FHIR to CDISC Joint Mapping Implementation Guide
1.0.0 - STU 1
FHIR to CDISC Joint Mapping Implementation Guide
1.0.0 - STU 1
FHIR to CDISC Joint Mapping Implementation Guide, published by HL7 International - BR&R Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-cdisc-mapping/ and changes regularly. See the Directory of published versions
Medical history could include information from a wide range of FHIR resources. However, the most typical resources are:
Mappings are provided for all of these.
Guidance on interpreting the tables can be found here.
| CDISC | FHIR map (or gap) | Comment | |||
|---|---|---|---|---|---|
| Label | CDASH | SDTM | Element | FHIRPath | |
| Study Identifier |
STUDYID
Core: HR Type: Char |
STUDYID
Core: Req Type: Char |
ResearchStudy.identifier
0..* Identifier |
ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().partOf.resolve().identifier AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier Condition.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier |
Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. ResearchStudy links to Patient. Observation links to Patient. If the patients are the same, that establishes the linkage. There's also an extension that allows direct linkage to a 'study' from any resource - if the source system has actually established such a linkage. |
| Study Site Identifier |
SITEID
Core: HR Type: Char |
DM.SITEID
Core: Req Type: Char |
ResearchStudy.site
0..* Reference |
ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().identifier AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().identifier Condition.extension(workflow-researchstudy).valueReference.resolve().identifier AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().identifier |
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 Identifier for the Study |
SUBJID
Core: HR Type: Char |
DM.SUBJID
Core: Req Type: Char |
ResearchSubject.identifier
0..* 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
Core: O Type: Char |
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
Core: R/C Type: Char |
MHCAT
Core: Perm Type: Char |
Condition.category
0..* CodeableConcept Binding: ConditionCategory extensible |
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
0..* CodeableConcept Binding: AdverseEventCategory extensible |
AdverseEvent.category |
||||
|
AllergyIntolerance.category
0..* code Binding: AllergyIntoleranceCategory required |
AllergyIntolerance.category |
||||
|
Observation.category
0..* CodeableConcept Binding: ObservationCategory preferred |
Observation.category |
||||
| Subcategory for Medical History |
MHSCAT
Core: O Type: Char |
MHSCAT
Core: Perm Type: Char |
Condition.category
0..* CodeableConcept Binding: ConditionCategory extensible |
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
0..* CodeableConcept Binding: AdverseEventCategory extensible |
AdverseEvent.category |
||||
|
AllergyIntolerance.category
0..* code Binding: AllergyIntoleranceCategory required |
AllergyIntolerance.category |
||||
|
Observation.category
0..* CodeableConcept Binding: ObservationCategory preferred |
Observation.category |
||||
| Medical History Collection Date |
MHDAT
Core: O Type: Char |
MHDTC
Core: Perm Type: Char values: ISO 8601 |
Condition.recordedDate
0..1 dateTime |
Condition.recordedDate |
|
|
AdverseEvent.recordedDate
0..1 dateTime |
AdverseEvent.recordedDate |
||||
|
AllergyIntolerance.recordedDate
0..1 dateTime |
AllergyIntolerance.recordedDate |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observaton.effectiveDateTime |
||||
| MH Sponsor-Defined Identifier |
MHSPID
Core: O Type: Char |
MHSPID
Core: Perm Type: Char |
Condition.identifier
0..* 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
0..1 Identifier |
AdverseEvent.identifier |
||||
|
AllergyIntolerance.identifier
0..* Identifier |
AlergyIntolerance.identifier |
||||
|
Observation.identifier
0..* Identifier |
Observation.identifier |
||||
| Medical History Event Date Type |
MHEVDTYP
Core: O Type: Char |
SUPPMH.QVAL | If MHSTDTC and/or the MHENDTC are extracted from FHIR, their meaning is fixed, and thus so will be the value of this element. | This will generally be set to SYMPTOM ONSET for all resources, as both the onsetDateTime and effectiveDateTime are expected to represent when the symptoms first appeared, not when the diagnosis occurred. However, there are no strict rules in FHIR about when a condition flare-up is considered to be a continuation of a prior condition and when it's a new condition. Thus in some cases, new condition instances could spawn from net new episodes or relapes. Spronsors may need to check for prior condition instances and based on their rules, adjust the value for this field to be EPISODE or something else in some cases. | |
| Reported Term for the Medical History |
MHTERM
Core: HR Type: Char |
MHTERM
Core: Req Type: Char |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code |
|
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code |
||||
| Medical History Occurrence |
MHOCCUR
Core: O Type: Char |
MHOCCUR
Core: Perm Type: Char |
Condition.verificationStatus
0..1 CodeableConcept con-3, con-5 Binding: ConditionVerificationStatus required |
