German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
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 | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Must Support | true |
Slicing | This element introduces a set of slices on ResearchStudy.identifier . The slices are unordered and Open, and can be differentiated using the following discriminators: |
4. ResearchStudy.identifier:eudraCT | |
Slice Name | eudraCT |
Short | Eudra CT Number |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.clinicaltrialsregister.eu"/><br/></valueIdentifier><br/> |
6. ResearchStudy.identifier:eudraCT.system | |
Control | 1..? |
Must Support | true |
Pattern Value | https://www.clinicaltrialsregister.eu |
8. ResearchStudy.identifier:eudraCT.value | |
Control | 1..? |
Must Support | true |
10. ResearchStudy.identifier:NCT | |
Slice Name | NCT |
Short | NCT number |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://clinicaltrials.gov"/><br/></valueIdentifier><br/> |
12. ResearchStudy.identifier:NCT.system | |
Control | 1..? |
Must Support | true |
Pattern Value | http://clinicaltrials.gov |
14. ResearchStudy.identifier:NCT.value | |
Control | 1..? |
Must Support | true |
16. ResearchStudy.identifier:PMID | |
Slice Name | PMID |
Short | Pubmed ID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://www.ncbi.nlm.nih.gov/pubmed"/><br/></valueIdentifier><br/> |
18. ResearchStudy.identifier:PMID.system | |
Control | 1..? |
Must Support | true |
Pattern Value | http://www.ncbi.nlm.nih.gov/pubmed |
20. ResearchStudy.identifier:PMID.value | |
Control | 1..? |
Must Support | true |
22. ResearchStudy.identifier:DOI | |
Slice Name | DOI |
Short | Digital Object Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://doi.org"/><br/></valueIdentifier><br/> |
24. ResearchStudy.identifier:DOI.system | |
Control | 1..? |
Must Support | true |
Pattern Value | https://doi.org |
26. ResearchStudy.identifier:DOI.value | |
Control | 1..? |
Must Support | true |
28. ResearchStudy.identifier:URI | |
Slice Name | URI |
Short | Uniform Resource Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="urn:ietf:rfc:3986"/><br/></valueIdentifier><br/> |
30. ResearchStudy.identifier:URI.system | |
Control | 1..? |
Must Support | true |
Pattern Value | urn:ietf:rfc:3986 |
32. ResearchStudy.identifier:URI.value | |
Control | 1..? |
Must Support | true |
34. ResearchStudy.identifier:DRKS | |
Slice Name | DRKS |
Short | Deusches Register Klinischer Studien |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Pattern Value | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.drks.de"/><br/></valueIdentifier><br/> |
36. ResearchStudy.identifier:DRKS.system | |
Control | 1..? |
Must Support | true |
Pattern Value | https://www.drks.de |
38. ResearchStudy.identifier:DRKS.value | |
Control | 1..? |
Must Support | true |
40. ResearchStudy.title | |
Must Support | true |
42. ResearchStudy.status | |
Must Support | true |
44. ResearchStudy.primaryPurposeType | |
Must Support | true |
46. ResearchStudy.phase | |
Control | 1..? |
Binding | The codes SHALL be taken from ResearchStudyPhase |
48. ResearchStudy.category | |
Control | 1..? |
Must Support | true |
Slicing | This element introduces a set of slices on ResearchStudy.category . The slices are unordered and Open, and can be differentiated using the following discriminators: |
50. ResearchStudy.category:studyCategory | |
Slice Name | studyCategory |
Control | 1..1 |
Binding | The codes SHALL be taken from ValueSet Studienkategorien NCIt |
Must Support | true |
52. ResearchStudy.category:studyDesign | |
Slice Name | studyDesign |
Control | 0..* |
Binding | The codes SHALL be taken from ValueSet Studiendesign NCIt |
Must Support | true |
54. ResearchStudy.category:typeOfBlinding | |
Slice Name | typeOfBlinding |
Control | 0..1 |
Binding | The codes SHALL be taken from ValueSet Type of Blinding NCIt |
Must Support | true |
56. ResearchStudy.category:typeOfRandomization | |
Slice Name | typeOfRandomization |
Control | 0..1 |
Binding | The codes SHALL be taken from ValueSet Type of Randomization NCIt |
Must Support | true |
58. ResearchStudy.focus | |
Binding | Unless not suitable, these codes SHALL be taken from ValueSet Study Focus NCIt |
Must Support | true |
60. ResearchStudy.arm | |
Must Support | true |
62. ResearchStudy.arm.type | |
Binding | The codes SHALL be taken from ValueSet Type of Study Arm NCIt |
Must Support | true |
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. |
Short | Investigation to increase healthcare-related patient-independent knowledge |
Comments | Need to make sure we encompass public health studies. |
Control | 0..* |
Is Modifier | false |
Summary | false |
Alternate Names | Clinical Trial, Study |
Invariants | dom-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. |
Short | A 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-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). |
Short | Extensions 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Summary | false |
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 Names | extensions, user content |
Invariants | ele-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. |
Short | Business Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | true |
Summary | true |
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on ResearchStudy.identifier . The slices are unordered and Open, and can be differentiated using the following discriminators: |
8. ResearchStudy.identifier:eudraCT | |
Slice Name | eudraCT |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Eudra CT NumberBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.clinicaltrialsregister.eu"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | https://www.clinicaltrialsregister.eu |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. ResearchStudy.identifier:NCT | |
Slice Name | NCT |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | NCT numberBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://clinicaltrials.gov"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | http://clinicaltrials.gov |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. ResearchStudy.identifier:PMID | |
Slice Name | PMID |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Pubmed IDBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://www.ncbi.nlm.nih.gov/pubmed"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | http://www.ncbi.nlm.nih.gov/pubmed |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
