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 Research Study Group
| Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/research-study-group | Version: 0.1.0 | |||
| Draft as of 2024-03-21 | Computable Name: ResearchStudyGroup | |||
Grouping subject participation within a research study is helpful to provide definitive lists of participants that fit a specific criteria such as All Participants or Participants From a Particular Consent Group, etc.
Usage:
- Examples for this Resource Profile: BM-CMG Study HMB-NPU Participants, BM-CMG Study IRB-HMB-NPU Participants and Participants from the CBTN research study
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Group
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Group | 0..* | Group | Group of multiple entities | |
  type | 1..1 | code | person | animal | practitioner | device | medication | substance Required Pattern: person | |
| actual | 1..1 | boolean | Descriptive or actual Required Pattern: true | |
 code | 0..1 | CodeableConcept | Kind of Group members Required Pattern: At least the following | |
   coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
 system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |
 display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |
| quantity | 1..1 | unsignedInt | Number of members | |
| member | ||||
 entity | 1..1 | Reference(Patient) | Reference to the group member | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Group | C | 0..* | Group | Group of multiple entities grp-1: Can only have members if group is "actual" |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| type | Σ | 1..1 | code | person | animal | practitioner | device | medication | substance Binding: GroupType (required): Types of resources that are part of group. Required Pattern: person |
| actual | ΣC | 1..1 | boolean | Descriptive or actual Required Pattern: true |
 code | Σ | 0..1 | CodeableConcept | Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |
| quantity | Σ | 1..1 | unsignedInt | Number of members |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet / Code | URI |
| Group.type | required | Pattern: personhttp://hl7.org/fhir/ValueSet/group-type|4.3.0from the FHIR Standard | |
| Group.code | example | Pattern: C142710("Study Participant") |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Group | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Group | 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 | Group | 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 | Group | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Group | 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() | |
| grp-1 | error | Group | Can only have members if group is "actual" : member.empty() or (actual = true) |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Group | C | 0..* | Group | Group of multiple entities grp-1: Can only have members if group is "actual" | ||||
| 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 | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Unique id | ||||
| active | Σ | 0..1 | boolean | Whether this group's record is in active use | ||||
| type | Σ | 1..1 | code | person | animal | practitioner | device | medication | substance Binding: GroupType (required): Types of resources that are part of group. Required Pattern: person | ||||
| actual | ΣC | 1..1 | boolean | Descriptive or actual Required Pattern: true | ||||
| code | Σ | 0..1 | CodeableConcept | Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| name | Σ | 0..1 | string | Label for Group | ||||
| quantity | Σ | 1..1 | unsignedInt | Number of members | ||||
| managingEntity | Σ | 0..1 | Reference(Organization | RelatedPerson | Practitioner | PractitionerRole) | Entity that is the custodian of the Group's definition | ||||
| characteristic | 0..* | BackboneElement | Include / Exclude group members by Trait | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | 1..1 | CodeableConcept | Kind of characteristic Binding: (unbound) (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc. | |||||
 value[x] | 1..1 | Value held by characteristic Binding: (unbound) (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc. | ||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueBoolean | boolean | |||||||
| valueQuantity | Quantity | |||||||
| valueRange | Range | |||||||
| valueReference | Reference(Any) | |||||||
| exclude | 1..1 | boolean | Group includes or excludes | |||||
| period | 0..1 | Period | Period over which characteristic is tested | |||||
| member | C | 0..* | BackboneElement | Who or what is in group | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| entity | 1..1 | Reference(Patient) | Reference to the group member | |||||
| period | 0..1 | Period | Period member belonged to the group | |||||
| inactive | 0..1 | boolean | If member is no longer in group | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet / Code | URI | |||
| Group.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Group.type | required | Pattern: personhttp://hl7.org/fhir/ValueSet/group-type|4.3.0from the FHIR Standard | ||||
| Group.code | example | Pattern: C142710("Study Participant") | ||||
| Group.characteristic.code | example | |||||
| Group.characteristic.value[x] | example |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Group | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Group | 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 | Group | 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 | Group | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Group | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | Group.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() | |
