one location); Investigators"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="PointOfContact &gt; Project &gt; Research Project &gt; Study &gt; StudyProtocol &gt; StudyProtocolVersion"/>
      </mapping>
    </element>
    <element id="ResearchStudy.relatedArtifact">
      <path value="ResearchStudy.relatedArtifact"/>
      <short value="References and dependencies"/>
      <definition value="Citations, references and other related documents."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.relatedArtifact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Citations, Links, Available Study Data/Documents"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/>
      </mapping>
    </element>
    <element id="ResearchStudy.keyword">
      <path value="ResearchStudy.keyword"/>
      <short value="Used to search for the study"/>
      <definition
                  value="Key terms to aid in searching for or filtering the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.keyword"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyKeyword"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Words associated with the study that may be useful in discovery."/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Keywords"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/>
      </mapping>
    </element>
    <element id="ResearchStudy.location">
      <path value="ResearchStudy.location"/>
      <short value="Geographic region(s) for study"/>
      <definition
                  value="Indicates a country, state or other region where the study is taking place."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.location"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Jurisdiction"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="Countries and regions within which this artifact is targeted for use."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.participatingLocationCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.description">
      <path value="ResearchStudy.description"/>
      <short value="What this is study doing"/>
      <definition
                  value="A full description of how the study is being conducted."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.description"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Detailed Description"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocumentVersion.publicDescription"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment">
      <path value="ResearchStudy.enrollment"/>
      <short value="Inclusion &amp; exclusion criteria"/>
      <definition
                  value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. &quot; 200 female Europeans between the ages of 20 and 45 with early onset diabetes&quot;."/>
      <comment
               value="The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource."/>
      <alias value="patient"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.enrollment"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".participation[typeCode=SBJ].role"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject"/>
      </mapping>
    </element>
    <element id="ResearchStudy.period">
      <path value="ResearchStudy.period"/>
      <short value="When the study began and ended"/>
      <definition
                  value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/>
      <alias value="timing"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Study Start Date (start); Study Completion Date (end)"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.done[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".effectiveTime"/>
      </mapping>
    </element>
    <element id="ResearchStudy.sponsor">
      <path value="ResearchStudy.sponsor"/>
      <short
             value="Organization that initiates and is legally responsible for the study"/>
      <definition
                  value="An organization that initiates the investigation and is legally responsible for the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.sponsor"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Sponsor"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.actor"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.principalInvestigator">
      <path value="ResearchStudy.principalInvestigator"/>
      <short value="Researcher who oversees multiple aspects of the study"/>
      <definition
                  value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.principalInvestigator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Principal Investigator"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.actor"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyInvestigator"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site">
      <path value="ResearchStudy.site"/>
      <short value="Facility where study activities are conducted"/>
      <definition
                  value="A facility in which study activities are conducted."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.site"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Location"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Facility"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.where[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="PlannedStudySite; StudySite"/>
      </mapping>
    </element>
    <element id="ResearchStudy.reasonStopped">
      <path value="ResearchStudy.reasonStopped"/>
      <short
             value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design"/>
      <definition
                  value="A description and/or code explaining the premature termination of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.reasonStopped"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyReasonStopped"/>
        </extension>
        <strength value="example"/>
        <description value="Codes for why the study ended prematurely."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Why Study Stopped"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.why[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyOverallStatus.studyStoppedReasonCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.note">
      <path value="ResearchStudy.note"/>
      <short value="Comments made about the study"/>
      <definition
                  value="Comments made about the study by the performer, subject or other participants."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.note"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Annotation"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="No BRIDG mapping"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm">
      <path value="ResearchStudy.arm"/>
      <short value="Defined path through the study for a subject"/>
      <definition
                  value="Describes an expected sequence of events for one of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.arm"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arms"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.id">
      <path value="ResearchStudy.arm.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.extension">
      <path value="ResearchStudy.arm.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.modifierExtension">
      <path value="ResearchStudy.arm.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.name">
      <path value="ResearchStudy.arm.name"/>
      <short value="Label for study arm"/>
      <definition
                  value="Unique, human-readable label for this arm of the study."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.name"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Label"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.name"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.type">
      <path value="ResearchStudy.arm.type"/>
      <short value="Categorization of study arm"/>
