German Oncological Data Standard (GOLD)
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Resource Profile: Clinical_Study - Detailed Descriptions

Draft as of 2023-12-13

Definitions for the clinical-study resource profile.

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
2. ResearchStudy.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Must Supporttrue
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
4. ResearchStudy.identifier:eudraCT
Slice NameeudraCT
ShortEudra CT Number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.clinicaltrialsregister.eu&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
6. ResearchStudy.identifier:eudraCT.system
Control1..?
Must Supporttrue
Pattern Valuehttps://www.clinicaltrialsregister.eu
8. ResearchStudy.identifier:eudraCT.value
Control1..?
Must Supporttrue
10. ResearchStudy.identifier:NCT
Slice NameNCT
ShortNCT number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://clinicaltrials.gov&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
12. ResearchStudy.identifier:NCT.system
Control1..?
Must Supporttrue
Pattern Valuehttp://clinicaltrials.gov
14. ResearchStudy.identifier:NCT.value
Control1..?
Must Supporttrue
16. ResearchStudy.identifier:PMID
Slice NamePMID
ShortPubmed ID
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://www.ncbi.nlm.nih.gov/pubmed&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
18. ResearchStudy.identifier:PMID.system
Control1..?
Must Supporttrue
Pattern Valuehttp://www.ncbi.nlm.nih.gov/pubmed
20. ResearchStudy.identifier:PMID.value
Control1..?
Must Supporttrue
22. ResearchStudy.identifier:DOI
Slice NameDOI
ShortDigital Object Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://doi.org&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
24. ResearchStudy.identifier:DOI.system
Control1..?
Must Supporttrue
Pattern Valuehttps://doi.org
26. ResearchStudy.identifier:DOI.value
Control1..?
Must Supporttrue
28. ResearchStudy.identifier:URI
Slice NameURI
ShortUniform Resource Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;urn:ietf:rfc:3986&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
30. ResearchStudy.identifier:URI.system
Control1..?
Must Supporttrue
Pattern Valueurn:ietf:rfc:3986
32. ResearchStudy.identifier:URI.value
Control1..?
Must Supporttrue
34. ResearchStudy.identifier:DRKS
Slice NameDRKS
ShortDeusches Register Klinischer Studien
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.drks.de&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
36. ResearchStudy.identifier:DRKS.system
Control1..?
Must Supporttrue
Pattern Valuehttps://www.drks.de
38. ResearchStudy.identifier:DRKS.value
Control1..?
Must Supporttrue
40. ResearchStudy.title
Must Supporttrue
42. ResearchStudy.status
Must Supporttrue
44. ResearchStudy.primaryPurposeType
Must Supporttrue
46. ResearchStudy.phase
Control1..?
BindingThe codes SHALL be taken from ResearchStudyPhase
48. ResearchStudy.category
Control1..?
Must Supporttrue
SlicingThis element introduces a set of slices on ResearchStudy.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
50. ResearchStudy.category:studyCategory
Slice NamestudyCategory
Control1..1
BindingThe codes SHALL be taken from ValueSet Studienkategorien NCIt
Must Supporttrue
52. ResearchStudy.category:studyDesign
Slice NamestudyDesign
Control0..*
BindingThe codes SHALL be taken from ValueSet Studiendesign NCIt
Must Supporttrue
54. ResearchStudy.category:typeOfBlinding
Slice NametypeOfBlinding
Control0..1
BindingThe codes SHALL be taken from ValueSet Type of Blinding NCIt
Must Supporttrue
56. ResearchStudy.category:typeOfRandomization
Slice NametypeOfRandomization
Control0..1
BindingThe codes SHALL be taken from ValueSet Type of Randomization NCIt
Must Supporttrue
58. ResearchStudy.focus
BindingUnless not suitable, these codes SHALL be taken from ValueSet Study Focus NCIt
Must Supporttrue
60. ResearchStudy.arm
Must Supporttrue
62. ResearchStudy.arm.type
BindingThe codes SHALL be taken from ValueSet Type of Study Arm NCIt
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
Definition

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.

