HL7.FHIR.UV.CDISC-MAPPING\Laboratory

This page is part of the CDISC Mapping FHIR IG (v1.0.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Laboratory

Contents:

LB Mappings
LAB Mappings

This domain contains two mapping tables. The first is similar to the other domains and covers the SDTM and CDASH specification. The second covers the CDISC LAB specification. It is handled as a separate table because it has a significantly larger number of data elements than the other two specifications and the element names have less correlation. Readability of the mappings was enhanced by moving the content to a separate specification.

Lab data in FHIR is handled by two primary resources:

DiagnosticReport which covers the overall report of a collection of lab reports
Observation which handles the individual data measurements within an overall lab report

The CDISC specifications focus almost exclusively on the latter. As a result, mappings in both tables are expressed from the perspective of an Observation-rooted transformation. (I.e. All paths are rooted in Observation or are driven by a search based on Observation.) For studies interested in the retrieval of legacy lab information, it may in some cases be necessary to retrieve the DiagnosticReport and manually extract information from a PDF or other report representation. Obviously no standardized mapping can be provided here to assist with that.

In FHIR, the Observation resource is used for a wide range of data collection purposes. In addition to lab data, it is also used to capture vital signs, patient symptoms, psychological assessments, device data, and others. Ideally, lab data can be distinguished from types of Observations using the Observation.category element which should, ideally, have a code of laboratory drawn from the http://terminology.hl7.org/CodeSystem/observation-category. However, the core FHIR specification does not mandate the use of this code or system. (The U.S. Realm implementation guide and several other national implementation guides do mandate the use of this category.)

The 'laboratory' category encompasses both simple chemical measurements as well as complex assessments including the description of genetic variants, microbiology tests, etc. This implementation guide focuses only on simple measurements and does not attempt to map more complex structures - which in some cases correspond to distinct CDISC domains. In part, this is because FHIR has not yet tried to enforce standardized representation of more complex areas, though initial work has been completed on the capture of genetic findings. Future versions of this implementation guide will likely tackle more complex lab structures.

LB Mappings

Guidance on interpreting the tables can be found here.

