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

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Resource Profile: NCPI Research Study Group

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: Participants from the GREGoR research study GSS U08 GRU and Participants from the CBTN research study

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

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 Description (No ValueSet): (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: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from 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 Additional Bindings Purpose AllLanguages Max Binding 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 Description (No ValueSet): (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 Description (No ValueSet): (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 Description (No ValueSet): (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 Constraints Path Conformance ValueSet / Code URI Group.language preferred CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Group.type required Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard Group.code example Pattern: C142710("Study Participant") Group.characteristic.code example Group.characteristic.value[x] example 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 Summary Mandatory: 1 element 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 Description (No ValueSet): (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: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from 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 Additional Bindings Purpose AllLanguages Max Binding 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 Description (No ValueSet): (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 Description (No ValueSet): (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 Description (No ValueSet): (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 Constraints Path Conformance ValueSet / Code URI Group.language preferred CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Group.type required Pattern: person http://hl7.org/fhir/ValueSet/group-type|4.3.0 from the FHIR Standard Group.code example Pattern: C142710("Study Participant") Group.characteristic.code example Group.characteristic.value[x] example 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 Summary Mandatory: 1 element   Other representations of profile: CSV, Excel, Schematron IG © 2023+ NCPI FHIR Working Group. Package ncpi-fhir-implementation-guide-v2#0.1.0 based on FHIR 4.3.0. Generated 2024-11-25 Links: Table of Contents | QA Report