ShortInvestigation to increase healthcare-related patient-independent knowledge
Comments

Need to make sure we encompass public health studies.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesClinical Trial, Study
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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 (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())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ResearchStudy.implicitRules
Definition

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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ResearchStudy.modifierExtension
Definition

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).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. ResearchStudy.identifier
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
8. ResearchStudy.identifier:eudraCT
Slice NameeudraCT
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortEudra CT NumberBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.clinicaltrialsregister.eu&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchStudy.identifier:eudraCT.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ResearchStudy.identifier:eudraCT.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://www.clinicaltrialsregister.eu
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. ResearchStudy.identifier:eudraCT.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ResearchStudy.identifier:NCT
Slice NameNCT
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortNCT numberBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://clinicaltrials.gov&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ResearchStudy.identifier:NCT.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ResearchStudy.identifier:NCT.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttp://clinicaltrials.gov
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ResearchStudy.identifier:NCT.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ResearchStudy.identifier:PMID
Slice NamePMID
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortPubmed IDBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://www.ncbi.nlm.nih.gov/pubmed&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. ResearchStudy.identifier:PMID.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ResearchStudy.identifier:PMID.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttp://www.ncbi.nlm.nih.gov/pubmed
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. ResearchStudy.identifier:PMID.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. ResearchStudy.identifier:DOI
Slice NameDOI
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortDigital Object IdentifierBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://doi.org&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ResearchStudy.identifier:DOI.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ResearchStudy.identifier:DOI.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://doi.org
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ResearchStudy.identifier:DOI.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ResearchStudy.identifier:URI
Slice NameURI
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortUniform Resource IdentifierBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;urn:ietf:rfc:3986&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. ResearchStudy.identifier:URI.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. ResearchStudy.identifier:URI.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valueurn:ietf:rfc:3986
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ResearchStudy.identifier:URI.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ResearchStudy.identifier:DRKS
Slice NameDRKS
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortDeusches Register Klinischer StudienBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.drks.de&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ResearchStudy.identifier:DRKS.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. ResearchStudy.identifier:DRKS.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://www.drks.de
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ResearchStudy.identifier:DRKS.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. ResearchStudy.title
Definition

A short, descriptive user-friendly label for the study.

ShortName for this study
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ResearchStudy.status
Definition

The current state of the study.

Shortactive | 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
Control1..1
BindingThe codes SHALL be taken from ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1

Codes that convey the current status of the research study.

Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. ResearchStudy.primaryPurposeType
Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Shorttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Control0..1
BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type

Codes for the main intent of the study.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. ResearchStudy.phase
Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Shortn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Control10..1
BindingThe codes SHALL be taken from For example codes, see ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ResearchStudy.category
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control10..*
Binding

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
66. ResearchStudy.category:studyCategory
Slice NamestudyCategory
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control10..1*
BindingThe codes SHALL be taken from For example codes, see ValueSet Studienkategorien NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ResearchStudy.category:studyDesign
Slice NamestudyDesign
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..*
BindingThe codes SHALL be taken from For example codes, see ValueSet Studiendesign NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. ResearchStudy.category:typeOfBlinding
Slice NametypeOfBlinding
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..1*
BindingThe codes SHALL be taken from For example codes, see ValueSet Type of Blinding NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. ResearchStudy.category:typeOfRandomization
Slice NametypeOfRandomization
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..1*
BindingThe codes SHALL be taken from For example codes, see ValueSet Type of Randomization NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ResearchStudy.focus
Definition

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

ShortDrugs, devices, etc. under study
Control0..*
BindingUnless not suitable, these codes SHALL be taken from For example codes, see ValueSet Study Focus NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. ResearchStudy.arm
Definition

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.

ShortDefined path through the study for a subject
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. ResearchStudy.arm.modifierExtension
Definition

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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
80. ResearchStudy.arm.name
Definition

Unique, human-readable label for this arm of the study.

ShortLabel for study arm
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ResearchStudy.arm.type
Definition

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

ShortCategorization of study arm
Control0..1
BindingThe codes SHALL be taken from For codes, see ValueSet Type of Study Arm NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
Definition

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.

ShortInvestigation to increase healthcare-related patient-independent knowledge
Comments

Need to make sure we encompass public health studies.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesClinical Trial, Study
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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 (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())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ResearchStudy.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. ResearchStudy.meta
Definition

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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ResearchStudy.implicitRules
Definition

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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ResearchStudy.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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).

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchStudy.text
Definition

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 "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

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 "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
TypeNarrative
Is Modifierfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ResearchStudy.contained
Definition

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.

ShortContained, inline Resources
Comments

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.