CDISC Lookup view
FHIR mapping view

CDISC	FHIR map (or gap)	Comment
Study Identifier	DM.STUDYID Core: HR Type: Char	DM.STUDYID Core: Req Type: Char	ResearchStudy.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.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. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study. 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	DM.SITEID Core: HR Type: Char	DM.SITEID Core: Req Type: Char	ResearchStudy.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.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 Observation is aware of its relevance to the Study.
Investigator Identifier		DM.INVID Core: Perm Type: Char	Practitioner.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().identifier	Will need to decide which id to expose. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Subject Identifier for the Study	DM.SUBJID Core: HR Type: Char	DM.SUBJID Core: Req Type: Char	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(individual=Observation.subject).identifier	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. No standard way to decide which subject identifier to use
Visit Number	VISITNUM	VISITNUM Core: Exp Type: Num	Encounter.identifier 0..* Identifier	Observation.encounter.resolve().identifier	This won't necessarily correlate with the protocol-defined visit number. Correspondance to a protocol-defined visit will typically require rules-based analysis based on time, encounter type and other factors.
Visit Name	VISIT Core: R/C Type: Char	VISIT Core: Perm Type: Char	ActivityDefinition.name 0..1 string inv-0	Observation.encounter.resolve().extension(workflow-instantiates).valueCanonical.resolve().title	In most cases, real world data won't have a direct association to a study protocol activity and the link would need to be inferred. However, if it exists, it would map as follows: We could go through Encounter.basedOn-> ServiceRequest.instantiatesCanonical, you arrive at ActivityDefinition. Encounter should have a standard instantiatesCanonical extension that would allow pointing to the ActivityDefinition. This would be the ActivityDefinition.name. Submit a change request to add the extension
Lab Specimen ID	LBREFID Core: R/C Type: Char	LBREFID Core: Perm Type: Char	Specimen.accessionIdentifier 0..1 Identifier	Observation.specimen.resolve().accessionIdentifier	As reported from the Site
Date/Time of Specimen Collection		LBDTC Core: Exp Type: Char values: ISO 8601	Specimen.collection.collectedDateTime 0..1 dateTime	Observation.specimen.resolve().collection.collectedDateTime	NOTE: no mapping included for CDASH LBDAT and LBTIM To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)
Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.start
End Date/Time of Specimen Collection		LBENDTC Core: Perm Type: Char values: ISO 8601	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end	NOTE: No mapping included for CDASH LBENDAT and LBENTIM) To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)
Specimen Collection Duration (for Clinical Research with extended time of collection)	LBCDUR	LBDUR*	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod	Will need to convert value and unit to ISO syntax. E.g. 90 min would convert to PT1H30M
Specimen Planned Time Point Name (Planned Collection Time Point - time within Encounter)	LBCTPT	LBTPT Core: Perm Type: Char	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('reference').valueReference.reference.resolve().title	Typically named timepoints won't exist in real-world data and the timing point name will need to be assigned by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there.
Specimen Planned Elapsed Time from Time Point Reference	LBCELTM	LBELTM Core: Perm Type: Char values: ISO 8601	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('offset').valueDuration	Typically named timepoints won't exist in real-world data and the timing point offset will need to be calculated by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there. If present, would need to translate to ISO-8601
Specimen Condition	LBCSPCCN	LBSPCCND Core: Perm Type: Char	Specimen.condition 0..* CodeableConcept Binding: SpecimenCondition extensible	Observation.specimen.resolve().condition.coding.code	Recommend submitting change proposals to extend the FHIR vocabulary to include CDISC values. Sponsor will need to decide how to map when FHIR terminology contains codes not present in CDISC. NOTE: requires an extension to the FHIR vocabulary to include CDISC values (e.g., Refrigerated). An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.
Specimen Type	LBCSPEC	LBSPEC Core: Perm Type: Char	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().type.coding.display	NOTE: In some cases, this may be inferred from the LOINC. FHIR terminology is not standardized. Sponsor will need to map to CDISC terminology if raw data does not use CDISC codes. An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.
