NCPI FHIR Implementation Guide v2
0.1.0 - ci-build

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

Logical Model: Shared Data Model for Research Participants

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/SharedDataModelResearchParticipant Version: 0.1.0
Draft as of 2024-11-25 Computable Name: CdmResearchParticipant

The Shared Data Model for Research Participants

NCPI Participant

Participant

Participants are a scoped entity that represents the anchor for all data for a specific real-world entity. Typically, this is a person involved in a research study and all of their data collected for that study (or set of studies). This entity has direct attributes (eg, demographics), so if two studies that share an identifier space present conflicting information, it may be necessary to have multiple participants.

Participants (ie, data about an entity that is scope constrained) can be linked with a Person. Participants can be associated with different substudies (and with different data sharing restrictions) via Study Participation.

Person

In situations where a person participates in multiple studies that have participant data scoped in an exclusive way within one or more projects, we have a Person entity. It is functionally a “group” of Participants that are all describing one “actual” person. This is especially to support situations where access policies about that participant might be conflicting and cases where the data itself about the participant might conflict but cannot be adjudicated by the repository.

Study Participation

Study Participation (ResearchSubject) describes the relationship between a specific Participant and a Research Study that collects and is sharing data on that Participant. A single Participant may have this “Study Participation” relationship with multiple Research Studies, and each relationship may have a different sharing restriction. These relationships are primarily illustrative, as the Access Policy details of any given element are documented within that element.

Usage:

  • This Logical Model Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format

This structure is derived from Base

Summary

Mandatory: 0 element(2 nested mandatory elements)

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. SharedDataModelResearchParticipant 0..* Base Shared Data Model for Research Participants
Instances of this logical model are not marked to be the target of a Reference
... participantID 1..1 string Unique participant identifier. System identifier used for internal references.
... externalID 0..* code Unique participant identifier. System identifier used for internal references.
... population 0..* code Population, Race, and/or Ethnicity information.
... ombEth 0..* code OMB coded Ethnicity for backwards compatibility
... sex 1..1 code Sex assigned at birth (or pre-natal observed sex)
... dateOfBirth 0..1 date Date of Birth of the participant. Details of privacy method should be included in DOBMethod
... dobMethod 0..1 code Specifies method used to alter DOB for research sharing. Details should be available in the study protocols.
... ageAtLastVitalStatus 0..1 date Age at last vital status
... vitalStatus 0..1 code Vital Status

doco Documentation for this format

This structure is derived from Base

Summary

Mandatory: 0 element(2 nested mandatory elements)

 

Other representations of profile: CSV, Excel