32. ResearchStudy.identifier:DOI | |
Slice Name | DOI |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Digital Object IdentifierBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://doi.org"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | https://doi.org |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. ResearchStudy.identifier:URI | |
Slice Name | URI |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Uniform Resource IdentifierBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="urn:ietf:rfc:3986"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | urn:ietf:rfc:3986 |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
48. ResearchStudy.identifier:DRKS | |
Slice Name | DRKS |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Deusches Register Klinischer StudienBusiness Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Summary | true |
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.drks.de"/><br/></valueIdentifier><br/> |
Invariants | ele-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. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1 Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-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. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
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 Value | https://www.drks.de |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-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. |
Short | The 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. |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-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. |
Short | Name for this study |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-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. |
Short | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn |
Control | 1..1 |
Binding | The 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. |
Type | code |
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-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. |
Short | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility |
Control | 0..1 |
Binding | Unless 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. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-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. |
Short | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 |
Control | 10..1 |
Binding | The codes SHALL be taken from For example codes, see ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Invariants | ele-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. |
Short | Classifications for the study |
Control | 10..* |
Binding | Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on ResearchStudy.category . The slices are unordered and Open, and can be differentiated using the following discriminators: |
66. ResearchStudy.category:studyCategory | |
Slice Name | studyCategory |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short | Classifications for the study |
Control | 10..1* |
Binding | The codes SHALL be taken from For example codes, see ValueSet Studienkategorien NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
68. ResearchStudy.category:studyDesign | |
Slice Name | studyDesign |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short | Classifications for the study |
Control | 0..* |
Binding | The codes SHALL be taken from For example codes, see ValueSet Studiendesign NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
70. ResearchStudy.category:typeOfBlinding | |
Slice Name | typeOfBlinding |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short | Classifications for the study |
Control | 0..1* |
Binding | The codes SHALL be taken from For example codes, see ValueSet Type of Blinding NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
72. ResearchStudy.category:typeOfRandomization | |
Slice Name | typeOfRandomization |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short | Classifications for the study |
Control | 0..1* |
Binding | The codes SHALL be taken from For example codes, see ValueSet Type of Randomization NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-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. |
Short | Drugs, devices, etc. under study |
Control | 0..* |
Binding | Unless not suitable, these codes SHALL be taken from For example codes, see ValueSet Study Focus NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-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. |
Short | Defined path through the study for a subject |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | false |
Invariants | ele-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). |
Short | Extensions 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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 Names | extensions, user content, modifiers |
Invariants | ele-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. |
Short | Label for study arm |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | false |
Invariants | ele-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. |
Short | Categorization of study arm |
Control | 0..1 |
Binding | The codes SHALL be taken from For codes, see ValueSet Type of Study Arm NCIt |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | false |
Invariants | ele-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. | ||||
Short | Investigation to increase healthcare-related patient-independent knowledge | ||||
Comments | Need to make sure we encompass public health studies. | ||||
Control | 0..* | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | Clinical Trial, Study | ||||
Invariants | dom-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. | ||||
Short | Logical 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. | ||||
Control | 0..1 | ||||
Type | id | ||||
Is Modifier | false | ||||
Summary | true | ||||
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. | ||||
Short | Metadata about the resource | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | A 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. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Language 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). | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages A human language.
| ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Text 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. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Invariants | ele-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. | ||||
Short | Contained, 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. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | inline 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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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). | ||||
Short | Extensions 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
Summary | false | ||||
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 Names | extensions, user content | ||||
Invariants | ele-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. | ||||
Short | Business Identifier for study | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
20. ResearchStudy.identifier:eudraCT | |||||
Slice Name | eudraCT | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | Eudra CT Number | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.clinicaltrialsregister.eu"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
26. ResearchStudy.identifier:eudraCT.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | https://www.clinicaltrialsregister.eu | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
38. ResearchStudy.identifier:NCT | |||||
Slice Name | NCT | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | NCT number | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://clinicaltrials.gov"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
44. ResearchStudy.identifier:NCT.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | http://clinicaltrials.gov | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
56. ResearchStudy.identifier:PMID | |||||
Slice Name | PMID | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | Pubmed ID | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="http://www.ncbi.nlm.nih.gov/pubmed"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
62. ResearchStudy.identifier:PMID.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | http://www.ncbi.nlm.nih.gov/pubmed | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
74. ResearchStudy.identifier:DOI | |||||
Slice Name | DOI | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | Digital Object Identifier | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://doi.org"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
80. ResearchStudy.identifier:DOI.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | https://doi.org | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
92. ResearchStudy.identifier:URI | |||||
Slice Name | URI | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | Uniform Resource Identifier | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="urn:ietf:rfc:3986"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
98. ResearchStudy.identifier:URI.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | urn:ietf:rfc:3986 | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
110. ResearchStudy.identifier:DRKS | |||||
Slice Name | DRKS | ||||
Definition | Identifiers assigned to this research study by the sponsor or other systems. | ||||
Short | Deusches Register Klinischer Studien | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
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 | <valueIdentifier xmlns="http://hl7.org/fhir"><br/> <system value="https://www.drks.de"/><br/></valueIdentifier><br/> | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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() ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.identifier.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
116. ResearchStudy.identifier:DRKS.use | |||||
Definition | The purpose of this identifier. | ||||
Short | usual | official | temp | secondary | old (If known) | ||||
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known . | ||||
Type | code | ||||
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||||
Invariants | ele-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. | ||||
Short | Description 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. | ||||
Control | 0..1 | ||||
Binding | Unless 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. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Invariants | ele-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. | ||||
Short | The namespace for the identifier value | ||||
Comments | Identifier.system is always case sensitive. | ||||
Control | 1..1 | ||||
Type | uri | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
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 Value | https://www.drks.de | ||||
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient | ||||
Invariants | ele-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. | ||||
Short | The 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. | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Example | <br/><b>General</b>:123456 | ||||
Invariants | ele-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. | ||||
Short | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Organization 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. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Name for this study | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Steps followed in executing study | ||||
Control | 0..* | ||||
Type | Reference(PlanDefinition) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Part of larger study | ||||
Control | 0..* | ||||
Type | Reference(ResearchStudy) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. | ||||
Alternate Names | container | ||||
Invariants | ele-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. | ||||
Short | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ResearchStudyStatus Codes that convey the current status of the research study. | ||||
Type | code | ||||
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility | ||||
Control | 0..1 | ||||