Fasting Status	LBCFAST	LBFAST Core: Perm Type: Char	Specimen.collection.fastingStatusCodeableConcept 0..1 CodeableConcept Binding: FastingStatus extensible	Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code	FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable. If fastingStatusDuration is present and non-zero, that would also map to 'Y'. In some cases, this may be inferred from the LOINC term (Challenge). For example, Challenge=post CFst to signify a calorie fast.
Lab Test Condition Met	LBCOND Core: R/C Type: Char		This is an 'ask on entry' question. May be able to determine some conditions, such as fasting, by using other specimen.collection attributes (e.g., fasting status). Others might be captured as components or extensions. Alternatively, obtain this information from the case report form entries.	There are explicit elements for Specimen.collection.fastingStatus and collection.fastingDuration. May need extensions for other pre-conditions
Specimen Collection Position	LBCPOS	LBPOS*	Specimen.collection 0..1 BackboneElement	Observation.specimen.resolve().collection.extension(observation-bodyPosition).valueCodeableConcept	As reported from the lab. Will need to map to CDISC controlled terminology
Specimen Usability for the Test	LBCSPCUF	LBSPCUFL*	Specimen.status 0..1 code Binding: SpecimenStatus required	Observation.specimen.resolve()status.where($this='Unsatisfactory')	Need to translate to blank or N if not received as blank or N May not be applicable for safety labs.
Category	LBCCAT	LBCAT Core: Exp Type: Char	DiagnosticReport.category 0..* CodeableConcept Binding: DiagnosticServiceSection example	DiagnosticReport.category.coding.where(system='LBSCAT').code	NOTE: In some cases, this may be inferred from the LOINC. It might also be found by looking for the 'panel' Obsesrvation this Observation is a part of. In most cases, translation will be required to sponsor-defined codes. It may work best for the sponsor to categorize based on TESTCD values and ignore lab-reported and EHR-determined categories entirely.
DiagnosticReport.code 1..1 CodeableConcept Binding: DiagnosticReportCodes preferred	DiagnosticReport.code
Test Status	LBCSTAT	LBSTAT Core: Perm Type: Char	ServiceRequest.doNotPerform 0..1 boolean	Observation.basedOn.resolve().doNotPerform	Sponsor may choose to map a situation in which the entire panel is cancelled as one summary record compliant with SDTM IG examples. Some sponsor may decline to accept cancelled records under specific circumstances (e.g., unscheduled) Sponsor may also choose to populate LBREASND as CANCELLED Needs to be translated from FHIR vocabulary to SDTM controlled terminology: FHIR -> CDISC: Not performed = NOT DONE Cancelled = NOT DONE Completed = <blank>
ServiceRequest.status 1..1 code Binding: ServiceRequestStatus required	Observation.basedOn.resolve().status
Reason Test Not Done		LBREASND Core: Perm Type: Char	Observation.dataAbsentReason 0..1 CodeableConcept obs-6 Binding: ObservationValueAbsentReason extensible	Observation.dataAbsentReason.text	see notes on LBSTAT
Lab Test or Examination Short Name		LBTESTCD Core: Req Type: Char	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(selected=true).code	Translate to compliant terminology (if needed)
Lab Test or Examination Name		LBTEST Core: Req Type: Char	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(selected=true).display	Translate to compliant terminology (if needed)
Test LOINC Code	LBLOINC	LBLOINC Core: Perm Type: Char	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system='http://loinc.org').code
Vendor Name	LBNAM Core: R/C Type: Char	LBNAM Core: Perm Type: Char	Organization.name 0..1 string org-1	Observation.performer.where($this is Organization).resolve().name
Reference Range Indicator	LBCNRIND	LBNRIND Core: Exp Type: Char	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system ='NRIND')	Must map to CDISC controlled terminology
Standard Toxicity Grade		LBTOXGR Core: Perm Type: Char	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).coding.code	Must map to sponsor-determind terminology
Toxicity Grade Code List Version	LBCTOXV	LBTOX Core: Perm Type: Char	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).coding.version	Typically FHIR systems will only populate Coding.version where the terminology is ill-behaved and code meanings change over time. The code system version doesn't convey what value set the user was choosing from (which could be a subset of the codes from the code system or could draw from multiple code systems).
Toxicity Grade Code List	LBCTOX	LBTOX Core: Perm Type: Char	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).system	Note that the system doesn't define the value set nor does it specify value set version or code system version(s)
