HL7.FHIR.UV.CDISC-MAPPING\Demographics

This page is part of the CDISC Mapping FHIR IG (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Demographics

Demographic information in FHIR is captured using the Patient resource. Even if an individual isn't directly receiving care, if they're a potential subject of care, they're represented using Patient. The ResearchSubject resource is used to tie patients to specific research studies and to capture metadata about the patient's involvement with that study. In theory the same patient could be involved in many studies, some even at the same time.

DM Mappings

Guidance on interpreting the table can be found here.

CDISC	FHIR map (or gap)	Comment
Study ID or Number	STUDYID	STUDYID	ResearchStudy.identifier	ResearchSubject.where(subject=Patient.identifier).study.resolve().partOf.resolve().identifier
Study Site ID	SITEID	DM.SITEID	ResearchStudy.identifier	ResearchSubject.where(subject=Patient.identifier.study.resolve().identifier.value
Subject ID for the Study	SUBJID	DM.SUBJID	ResearchSubject.identifier	ResearchSubject.where(individual=Patient.identifier).identifier.value
Birth Date	BRTHDAT	BRTHDTC	Patient.birthDate	Patient.birthDate	There is potential where the birth date can not be collected due to country regulations. In those cases an estimated age may be entered. Birth time is captured as a standard extension
Birth Day	BRTHDD	BRTHDTC	Patient.birthDate	Patient.birthDate.substring(8,4)
Birth Month	BRTHMO	BRTHDTC	Patient.birthDate	Patient.birthDate.substring(5,2)
Birth Year	BRTHYY	BRTHDTC	Patient.birthDate	Patient.birthDate.substring(0,4)
Birth Time	BRTHTIM	BRTHDTC	Patient.extension	Patient.extension(patient-birthTime).valueTime
Age	AGE	AGE	There is potential where the birth date can not be collected due to country regulations. Age can be captured as an Observation as a point-in-time assessment, but generally this is simply calculated from birthDate
Age Units	AGEU	AGEU	Age can be captured as an Observation as a point-in-time assessment, but generally this is simply calculated from birthDate
Demographics Collection Date	DMDAT	DMDTC	Patient.meta.lastUpdated	Patient.meta.lastUpdated	This indicates when the Patient resource was last changed, but in practice different pieces of demographics are collected at different times. Review will be required of the history of the patient resource to determine when any particular fact was first asserted.
Sex	SEX	SEX	Patient.gender	Patient.gender	Note that gender represents the gender for administrative purposes. Genetic, physiologic, social and other gender aspects are captured as Observations
Ethnicity	ETHNIC	ETHNIC	There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-ethnicity.html) for this to capture ethnicity as required by U.S. legislation. It captures two distinct granularities as well as free text. Depending on the study, the higher or lower granularity might map to ETHNIC and the lower or free text could map to CETHNIC. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation
Collected Ethnicity	CETHNIC	SUPPDM.QVAL	There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-ethnicity.html) for this to capture ethnicity as required by U.S. legislation. It captures two distinct granularities as well as free text. Depending on the study, the higher or lower granularity might map to ETHNIC and the lower or free text could map to CETHNIC. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation
Race	RACE	RACE	There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-race.html) for this to capture race as required by U.S. legislation. In theory, the OMBRace could map to RACE, 'detailed' could map to CRACE and 'text' could map to RACEOTH. However, how appropriate these mappings would be would depend on the study requirements. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation
Collected Race	CRACE	SUPPDM.QVAL	There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-race.html) for this to capture race as required by U.S. legislation. In theory, the OMBRace could map to RACE, 'detailed' could map to CRACE and 'text' could map to RACEOTH. However, how appropriate these mappings would be would depend on the study requirements. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation
Race Other	RACEOTH		There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-race.html) for this to capture race as required by U.S. legislation. In theory, the OMBRace could map to RACE, 'detailed' could map to CRACE and 'text' could map to RACEOTH. However, how appropriate these mappings would be would depend on the study requirements. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation

CDISC

FHIR map (or gap)

Comment

Name

CDASH

SDTM

Element

FHIRPath

Study ID or Number

STUDYID

ResearchStudy.identifier

ResearchSubject.where(subject=Patient.identifier).study.resolve().partOf.resolve().identifier

Study Site ID

SITEID

DM.SITEID

ResearchStudy.identifier

ResearchSubject.where(subject=Patient.identifier.study.resolve().identifier.value

Subject ID for the Study

SUBJID

DM.SUBJID

ResearchSubject.identifier

ResearchSubject.where(individual=Patient.identifier).identifier.value

Birth Date

BRTHDAT

BRTHDTC

Patient.birthDate

There is potential where the birth date can not be collected due to country regulations. In those cases an estimated age may be entered.

Birth time is captured as a standard extension

Birth Day

BRTHDD

BRTHDTC

Patient.birthDate

Patient.birthDate.substring(8,4)

Birth Month

BRTHMO

BRTHDTC

Patient.birthDate

Patient.birthDate.substring(5,2)

Birth Year

BRTHYY

BRTHDTC

Patient.birthDate

Patient.birthDate.substring(0,4)

Birth Time

BRTHTIM

BRTHDTC

Patient.extension

Patient.extension(patient-birthTime).valueTime

Age

AGE

There is potential where the birth date can not be collected due to country regulations.

Age can be captured as an Observation as a point-in-time assessment, but generally this is simply calculated from birthDate

Age Units

AGEU

Age can be captured as an Observation as a point-in-time assessment, but generally this is simply calculated from birthDate

Demographics Collection Date

DMDAT

DMDTC

Patient.meta.lastUpdated

This indicates when the Patient resource was last changed, but in practice different pieces of demographics are collected at different times. Review will be required of the history of the patient resource to determine when any particular fact was first asserted.

Sex

SEX

Patient.gender

Note that gender represents the gender for administrative purposes. Genetic, physiologic, social and other gender aspects are captured as Observations

Ethnicity

ETHNIC

There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-ethnicity.html) for this to capture ethnicity as required by U.S. legislation. It captures two distinct granularities as well as free text. Depending on the study, the higher or lower granularity might map to ETHNIC and the lower or free text could map to CETHNIC. Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation

Collected Ethnicity

CETHNIC

SUPPDM.QVAL

Race

RACE

There's a U.S. Core extension (https://build.fhir.org/ig/HL7/US-Core-R4/StructureDefinition-us-core-race.html) for this to capture race as required by U.S. legislation. In theory, the OMBRace could map to RACE, 'detailed' could map to CRACE and 'text' could map to RACEOTH. However, how appropriate these mappings would be would depend on the study requirements.

Other countries use vastly different value sets or prohibit collection. If captured for clinical rather than administrative purposes, this would be an Observation

Collected Race

CRACE

SUPPDM.QVAL

Race Other

RACEOTH