      <definition
                  value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-study-arm-ncit"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Type"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.typeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.description">
      <path value="ResearchStudy.arm.description"/>
      <short value="Short explanation of study path"/>
      <definition
                  value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.description"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Description"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.description"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective">
      <path value="ResearchStudy.objective"/>
      <short value="A goal for the study"/>
      <definition
                  value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.objective"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyObjective"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.id">
      <path value="ResearchStudy.objective.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.extension">
      <path value="ResearchStudy.objective.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.modifierExtension">
      <path value="ResearchStudy.objective.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.name">
      <path value="ResearchStudy.objective.name"/>
      <short value="Label for the objective"/>
      <definition
                  value="Unique, human-readable label for this objective of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.objective.name"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (BRIDG has a description, but not a name)"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.type">
      <path value="ResearchStudy.objective.type"/>
      <short value="primary | secondary | exploratory"/>
      <definition value="The kind of study objective."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.objective.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/>
        </extension>
        <strength value="preferred"/>
        <description value="Codes for the kind of study objective."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyObjective.typeCode"/>
      </mapping>
    </element>
  </snapshot>
  <differential>
    <element id="ResearchStudy">
      <path value="ResearchStudy"/>
    </element>
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier"/>
      <slicing>
        <discriminator>
          <type value="pattern"/>
          <path value="$this"/>
        </discriminator>
        <rules value="open"/>
      </slicing>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:eudraCT">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="eudraCT"/>
      <short value="Eudra CT Number"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="https://www.clinicaltrialsregister.eu"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="https://www.clinicaltrialsregister.eu"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:eudraCT.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:NCT">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="NCT"/>
      <short value="NCT number"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="http://clinicaltrials.gov"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:NCT.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="http://clinicaltrials.gov"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:NCT.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:PMID">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="PMID"/>
      <short value="Pubmed ID"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="http://www.ncbi.nlm.nih.gov/pubmed"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:PMID.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="http://www.ncbi.nlm.nih.gov/pubmed"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:PMID.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:DOI">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="DOI"/>
      <short value="Digital Object Identifier"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="https://doi.org"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:DOI.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="https://doi.org"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:DOI.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:URI">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="URI"/>
      <short value="Uniform Resource Identifier"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="urn:ietf:rfc:3986"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:URI.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="urn:ietf:rfc:3986"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:URI.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:DRKS">
      <path value="ResearchStudy.identifier"/>
      <sliceName value="DRKS"/>
      <short value="Deusches Register Klinischer Studien"/>
      <min value="0"/>
      <max value="1"/>
      <patternIdentifier>
        <system value="https://www.drks.de"/>
      </patternIdentifier>
    </element>
    <element id="ResearchStudy.identifier:DRKS.system">
      <path value="ResearchStudy.identifier.system"/>
      <min value="1"/>
      <patternUri value="https://www.drks.de"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.identifier:DRKS.value">
      <path value="ResearchStudy.identifier.value"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.primaryPurposeType">
      <path value="ResearchStudy.primaryPurposeType"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.phase">
      <path value="ResearchStudy.phase"/>
      <min value="1"/>
      <binding>
        <strength value="required"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/>
      </binding>
    </element>
    <element id="ResearchStudy.category">
      <path value="ResearchStudy.category"/>
      <slicing>
        <discriminator>
          <type value="pattern"/>
          <path value="$this"/>
        </discriminator>
        <rules value="open"/>
      </slicing>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.category:studyCategory">
      <path value="ResearchStudy.category"/>
      <sliceName value="studyCategory"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/studienkategorien-ncit"/>
      </binding>
    </element>
    <element id="ResearchStudy.category:studyDesign">
      <path value="ResearchStudy.category"/>
      <sliceName value="studyDesign"/>
      <min value="0"/>
      <max value="*"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/studiendesign-ncit"/>
      </binding>
    </element>
    <element id="ResearchStudy.category:typeOfBlinding">
      <path value="ResearchStudy.category"/>
      <sliceName value="typeOfBlinding"/>
      <min value="0"/>
      <max value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-blinding-ncit"/>
      </binding>
    </element>
    <element id="ResearchStudy.category:typeOfRandomization">
      <path value="ResearchStudy.category"/>
      <sliceName value="typeOfRandomization"/>
      <min value="0"/>
      <max value="1"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-randomization-ncit"/>
      </binding>
    </element>
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/study-focus-ncit"/>
      </binding>
    </element>
    <element id="ResearchStudy.arm">
      <path value="ResearchStudy.arm"/>
      <mustSupport value="true"/>
    </element>
    <element id="ResearchStudy.arm.type">
      <path value="ResearchStudy.arm.type"/>
      <mustSupport value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="https://www.vision-zero-oncology.de/fhir/ValueSet/type-of-study-arm-ncit"/>
      </binding>
    </element>
  </differential>
</StructureDefinition>