Lab Ref Range Lower Limit in Orig Unit	LBORNRLO Core: R/C Type: Char	LBORNRLO Core: Exp Type: Char	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low	As reported from the lab.
Lab Ref Range Upper Limit in Orig Unit	LBORNRHI Core: R/C Type: Char	LBORNRHI Core: Exp Type: Char	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high	As reported from the lab.
Reference Range (for string value)	LBCSTNRC	LBSTNRC Core: Perm Type: Char	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.text	Sponsor would normalize this.
Lab Result or Finding in Original Units	LBORRES Core: HR Type: Char	LBORRES Core: Exp Type: Char	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value Observation.valueCodeableConcept.text	Might also include valueQuantity.comparator CDISC (and sponsors) may have different definitions about what constitutes an "original result". Sponsors will need to make a determination of whether the value found in the Observation.value meets those criteria and is appropriate to be mapped. (In some cases, what's in Observation.value could have been transformed from what was captured at the point of measurement.)
Lab Original Units	LBORRESU Core: O Type: Char	LBORRESU Core: Exp Type: Char	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.unit	Needs to be translated to match the controlled terminology, if not already compliant
Lab Clinical Significance	LBCLSIG Core: HR Type: Char	SUPPLB.QVAL	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation	As determined by the lab, not the sponsor
Method	LBCMETH	LBMETHOD Core: Perm Type: Char	Observation.method 0..1 CodeableConcept Binding: ObservationMethod example	Observation.method	Method can cover collection and many other features. In some cases, collection method may be inferred from the Observation.code. Would need to map to CDISC controlled terminology
Anatomical Region		LBLOC*	Specimen.collection.bodySite 0..1 CodeableConcept Binding: BodySite example	Observation.specimen.resolve().collection.bodySite	In some cases, the anatomical location can be inferred from the Observation.code. Would need to map to CDISC controlled terminology.
Run ID	LBRUNID	LBRUNID*	Would need to introduce an extension	May not be applicable for safety labs.
Unique Subject Identifier		USUBJID Core: Req Type: Char	Patient.identifier 0..* Identifier	Observation.subject.resolve().identifier	To find an identifier that was consistent for the subject across studies would typically mean looking to the Patient identifier. However, this may not be appropriate to be exposed directly, so some degree of mapping, obfuscation or anonymization may be required. In theory, a sponsor specific study-independent identifier could be maintained on Patient alongside other patient identifiers, but this would be unusual in most clinical systems.
Result Categorization	LBRESCAT	LBRESCAT*	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation	This wouldn't come from the lab. It could be added after the fact. If so, this would be the mapping
Anatomical Region	LBANTREG	LBANTREG*	Specimen.collection.bodySite 0..1 CodeableConcept Binding: BodySite example	Observation.specimen.resolve().collection.bodySite	Not differentiated from LBLOC. Not for basic safety labs
Unscheduled Flag	LBUSCHFL	LBUSCHFL*	This can sort of be inferred from the absence of a link to a PlanDefinition or ActivityDefinition, however there are lots of other reasons these links could be missing, so that's not totally reliable. Could look at using an extension or a tag Not generally used for human clinical trials
Planned Time Point Number		LBTPTNUM Core: Perm Type: Num	Pull this information from the Clinical Plan (PlanDefinition)	Link to the clinical plan would be through the Observation.basedOn link to CarePlan or the instantiatesCanonical link to PlanDefinition or ActivityDefinition
Analytical Method		LBANMETH*	This does not apply to safety labs.	The corresponding values need to be evaluated and aligned accordingly to the CDISC context of --METHOD. Potentially could appear in Observation.method. An extension is required to distinguish.
Baseline Flag		LBBLFL Core: Exp Type: Char	Variable may be deprecated. This information would come from the Sponsor.	Could appear in Observation.reasonCode. In practice the notion of 'baseline' is more of a relationship. Any arbitrary Observation might be selected as the 'baseline' for a particular step in the study. As such, the real linkage is the tie to the CarePlan activity that's tied to the ActivityDefinition with a reason of 'baseline'.
Derived Flag		LBDRVFL Core: Perm Type: Char	This information would come from the Sponsor.	FHIR doesn't use a flag. If an Observation is derived, it should point to the Observations it's derived from with the derivedFrom association. (If that relationship is present, then the Derived Flag is true)

