NCPI FHIR Implementation Guide v2 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Resource Profile: NCPI Study Participant
| Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-Study-Participant | Version: 0.1.0 | |||
| Draft as of 2024-11-25 | Computable Name: NcpiStudyParticipant | |||
Research Study
Usage:
- Examples for this Resource Profile: ResearchSubject/gregor-example-participantstudy
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
   access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |
  study |
1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with | |
  individual |
1..1 | Reference(NCPI Participant) | The participant we are describing | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| study |
Σ | 1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with |
| individual |
Σ | 1..1 | Reference(NCPI Participant) | The participant we are describing |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.3.0from the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchSubject | 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.exists() and ('#'+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(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchSubject | 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 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
 meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with | ||||
| individual |
Σ | 1..1 | Reference(NCPI Participant) | The participant we are describing | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
0..1 | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.3.0from the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchSubject | 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.exists() and ('#'+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(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchSubject | 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 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | ResearchSubject.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ResearchSubject
Differential View
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |
| study |
1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with | |
| individual |
1..1 | Reference(NCPI Participant) | The participant we are describing | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| study |
Σ | 1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with |
| individual |
Σ | 1..1 | Reference(NCPI Participant) | The participant we are describing |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.3.0from the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchSubject | 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.exists() and ('#'+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(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchSubject | 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 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| access-policy |
0..* | Reference(NCPI Research Access Policy) | The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(ResearchStudy) | The Research Study this participant has a relationship with | ||||
| individual |
Σ | 1..1 | Reference(NCPI Participant) | The participant we are describing | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
0..1 | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.3.0from the FHIR Standard |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchSubject | 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.exists() and ('#'+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(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ResearchSubject | 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 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | ResearchSubject.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ResearchSubject
Other representations of profile: CSV, Excel, Schematron