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. ResearchStudy.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. ResearchStudy.modifierExtension
Definition

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).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. ResearchStudy.identifier
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
20. ResearchStudy.identifier:eudraCT
Slice NameeudraCT
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortEudra CT Number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.clinicaltrialsregister.eu&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ResearchStudy.identifier:eudraCT.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
24. ResearchStudy.identifier:eudraCT.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
26. ResearchStudy.identifier:eudraCT.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ResearchStudy.identifier:eudraCT.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. ResearchStudy.identifier:eudraCT.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://www.clinicaltrialsregister.eu
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. ResearchStudy.identifier:eudraCT.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ResearchStudy.identifier:eudraCT.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ResearchStudy.identifier:eudraCT.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ResearchStudy.identifier:NCT
Slice NameNCT
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortNCT number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://clinicaltrials.gov&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ResearchStudy.identifier:NCT.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
42. ResearchStudy.identifier:NCT.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
44. ResearchStudy.identifier:NCT.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ResearchStudy.identifier:NCT.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ResearchStudy.identifier:NCT.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttp://clinicaltrials.gov
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ResearchStudy.identifier:NCT.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. ResearchStudy.identifier:NCT.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ResearchStudy.identifier:NCT.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. ResearchStudy.identifier:PMID
Slice NamePMID
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortPubmed ID
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://www.ncbi.nlm.nih.gov/pubmed&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ResearchStudy.identifier:PMID.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
60. ResearchStudy.identifier:PMID.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
62. ResearchStudy.identifier:PMID.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ResearchStudy.identifier:PMID.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. ResearchStudy.identifier:PMID.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttp://www.ncbi.nlm.nih.gov/pubmed
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ResearchStudy.identifier:PMID.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. ResearchStudy.identifier:PMID.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. ResearchStudy.identifier:PMID.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ResearchStudy.identifier:DOI
Slice NameDOI
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortDigital Object Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://doi.org&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. ResearchStudy.identifier:DOI.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
78. ResearchStudy.identifier:DOI.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
80. ResearchStudy.identifier:DOI.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ResearchStudy.identifier:DOI.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ResearchStudy.identifier:DOI.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://doi.org
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ResearchStudy.identifier:DOI.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. ResearchStudy.identifier:DOI.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. ResearchStudy.identifier:DOI.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. ResearchStudy.identifier:URI
Slice NameURI
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortUniform Resource Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;urn:ietf:rfc:3986&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. ResearchStudy.identifier:URI.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
96. ResearchStudy.identifier:URI.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
98. ResearchStudy.identifier:URI.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. ResearchStudy.identifier:URI.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. ResearchStudy.identifier:URI.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valueurn:ietf:rfc:3986
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. ResearchStudy.identifier:URI.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. ResearchStudy.identifier:URI.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. ResearchStudy.identifier:URI.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. ResearchStudy.identifier:DRKS
Slice NameDRKS
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortDeusches Register Klinischer Studien
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Pattern Value&lt;valueIdentifier&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;system&nbsp;value=&quot;https://www.drks.de&quot;/&gt;<br/>&lt;/valueIdentifier&gt;<br/>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. ResearchStudy.identifier:DRKS.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
114. ResearchStudy.identifier:DRKS.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
116. ResearchStudy.identifier:DRKS.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. ResearchStudy.identifier:DRKS.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. ResearchStudy.identifier:DRKS.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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.

Pattern Valuehttps://www.drks.de
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. ResearchStudy.identifier:DRKS.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. ResearchStudy.identifier:DRKS.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. ResearchStudy.identifier:DRKS.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. ResearchStudy.title
Definition

A short, descriptive user-friendly label for the study.

ShortName for this study
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. ResearchStudy.protocol
Definition

The set of steps expected to be performed as part of the execution of the study.

ShortSteps followed in executing study
Control0..*
TypeReference(PlanDefinition)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. ResearchStudy.partOf
Definition

A larger research study of which this particular study is a component or step.

ShortPart of larger study
Control0..*
TypeReference(ResearchStudy)
Is Modifierfalse
Summarytrue
Requirements

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Alternate Namescontainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. ResearchStudy.status
Definition

The current state of the study.

Shortactive | 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
Control1..1
BindingThe codes SHALL be taken from ResearchStudyStatus

Codes that convey the current status of the research study.

Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. ResearchStudy.primaryPurposeType
Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

Shorttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Control0..1
BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType

Codes for the main intent of the study.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. ResearchStudy.phase
Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

Shortn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Control1..1
BindingThe codes SHALL be taken from ResearchStudyPhase
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. ResearchStudy.category
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control1..*
Binding

Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.category. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
142. ResearchStudy.category:studyCategory
Slice NamestudyCategory
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control1..1
BindingThe codes SHALL be taken from ValueSet Studienkategorien NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. ResearchStudy.category:studyDesign
Slice NamestudyDesign
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..*
BindingThe codes SHALL be taken from ValueSet Studiendesign NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. ResearchStudy.category:typeOfBlinding
Slice NametypeOfBlinding
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..1
BindingThe codes SHALL be taken from ValueSet Type of Blinding NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. ResearchStudy.category:typeOfRandomization
Slice NametypeOfRandomization
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortClassifications for the study
Control0..1
BindingThe codes SHALL be taken from ValueSet Type of Randomization NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
150. ResearchStudy.focus
Definition

The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

ShortDrugs, devices, etc. under study
Control0..*
BindingUnless not suitable, these codes SHALL be taken from ValueSet Study Focus NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. ResearchStudy.condition
Definition

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 "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

ShortCondition being studied
Control0..*
BindingFor example codes, see Condition/Problem/DiagnosisCodes

Identification of the condition or diagnosis.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. ResearchStudy.contact
Definition

Contact details to assist a user in learning more about or engaging with the study.

ShortContact details for the study
Control0..*
TypeContactDetail
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
156. ResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

ShortReferences and dependencies
Control0..*
TypeRelatedArtifact
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
158. ResearchStudy.keyword
Definition

Key terms to aid in searching for or filtering the study.

ShortUsed to search for the study
Control0..*
Binding

Words associated with the study that may be useful in discovery.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. ResearchStudy.location
Definition

Indicates a country, state or other region where the study is taking place.

ShortGeographic region(s) for study
Control0..*
BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSet

Countries and regions within which this artifact is targeted for use.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. ResearchStudy.description
Definition

A full description of how the study is being conducted.

ShortWhat this is study doing
Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
164. ResearchStudy.enrollment
Definition

Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".

ShortInclusion & exclusion criteria
Comments

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

Control0..*
TypeReference(Group)
Is Modifierfalse
Summarytrue
Alternate Namespatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. ResearchStudy.period
Definition

Identifies the start date and the expected (or actual, depending on status) end date for the study.

ShortWhen the study began and ended
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Alternate Namestiming
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
168. ResearchStudy.sponsor
Definition

An organization that initiates the investigation and is legally responsible for the study.

ShortOrganization that initiates and is legally responsible for the study
Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
170. ResearchStudy.principalInvestigator
Definition

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.

ShortResearcher who oversees multiple aspects of the study
Control0..1
TypeReference(Practitioner, PractitionerRole)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
172. ResearchStudy.site
Definition

A facility in which study activities are conducted.

ShortFacility where study activities are conducted
Control0..*
TypeReference(Location)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
174. ResearchStudy.reasonStopped
Definition

A description and/or code explaining the premature termination of the study.

Shortaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Control0..1
BindingFor example codes, see ResearchStudyReasonStopped

Codes for why the study ended prematurely.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
176. ResearchStudy.note
Definition

Comments made about the study by the performer, subject or other participants.

ShortComments made about the study
Control0..*
TypeAnnotation
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
178. ResearchStudy.arm
Definition

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.

ShortDefined path through the study for a subject
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
180. ResearchStudy.arm.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
182. ResearchStudy.arm.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
184. ResearchStudy.arm.modifierExtension
Definition

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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
186. ResearchStudy.arm.name
Definition

Unique, human-readable label for this arm of the study.

ShortLabel for study arm
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
188. ResearchStudy.arm.type
Definition

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

ShortCategorization of study arm
Control0..1
BindingThe codes SHALL be taken from ValueSet Type of Study Arm NCIt
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
190. ResearchStudy.arm.description
Definition

A succinct description of the path through the study that would be followed by a subject adhering to this arm.

ShortShort explanation of study path
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
192. ResearchStudy.objective
Definition

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.

ShortA goal for the study
Control0..*
TypeBackboneElement
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
194. ResearchStudy.objective.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
196. ResearchStudy.objective.extension
Definition

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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
198. ResearchStudy.objective.modifierExtension
Definition

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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
200. ResearchStudy.objective.name
Definition

Unique, human-readable label for this objective of the study.

ShortLabel for the objective
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
202. ResearchStudy.objective.type
Definition

The kind of study objective.

Shortprimary | secondary | exploratory
Control0..1
BindingThe codes SHOULD be taken from ResearchStudyObjectiveType

Codes for the kind of study objective.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))