| grp-1 | error | Group | Can only have members if group is "actual" : member.empty() or (actual = true) |
This structure is derived from Group
Differential View
This structure is derived from Group
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Group | 0..* | Group | Group of multiple entities | |
| type | 1..1 | code | person | animal | practitioner | device | medication | substance Required Pattern: person | |
| actual | 1..1 | boolean | Descriptive or actual Required Pattern: true | |
| code | 0..1 | CodeableConcept | Kind of Group members Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |
| quantity | 1..1 | unsignedInt | Number of members | |
| member | ||||
| entity | 1..1 | Reference(Patient) | Reference to the group member | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Group | C | 0..* | Group | Group of multiple entities grp-1: Can only have members if group is "actual" |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| type | Σ | 1..1 | code | person | animal | practitioner | device | medication | substance Binding: GroupType (required): Types of resources that are part of group. Required Pattern: person |
| actual | ΣC | 1..1 | boolean | Descriptive or actual Required Pattern: true |
| code | Σ | 0..1 | CodeableConcept | Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |
| quantity | Σ | 1..1 | unsignedInt | Number of members |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet / Code | URI |
| Group.type | required | Pattern: personhttp://hl7.org/fhir/ValueSet/group-type|4.3.0from the FHIR Standard | |
| Group.code | example | Pattern: C142710("Study Participant") |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Group | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Group | 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 | Group | 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 | Group | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Group | 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() | |
| grp-1 | error | Group | Can only have members if group is "actual" : member.empty() or (actual = true) |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Group | C | 0..* | Group | Group of multiple entities grp-1: Can only have members if group is "actual" | ||||
| 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 | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Unique id | ||||
| active | Σ | 0..1 | boolean | Whether this group's record is in active use | ||||
| type | Σ | 1..1 | code | person | animal | practitioner | device | medication | substance Binding: GroupType (required): Types of resources that are part of group. Required Pattern: person | ||||
| actual | ΣC | 1..1 | boolean | Descriptive or actual Required Pattern: true | ||||
| code | Σ | 0..1 | CodeableConcept | Kind of Group members Binding: (unbound) (example): Kind of particular resource; e.g. cow, syringe, lake, etc. Required Pattern: At least the following | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://purl.obolibrary.org/obo/ncit.owl | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C142710 | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Study Participant | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| name | Σ | 0..1 | string | Label for Group | ||||
| quantity | Σ | 1..1 | unsignedInt | Number of members | ||||
| managingEntity | Σ | 0..1 | Reference(Organization | RelatedPerson | Practitioner | PractitionerRole) | Entity that is the custodian of the Group's definition | ||||
| characteristic | 0..* | BackboneElement | Include / Exclude group members by Trait | |||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code | 1..1 | CodeableConcept | Kind of characteristic Binding: (unbound) (example): List of characteristics used to describe group members; e.g. gender, age, owner, location, etc. | |||||
| value[x] | 1..1 | Value held by characteristic Binding: (unbound) (example): Value of descriptive member characteristic; e.g. red, male, pneumonia, Caucasian, etc. | ||||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueBoolean | boolean | |||||||
| valueQuantity | Quantity | |||||||
| valueRange | Range | |||||||
| valueReference | Reference(Any) | |||||||
| exclude | 1..1 | boolean | Group includes or excludes | |||||
| period | 0..1 | Period | Period over which characteristic is tested | |||||
| member | C | 0..* | BackboneElement | Who or what is in group | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| entity | 1..1 | Reference(Patient) | Reference to the group member | |||||
| period | 0..1 | Period | Period member belonged to the group | |||||
| inactive | 0..1 | boolean | If member is no longer in group | |||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Conformance | ValueSet / Code | URI | |||
| Group.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Group.type | required | Pattern: personhttp://hl7.org/fhir/ValueSet/group-type|4.3.0from the FHIR Standard | ||||
| Group.code | example | Pattern: C142710("Study Participant") | ||||
| Group.characteristic.code | example | |||||
| Group.characteristic.value[x] | example |
Constraints
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Group | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Group | 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 | Group | 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 | Group | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Group | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | Group.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() | |
| grp-1 | error | Group | Can only have members if group is "actual" : member.empty() or (actual = true) |
This structure is derived from Group
Other representations of profile: CSV, Excel, Schematron