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType Codes for the main intent of the study. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ResearchStudyPhase | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Classifications for the study | ||||
Control | 1..* | ||||
Binding | Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
Slicing | This element introduces a set of slices on ResearchStudy.category . The slices are unordered and Open, and can be differentiated using the following discriminators: | ||||
142. ResearchStudy.category:studyCategory | |||||
Slice Name | studyCategory | ||||
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. | ||||
Short | Classifications for the study | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ValueSet Studienkategorien NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
144. ResearchStudy.category:studyDesign | |||||
Slice Name | studyDesign | ||||
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. | ||||
Short | Classifications for the study | ||||
Control | 0..* | ||||
Binding | The codes SHALL be taken from ValueSet Studiendesign NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
146. ResearchStudy.category:typeOfBlinding | |||||
Slice Name | typeOfBlinding | ||||
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. | ||||
Short | Classifications for the study | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from ValueSet Type of Blinding NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
148. ResearchStudy.category:typeOfRandomization | |||||
Slice Name | typeOfRandomization | ||||
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. | ||||
Short | Classifications for the study | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from ValueSet Type of Randomization NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Drugs, devices, etc. under study | ||||
Control | 0..* | ||||
Binding | Unless not suitable, these codes SHALL be taken from ValueSet Study Focus NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Condition being studied | ||||
Control | 0..* | ||||
Binding | For example codes, see Condition/Problem/DiagnosisCodes Identification of the condition or diagnosis. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Contact details for the study | ||||
Control | 0..* | ||||
Type | ContactDetail | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | References and dependencies | ||||
Control | 0..* | ||||
Type | RelatedArtifact | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Used to search for the study | ||||
Control | 0..* | ||||
Binding | Words associated with the study that may be useful in discovery. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Geographic region(s) for study | ||||
Control | 0..* | ||||
Binding | Unless not suitable, these codes SHALL be taken from Jurisdiction ValueSet Countries and regions within which this artifact is targeted for use. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | What this is study doing | ||||
Control | 0..1 | ||||
Type | markdown | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-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". | ||||
Short | Inclusion & exclusion criteria | ||||
Comments | The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. | ||||
Control | 0..* | ||||
Type | Reference(Group) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Alternate Names | patient | ||||
Invariants | ele-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. | ||||
Short | When the study began and ended | ||||
Control | 0..1 | ||||
Type | Period | ||||
Is Modifier | false | ||||
Summary | true | ||||
Alternate Names | timing | ||||
Invariants | ele-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. | ||||
Short | Organization that initiates and is legally responsible for the study | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Researcher who oversees multiple aspects of the study | ||||
Control | 0..1 | ||||
Type | Reference(Practitioner, PractitionerRole) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Facility where study activities are conducted | ||||
Control | 0..* | ||||
Type | Reference(Location) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design | ||||
Control | 0..1 | ||||
Binding | For example codes, see ResearchStudyReasonStopped Codes for why the study ended prematurely. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-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. | ||||
Short | Comments made about the study | ||||
Control | 0..* | ||||
Type | Annotation | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Defined path through the study for a subject | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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). | ||||
Short | Extensions 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
Summary | true | ||||
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 Names | extensions, user content, modifiers | ||||
Invariants | ele-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. | ||||
Short | Label for study arm | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Categorization of study arm | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from ValueSet Type of Study Arm NCIt | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Short explanation of study path | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | A goal for the study | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Short | Additional 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-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). | ||||
Short | Extensions 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
Summary | true | ||||
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 Names | extensions, user content, modifiers | ||||
Invariants | ele-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. | ||||
Short | Label for the objective | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-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. | ||||
Short | primary | secondary | exploratory | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType Codes for the kind of study objective. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |