HL7.FHIR.UV.CDISC-MAPPING\Medical History

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

Medical History

Medical history could include information from a wide range of FHIR resources. However, the most typical resources are:

AdverseEvent - These would be filtered to only extract issues that would not qualify as 'adverse events', but were still potentially study-relevant (perhaps having occurred prior to the study).
AllergyIntolerance - captures both the propensity to reaction as well as specific reaction occurrences
Condition - used to capture healthcare problems as well as other conditions (e.g. pregnancy)
Observation - captures symptoms, assessments, non-study pertinent lab results (e.g. blood type), etc.

Mappings are provided for all of these.

MH 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(individual=(AdverseEvent.subject\|Condition.subject\|AllergyIntolerance.patient\|Observation.subject).study.resolve().partOf.resolve().identifier.value AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value Condition.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the AdverseEvent/Condition/AllergyIntolerance/Observation is aware of its relevance to the Study.
Study Site ID	SITEID	DM.SITEID	ResearchStudy.site	ResearchSubject.where(individual=(AdverseEvent.subject\|Condition.subject\|AllergyIntolerance.patient\|Observation.subject).study.resolve().identifier.value AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().identifier.value Condition.extension(workflow-researchstudy).valueReference.resolve().identifier.value AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().identifier.value Observation.extension(workflow-researchstudy).valueReference.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the AdverseEvent/Condition/AllergyIntolerance/Observation is aware of its relevance to the Study.
Subject ID for the Study	SUBJID	DM.SUBJID	ResearchSubject.identifier	ResearchSubject.where(individual=(AdverseEvent.subject\|Condition.subject\|AllergyIntolerance.patient\|Observation.subject)).identifer.value	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the focal resource. No standard way to decide which subject identifier to use
Any Medical History Event	MHYN		If captured, this would be a Questionnaire question. FHIR almost always has some type of history information. Will require review to determine if the history is relevant.
Category for Medical History	MHCAT	MHCAT	Condition.category	Condition.category	The sponsors does not typically require this information from the sites. If needed there are several options to categorize this based on whether something is a Condition/AllergyIntolerance/Observation/etc. This could also include sub-categorize by diagnosis vs. problem, Allergy vs. intolerance or use Observation.category. But in general, the mapping to both CAT and SCAT is going to be driven by what types of categories the study requires or needs.
AdverseEvent.category	AdverseEvent.category
AllergyIntolerance.category	AllergyIntolerance.category
Observation.category	Observation.category
Subcategory for Medical History	MHSCAT	MHSCAT	Condition.category	Condition.category	The sponsors does not typically require this information from the sites. If needed there are several options to categorize this based on whether something is a Condition/AllergyIntolerance/Observation/etc. This could also include sub-categorize by diagnosis vs. problem, Allergy vs. intolerance or use Observation.category. But in general, the mapping to both CAT and SCAT is going to be driven by what types of categories the study requires or needs.
AdverseEvent.category	AdverseEvent.category
AllergyIntolerance.category	AllergyIntolerance.category
Observation.category	Observation.category
Medical History Collection Date	MHDAT	MHDAT	Condition.recordedDate	Condition.recordedDate
AdverseEvent.recordedDate	AdverseEvent.recordedDate
AllergyIntolerance.recordedDate	AllergyIntolerance.recordedDate
Observation.effectiveDteTime	Observaton.effectiveDateTime
MH Sponsor Defined Identifier	MHSPID	MHSPID	Condition.identifier	Condition.identifier	If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping.
AdverseEvent.identifier	AdverseEvent.identifier
AllergyIntolerance.identifier	AlergyIntolerance.identifier
Observation.identifier	Observation.identifier
Medical History Event Date Type	MHEVDTYP	SUPPMH.QVAL	Condition.onset	Condition.onset
AdverseEvent.date	AdverseEvent.date
AllergyIntolerance.onsetDateTime	AllergyIntolerance.onsetDateTime
AllergyIntolerance.onsetRange	AllergyIntolerance.onsetRange
AllergyIntolerance.onsetString	AllergyIntolerance.onsetString
Observation.effectiveDateTime	Observation.effectiveDateTime
Observation.effectivePeriod	Observation.effectivePeriod
Observation.effectiveTiming	Observation.effectiveTiming
Observation.effectiveInstant	Observaton.effectiveInstant
Reported Term for Medical History	MHTERM	MHTERM	Condition.code	Condition.code
AdverseEvent.event	AdverseEvent.event
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
Medical History Occurrence	MHOCCUR	MHOCCUR	Condition.verificationStatus	Condition.verificationStatus.where(%this IN {'refuted'\|'entered-in-error'})	In general in FHIR, records of the absence of Conditions are not normally captured. If the information revolves around "has the patient had X", that would be accomplished through a Questionnaire.Response
AllergyIntolerance.verificationStatus	(AllergyIntolerance.verificationStatus in {'unconfirmed'\|'confirmed'\|'refuted'\|'entered-in-error'}).not()
Observation.effectiveDateTime	Observation.effectiveDateTime
Medical History Event Prespecified	MHPRESP	MHPRESP	Not expect to receive these from the site. How this is populated in the sponsor's database would be up to the sponsor. If available, this would need to be an extension. The notion of pre-specified is part of the questionnaire
Prior Medical History Event	MHPRIOR	MHSTRTPT; MHSTRF	This can be determined from either the onsetDateTime and/or the abatementDateTime. If it were to be flagged on the record, it would need to be an extension on the extension that links to the study. The sponsor may determine this, based on an anchor point in the protocol.
Ongoing Medical History Event	MHONGO	MHENRF; MHENRTPT	Condition.clinicalStatus	Condition.clinicalStatus
AdverseEvent.outcome	AdverseEvent.outcome
Medical History Event Start Date	MHSTDAT	MHSTDTC	Condition.onsetDateTime	Condition.onset.onsetDateTime
AdverseEvent.date	AdverseEvent.date
AllergyIntolerance.onsetDateTime	AllergyIntolerance.onsetDateTime
Observation.effectiveDateTime	Observation.effectiveDateTime
Medical History Event End Date	MHENDAT	MHENDTC	Condition.abatementDateTime	Condition.abatementDateTime
Medical History Event Location	MHLOC	MHLOC	Condition.bodySite	Condition.bodysite
Condition.bodySite	AdverseEvent.resultingCondition.resolve().bodySite
Observation.bodySite	Observation.bodySite Observation.specimen.resolve().bodySite
Specimen.bodySite	Observation.bodySite Observation.specimen.resolve().bodySite
Medical History Event Laterality	MHLAT	MHLAT	There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure.
Medical History Directionality	MHDIR	MHDIR	There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure.
MH Event Location Portion or Totality	MHPORTOT	MHPORTOT	This would likely be an extension on Condition
MH Modified Reported Term	MHMODIFY	MHMODIFY	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Dictionary-Derived Term	MHDECOD	MHDECOD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
Medical History Event Lowest Level Term	MHLLT	MHLLT	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event Lowest Level Term Code	MHLLTCD	MHLLTCD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event Preferred Term Code	MHPTCD	MHPTCD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
Medical History High Level Term	MHHLT	MHHLT	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event High Level Term Code	MHHLTCD	MHHLTCD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event High Level Group Term	MHHLGT	MHHLGT	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event High Level Group Term Code	MHHLGTCD	MHHLGTCD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event Primary System Organ Class	MHSOCCD	MHSCOC	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code
MH Event Primary System Organ Class Code	MHSOCCD	MHSOCCD	Condition.code	Condition.code	Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code
AdverseEvent.code	AdverseEvent.code
AllergyIntolerance.code	AllergyIntolerance.code
Observation.code	Observation.code

CDISC

FHIR map (or gap)

Comment

Name

CDASH

SDTM

Element

FHIRPath

Study ID or Number

STUDYID

ResearchStudy.identifier

ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().partOf.resolve().identifier.value

AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value

Condition.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value

AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value

Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value

Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy.

The path using the extension will only exist if the system maintaining the AdverseEvent/Condition/AllergyIntolerance/Observation is aware of its relevance to the Study.

Study Site ID

SITEID

DM.SITEID

ResearchStudy.site

ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().identifier.value

AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().identifier.value

Condition.extension(workflow-researchstudy).valueReference.resolve().identifier.value

AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().identifier.value

Observation.extension(workflow-researchstudy).valueReference.resolve().identifier.value

Subject ID for the Study

SUBJID

DM.SUBJID

ResearchSubject.identifier

ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject)).identifer.value

Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the focal resource.

No standard way to decide which subject identifier to use

Any Medical History Event

MHYN

If captured, this would be a Questionnaire question. FHIR almost always has some type of history information. Will require review to determine if the history is relevant.

Category for Medical History

MHCAT

Condition.category

The sponsors does not typically require this information from the sites.

If needed there are several options to categorize this based on whether something is a Condition/AllergyIntolerance/Observation/etc. This could also include sub-categorize by diagnosis vs. problem, Allergy vs. intolerance or use Observation.category. But in general, the mapping to both CAT and SCAT is going to be driven by what types of categories the study requires or needs.

AdverseEvent.category

AllergyIntolerance.category

Observation.category

Subcategory for Medical History

MHSCAT

Condition.category

AdverseEvent.category

AllergyIntolerance.category

Observation.category

Medical History Collection Date

MHDAT

Condition.recordedDate

AdverseEvent.recordedDate

AllergyIntolerance.recordedDate

Observation.effectiveDteTime

Observaton.effectiveDateTime

MH Sponsor Defined Identifier

MHSPID

Condition.identifier

If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping.

AdverseEvent.identifier

AllergyIntolerance.identifier

AlergyIntolerance.identifier

Observation.identifier

Medical History Event Date Type

MHEVDTYP

SUPPMH.QVAL

Condition.onset

AdverseEvent.date

AllergyIntolerance.onsetDateTime

AllergyIntolerance.onsetRange

AllergyIntolerance.onsetString

Observation.effectiveDateTime

Observation.effectivePeriod

Observation.effectiveTiming

Observation.effectiveInstant

Observaton.effectiveInstant

Reported Term for Medical History

MHTERM

Condition.code

AdverseEvent.event

AllergyIntolerance.code

Observation.code

Medical History Occurrence

MHOCCUR

Condition.verificationStatus

Condition.verificationStatus.where(%this IN {'refuted'|'entered-in-error'})

In general in FHIR, records of the absence of Conditions are not normally captured. If the information revolves around "has the patient had X", that would be accomplished through a Questionnaire.Response

AllergyIntolerance.verificationStatus

(AllergyIntolerance.verificationStatus in {'unconfirmed'|'confirmed'|'refuted'|'entered-in-error'}).not()

Observation.effectiveDateTime

Medical History Event Prespecified

MHPRESP

Not expect to receive these from the site. How this is populated in the sponsor's database would be up to the sponsor. If available, this would need to be an extension. The notion of pre-specified is part of the questionnaire

Prior Medical History Event

MHPRIOR

MHSTRTPT; MHSTRF

This can be determined from either the onsetDateTime and/or the abatementDateTime. If it were to be flagged on the record, it would need to be an extension on the extension that links to the study.

The sponsor may determine this, based on an anchor point in the protocol.

Ongoing Medical History Event

MHONGO

MHENRF; MHENRTPT

Condition.clinicalStatus

AdverseEvent.outcome

Medical History Event Start Date

MHSTDAT

MHSTDTC

Condition.onsetDateTime

Condition.onset.onsetDateTime

AdverseEvent.date

AllergyIntolerance.onsetDateTime

Observation.effectiveDateTime

Medical History Event End Date

MHENDAT

MHENDTC

Condition.abatementDateTime

Medical History Event Location

MHLOC

Condition.bodySite

Condition.bodysite

Condition.bodySite

AdverseEvent.resultingCondition.resolve().bodySite

Observation.bodySite

Observation.specimen.resolve().bodySite

Specimen.bodySite

Observation.bodySite

Observation.specimen.resolve().bodySite

Medical History Event Laterality

MHLAT

There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure.

Medical History Directionality

MHDIR

There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure.

MH Event Location Portion or Totality

MHPORTOT

This would likely be an extension on Condition

MH Modified Reported Term

MHMODIFY

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Dictionary-Derived Term

MHDECOD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

Medical History Event Lowest Level Term

MHLLT

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event Lowest Level Term Code

MHLLTCD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event Preferred Term Code

MHPTCD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

Medical History High Level Term

MHHLT

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event High Level Term Code

MHHLTCD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event High Level Group Term

MHHLGT

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event High Level Group Term Code

MHHLGTCD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event Primary System Organ Class

MHSOCCD

MHSCOC

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code

MH Event Primary System Organ Class Code

MHSOCCD

Condition.code

Condition.code can have numerous coding all with varying levels of granularity. The type of granularity is conveyed either by the code system or knowledge of the code

AdverseEvent.code

AllergyIntolerance.code

Observation.code