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
0..1 CodeableConcept ait-1, ait-2 Binding: AllergyIntoleranceVerificationStatus required |
(AllergyIntolerance.verificationStatus in {'unconfirmed'|'confirmed'|'refuted'|'entered-in-error'}).not() |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observation.effectiveDateTime |
||||
| Medical History Event prespecified |
MHPRESP
Core: O Type: Char |
MHPRESP
Core: Perm Type: Char |
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
Core: O Type: Char |
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
Core: O Type: Char |
MHENRF
Core: Perm Type: Char MHENRTPT Core: Perm Type: Char values: AFTER, BEFORE, COINCIDENT, ONGOING, U |
Condition.clinicalStatus
0..1 CodeableConcept con-3, con-4, con-5 Binding: ConditionClinicalStatus required |
Condition.clinicalStatus |
|
|
AdverseEvent.outcome
0..1 CodeableConcept Binding: AdverseEventOutcome required |
AdverseEvent.outcome |
||||
| MH Disease or Symptom Under Control |
MHCTRL
Core: O Type: Char |
Condition.clinicalStatus
0..1 CodeableConcept con-3, con-4, con-5 Binding: ConditionClinicalStatus required |
Condition.clinicalStatus = ('inactive','remission',resolved') |
For all of these, the evaluation of resolution is tied to the date the record was last updated, not necessarily the start of the study, so lack of resolution in the record doesn't necessarily mean that the item will be unresolved at study time. | |
|
AdverseEvent.outcome
0..1 CodeableConcept Binding: AdverseEventOutcome required |
Observation.outcome = ('resolved', 'resolvedWithSequelae') |
||||
|
AllergyIntolerance.clinicalStatus
0..1 CodeableConcept ait-1, ait-2 Binding: AllergyIntoleranceClinicalStatus required |
AllergyIntolerance.clinicalStatus = ('inactive', 'resolved') |
||||
| Medical History Event Start Date |
MHSTDAT
Core: O Type: Char |
MHSTDTC
Core: Perm Type: Char values: ISO 8601 |
Condition.onsetDateTime
0..1 dateTime |
Condition.onset.onsetDateTime |
|
|
AdverseEvent.date
0..1 dateTime |
AdverseEvent.date |
||||
|
AllergyIntolerance.onsetDateTime
0..1 dateTime |
AllergyIntolerance.onsetDateTime |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observation.effectiveDateTime |
||||
| Medical History Event End Date |
MHENDAT
Core: O Type: Char |
MHENDTC
Core: Perm Type: Char values: ISO 8601 |
Condition.abatementDateTime
0..1 dateTime con-4 |
Condition.abatementDateTime |
|
| Medical History Event Location |
MHLOC
Core: O Type: Char |
MHLOC* |
Condition.bodySite
0..* CodeableConcept Binding: BodySite example |
Condition.bodysite |
AllergyIntolerances are generally not associated with body sites. |
|
Condition.bodySite
0..* CodeableConcept Binding: BodySite example |
AdverseEvent.resultingCondition.resolve().bodySite |
||||
|
Observation.bodySite
0..1 CodeableConcept Binding: BodySite example |
Observation.bodySite Observation.specimen.resolve().collection.bodySite |
||||
|
Specimen.collection.bodySite
0..1 CodeableConcept Binding: BodySite example |
Observation.bodySite Observation.specimen.resolve().collection.bodySite |
||||
| Medical History Event Laterality |
MHLAT
Core: O Type: Char |
MHLAT* | There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure. Laterality is not relevant for allergies. Differentiation of laterality, directionality and other location qualifiers will require knowledge of the qualifier codes and code-by-code mapping | ||
| Medical History Directionality |
MHDIR
Core: O Type: Char |
MHDIR* | There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure. Directionality is not relevant for allergies. Differentiation of laterality, directionality and other location qualifiers will require knowledge of the qualifier codes and code-by-code mapping | ||
| MH Event Location Portion or Totality |
MHPORTOT
Core: O Type: Char |
MHPORTOT* | This would likely be an extension on Condition. It is not relevant for the other resources | ||
| MH Modified Reported Term |
MHMODIFY
Core: O Type: Char |
MHMODIFY
Core: Perm Type: Char |
This would need to be captured as an extension on AdverseEvent.event.text. A new standard extesnsion should be proposed | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. | |
| MH Dictionary-Derived Term |
MHDECOD
Core: O Type: Char |
MHDECOD
Core: Perm Type: Char |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHDECOD).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHDECOD).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHDECOD).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHDECOD).code |
||||
| Medical History Event Lowest Level Term |
MHLLT
Core: O Type: Char |
MHLLT* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHLLT).display |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHLLT).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHLLT).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHLLT).display |
||||
| MH Event Lowest Level Term Code |
MHLLTCD
Core: O Type: Num |
MHLLTCD* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHLLT).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHLLT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHLLT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHLLT).code |
||||
| MH Event Preferred Term Code |
MHPTCD
Core: O Type: Num |
MHPTCD* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHPT).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHPT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHPT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHPT).code |
||||
| Medical History Event High Level Term |
MHHLT
Core: O Type: Char |
MHHLT* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.where(system=%MHHLT).display |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLT).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.where(system=%MHHLT).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.where(system=%MHHLT).display |
||||
| MH Event High Level Term Code |
MHHLTCD
Core: O Type: Num |
MHHLTCD* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLT).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLT).code |
||||
| MH Event High Level Group Term |
MHHLGT
Core: O Type: Char |
MHHLGT* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).display |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).display |
||||
| MH Event High Level Group Term Code |
MHHLGTCD
Core: O Type: Num |
MHHLGTCD* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).code |
||||
| MH Event Primary System Organ Class | MHSCOC* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. | |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).code |
||||
| MH Event Primary System Organ Class Code |
MHSOCCD
Core: O Type: Num |
MHSOCCD* |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHSOC).code |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHSOC).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHSOC).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHSOC).code |
||||
| FHIR map (or gap) | CDISC | Comment | |||
|---|---|---|---|---|---|
| Label | Element | FHIRPath | CDASH | SDTM | |
| Study Identifier |
ResearchStudy.identifier
0..* Identifier |
ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().partOf.resolve().identifier AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier Condition.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier |
STUDYID
Core: HR Type: Char |
STUDYID
Core: Req Type: Char |
Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. ResearchStudy links to Patient. Observation links to Patient. If the patients are the same, that establishes the linkage. There's also an extension that allows direct linkage to a 'study' from any resource - if the source system has actually established such a linkage. |
| Study Site Identifier |
ResearchStudy.site
0..* Reference |
ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject).study.resolve().identifier AdverseEvent.extension(workflow-researchstudy).valueReference.resolve().identifier Condition.extension(workflow-researchstudy).valueReference.resolve().identifier AllergyIntolerance.extension(workflow-researchstudy).valueReference.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().identifier |
SITEID
Core: HR Type: Char |
DM.SITEID
Core: Req Type: Char |
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 Identifier for the Study |
ResearchSubject.identifier
0..* Identifier |
ResearchSubject.where(individual=(AdverseEvent.subject|Condition.subject|AllergyIntolerance.patient|Observation.subject)).identifer.value |
SUBJID
Core: HR Type: Char |
DM.SUBJID
Core: Req Type: Char |
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 | 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. |
MHYN
Core: O Type: Char |
|||
| Category for Medical History |
Condition.category
0..* CodeableConcept Binding: ConditionCategory extensible |
Condition.category |
MHCAT
Core: R/C Type: Char |
MHCAT
Core: Perm Type: Char |
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
0..* CodeableConcept Binding: AdverseEventCategory extensible |
AdverseEvent.category |
||||
|
AllergyIntolerance.category
0..* code Binding: AllergyIntoleranceCategory required |
AllergyIntolerance.category |
||||
|
Observation.category
0..* CodeableConcept Binding: ObservationCategory preferred |
Observation.category |
||||
| Subcategory for Medical History |
Condition.category
0..* CodeableConcept Binding: ConditionCategory extensible |
Condition.category |
MHSCAT
Core: O Type: Char |
MHSCAT
Core: Perm Type: Char |
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
0..* CodeableConcept Binding: AdverseEventCategory extensible |
AdverseEvent.category |
||||
|
AllergyIntolerance.category
0..* code Binding: AllergyIntoleranceCategory required |
AllergyIntolerance.category |
||||
|
Observation.category
0..* CodeableConcept Binding: ObservationCategory preferred |
Observation.category |
||||
| Medical History Collection Date |
Condition.recordedDate
0..1 dateTime |
Condition.recordedDate |
MHDAT
Core: O Type: Char |
MHDTC
Core: Perm Type: Char values: ISO 8601 |
|
|
AdverseEvent.recordedDate
0..1 dateTime |
AdverseEvent.recordedDate |
||||
|
AllergyIntolerance.recordedDate
0..1 dateTime |
AllergyIntolerance.recordedDate |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observaton.effectiveDateTime |
||||
| MH Sponsor-Defined Identifier |
Condition.identifier
0..* Identifier |
Condition.identifier |
MHSPID
Core: O Type: Char |
MHSPID
Core: Perm Type: Char |
If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping. |
|
AdverseEvent.identifier
0..1 Identifier |
AdverseEvent.identifier |
||||
|
AllergyIntolerance.identifier
0..* Identifier |
AlergyIntolerance.identifier |
||||
|
Observation.identifier
0..* Identifier |
Observation.identifier |
||||
| Medical History Event Date Type | If MHSTDTC and/or the MHENDTC are extracted from FHIR, their meaning is fixed, and thus so will be the value of this element. |
MHEVDTYP
Core: O Type: Char |
SUPPMH.QVAL | This will generally be set to SYMPTOM ONSET for all resources, as both the onsetDateTime and effectiveDateTime are expected to represent when the symptoms first appeared, not when the diagnosis occurred. However, there are no strict rules in FHIR about when a condition flare-up is considered to be a continuation of a prior condition and when it's a new condition. Thus in some cases, new condition instances could spawn from net new episodes or relapes. Spronsors may need to check for prior condition instances and based on their rules, adjust the value for this field to be EPISODE or something else in some cases. | |
| Reported Term for the Medical History |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code |
MHTERM
Core: HR Type: Char |
MHTERM
Core: Req Type: Char |
|
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code |
||||
| Medical History Occurrence |
Condition.verificationStatus
0..1 CodeableConcept con-3, con-5 Binding: ConditionVerificationStatus required |
Condition.verificationStatus.where(%this IN {'refuted'|'entered-in-error'}) |
MHOCCUR
Core: O Type: Char |
MHOCCUR
Core: Perm Type: Char |
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
0..1 CodeableConcept ait-1, ait-2 Binding: AllergyIntoleranceVerificationStatus required |
(AllergyIntolerance.verificationStatus in {'unconfirmed'|'confirmed'|'refuted'|'entered-in-error'}).not() |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observation.effectiveDateTime |
||||
| Medical History Event prespecified | 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 |
MHPRESP
Core: O Type: Char |
MHPRESP
Core: Perm Type: Char |
||
| Prior Medical History Event | 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. |
MHPRIOR
Core: O Type: Char |
MHSTRTPT* MHSTRF* | ||
| Ongoing Medical History Event |
Condition.clinicalStatus
0..1 CodeableConcept con-3, con-4, con-5 Binding: ConditionClinicalStatus required |
Condition.clinicalStatus |
MHONGO
Core: O Type: Char |
MHENRF
Core: Perm Type: Char MHENRTPT Core: Perm Type: Char values: AFTER, BEFORE, COINCIDENT, ONGOING, U |
|
|
AdverseEvent.outcome
0..1 CodeableConcept Binding: AdverseEventOutcome required |
AdverseEvent.outcome |
||||
| MH Disease or Symptom Under Control |
Condition.clinicalStatus
0..1 CodeableConcept con-3, con-4, con-5 Binding: ConditionClinicalStatus required |
Condition.clinicalStatus = ('inactive','remission',resolved') |
MHCTRL
Core: O Type: Char |
For all of these, the evaluation of resolution is tied to the date the record was last updated, not necessarily the start of the study, so lack of resolution in the record doesn't necessarily mean that the item will be unresolved at study time. | |
|
AdverseEvent.outcome
0..1 CodeableConcept Binding: AdverseEventOutcome required |
Observation.outcome = ('resolved', 'resolvedWithSequelae') |
||||
|
AllergyIntolerance.clinicalStatus
0..1 CodeableConcept ait-1, ait-2 Binding: AllergyIntoleranceClinicalStatus required |
AllergyIntolerance.clinicalStatus = ('inactive', 'resolved') |
||||
| Medical History Event Start Date |
Condition.onsetDateTime
0..1 dateTime |
Condition.onset.onsetDateTime |
MHSTDAT
Core: O Type: Char |
MHSTDTC
Core: Perm Type: Char values: ISO 8601 |
|
|
AdverseEvent.date
0..1 dateTime |
AdverseEvent.date |
||||
|
AllergyIntolerance.onsetDateTime
0..1 dateTime |
AllergyIntolerance.onsetDateTime |
||||
|
Observation.effectiveDateTime
0..1 dateTime |
Observation.effectiveDateTime |
||||
| Medical History Event End Date |
Condition.abatementDateTime
0..1 dateTime con-4 |
Condition.abatementDateTime |
MHENDAT
Core: O Type: Char |
MHENDTC
Core: Perm Type: Char values: ISO 8601 |
|
| Medical History Event Location |
Condition.bodySite
0..* CodeableConcept Binding: BodySite example |
Condition.bodysite |
MHLOC
Core: O Type: Char |
MHLOC* | AllergyIntolerances are generally not associated with body sites. |
|
Condition.bodySite
0..* CodeableConcept Binding: BodySite example |
AdverseEvent.resultingCondition.resolve().bodySite |
||||
|
Observation.bodySite
0..1 CodeableConcept Binding: BodySite example |
Observation.bodySite Observation.specimen.resolve().collection.bodySite |
||||
|
Specimen.collection.bodySite
0..1 CodeableConcept Binding: BodySite example |
Observation.bodySite Observation.specimen.resolve().collection.bodySite |
||||
| Medical History Event Laterality | There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure. Laterality is not relevant for allergies. Differentiation of laterality, directionality and other location qualifiers will require knowledge of the qualifier codes and code-by-code mapping |
MHLAT
Core: O Type: Char |
MHLAT* | ||
| Medical History Directionality | There should be a standard extension defined that allows Condition, AdverseEvent, Observation and Specimen to point to a BodyStructure. Directionality is not relevant for allergies. Differentiation of laterality, directionality and other location qualifiers will require knowledge of the qualifier codes and code-by-code mapping |
MHDIR
Core: O Type: Char |
MHDIR* | ||
| MH Event Location Portion or Totality | This would likely be an extension on Condition. It is not relevant for the other resources |
MHPORTOT
Core: O Type: Char |
MHPORTOT* | ||
| MH Modified Reported Term | This would need to be captured as an extension on AdverseEvent.event.text. A new standard extesnsion should be proposed |
MHMODIFY
Core: O Type: Char |
MHMODIFY
Core: Perm Type: Char |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. | |
| MH Dictionary-Derived Term |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHDECOD).code |
MHDECOD
Core: O Type: Char |
MHDECOD
Core: Perm Type: Char |
In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHDECOD).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHDECOD).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHDECOD).code |
||||
| Medical History Event Lowest Level Term |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHLLT).display |
MHLLT
Core: O Type: Char |
MHLLT* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHLLT).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHLLT).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHLLT).display |
||||
| MH Event Lowest Level Term Code |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHLLT).code |
MHLLTCD
Core: O Type: Num |
MHLLTCD* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHLLT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHLLT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHLLT).code |
||||
| MH Event Preferred Term Code |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHPT).code |
MHPTCD
Core: O Type: Num |
MHPTCD* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHPT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHPT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHPT).code |
||||
| Medical History Event High Level Term |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.where(system=%MHHLT).display |
MHHLT
Core: O Type: Char |
MHHLT* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLT).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.where(system=%MHHLT).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.where(system=%MHHLT).display |
||||
| MH Event High Level Term Code |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLT).code |
MHHLTCD
Core: O Type: Num |
MHHLTCD* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLT).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLT).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLT).code |
||||
| MH Event High Level Group Term |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).display |
MHHLGT
Core: O Type: Char |
MHHLGT* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).display |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).display |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).display |
||||
| MH Event High Level Group Term Code |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).code |
MHHLGTCD
Core: O Type: Num |
MHHLGTCD* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).code |
||||
| MH Event Primary System Organ Class |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHHLG).code |
MHSCOC* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. | |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHHLG).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHHLG).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHHLG).code |
||||
| MH Event Primary System Organ Class Code |
Condition.code
0..1 CodeableConcept Binding: ConditionKind example |
Condition.code.coding.where(system=%MHSOC).code |
MHSOCCD
Core: O Type: Num |
MHSOCCD* | In most cases, no MedDRA codes will be present in source data and all coding levels and displays will be added by the sponsor. However, FHIR allows multiple codings and therefore all of these codes *can* be conveyed in FHIR if the data source chooses to capture them. Standard code system URLs should be defined for each of the MedDRA levels. If MedDRA is considered a single code system, then the consumer will be responsible for distinguishing which codes represent which levels by looking up the received code. |
|
AdverseEvent.event
0..1 CodeableConcept Binding: AdverseEventType example |
AdverseEvent.event.coding.where(system=%MHSOC).code |
||||
|
AllergyIntolerance.code
0..1 CodeableConcept Binding: AllergyIntoleranceCode example |
AllergyIntolerance.code.coding.where(system=%MHSOC).code |
||||
|
Observation.code
1..1 CodeableConcept Binding: ObservationCode example |
Observation.code.coding.where(system=%MHSOC).code |
||||
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.uv.cdisc-mapping#1.0.0 based on FHIR 4.0.1. Generated 2024-07-29
Links: Table of Contents |
QA Report
| Version History |
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