CDISC

FHIR map (or gap)

Comment

Label

CDASH

SDTM

Element

FHIRPath

Study Identifier

DM.STUDYID
Core: HR
Type: Char

DM.STUDYID
Core: Req
Type: Char

ResearchStudy.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).study.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.

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

DM.SITEID
Core: HR
Type: Char

DM.SITEID
Core: Req
Type: Char

ResearchStudy.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).study.resolve().identifier

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

Investigator Identifier

DM.INVID
Core: Perm
Type: Char

Practitioner.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier

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

Will need to decide which id to expose. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy.

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

Subject Identifier for the Study

DM.SUBJID
Core: HR
Type: Char

DM.SUBJID
Core: Req
Type: Char

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(individual=Observation.subject).identifier

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

No standard way to decide which subject identifier to use

Visit Number

VISITNUM

VISITNUM
Core: Exp
Type: Num

Encounter.identifier
0..* Identifier

Observation.encounter.resolve().identifier

This won't necessarily correlate with the protocol-defined visit number. Correspondance to a protocol-defined visit will typically require rules-based analysis based on time, encounter type and other factors.

Visit Name

VISIT
Core: R/C
Type: Char

VISIT
Core: Perm
Type: Char

ActivityDefinition.name
0..1 string inv-0

Observation.encounter.resolve().extension(workflow-instantiates).valueCanonical.resolve().title

In most cases, real world data won't have a direct association to a study protocol activity and the link would need to be inferred. However, if it exists, it would map as follows:

We could go through Encounter.basedOn-> ServiceRequest.instantiatesCanonical, you arrive at ActivityDefinition. Encounter should have a standard instantiatesCanonical extension that would allow pointing to the ActivityDefinition. This would be the ActivityDefinition.name. Submit a change request to add the extension

Lab Specimen ID

LBREFID
Core: R/C
Type: Char

LBREFID
Core: Perm
Type: Char

Specimen.accessionIdentifier
0..1 Identifier

Observation.specimen.resolve().accessionIdentifier

As reported from the Site

Date/Time of Specimen Collection

LBDTC
Core: Exp
Type: Char
values: ISO 8601

Specimen.collection.collectedDateTime
0..1 dateTime

Observation.specimen.resolve().collection.collectedDateTime

NOTE: no mapping included for CDASH LBDAT and LBTIM To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.start

End Date/Time of Specimen Collection

LBENDTC
Core: Perm
Type: Char
values: ISO 8601

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.end

NOTE: No mapping included for CDASH LBENDAT and LBENTIM)

To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)

Specimen Collection Duration (for Clinical Research with extended time of collection)

LBCDUR

LBDUR*

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod

Will need to convert value and unit to ISO syntax. E.g. 90 min would convert to PT1H30M

Specimen Planned Time Point Name (Planned Collection Time Point - time within Encounter)

LBCTPT

LBTPT
Core: Perm
Type: Char

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('reference').valueReference.reference.resolve().title

Typically named timepoints won't exist in real-world data and the timing point name will need to be assigned by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there.

Specimen Planned Elapsed Time from Time Point Reference

LBCELTM

LBELTM
Core: Perm
Type: Char
values: ISO 8601

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('offset').valueDuration

Typically named timepoints won't exist in real-world data and the timing point offset will need to be calculated by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there. If present, would need to translate to ISO-8601

Specimen Condition

LBCSPCCN

LBSPCCND
Core: Perm
Type: Char

Specimen.condition
0..* CodeableConcept
Binding: SpecimenCondition extensible

Observation.specimen.resolve().condition.coding.code

Recommend submitting change proposals to extend the FHIR vocabulary to include CDISC values. Sponsor will need to decide how to map when FHIR terminology contains codes not present in CDISC.

NOTE: requires an extension to the FHIR vocabulary to include CDISC values (e.g., Refrigerated). An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.

Specimen Type

LBCSPEC

LBSPEC
Core: Perm
Type: Char

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().type.coding.display

NOTE: In some cases, this may be inferred from the LOINC.

FHIR terminology is not standardized. Sponsor will need to map to CDISC terminology if raw data does not use CDISC codes. An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.

Fasting Status

LBCFAST

LBFAST
Core: Perm
Type: Char

Specimen.collection.fastingStatusCodeableConcept
0..1 CodeableConcept
Binding: FastingStatus extensible

Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code

FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable.

If fastingStatusDuration is present and non-zero, that would also map to 'Y'. In some cases, this may be inferred from the LOINC term (Challenge). For example, Challenge=post CFst to signify a calorie fast.

Lab Test Condition Met

LBCOND
Core: R/C
Type: Char

This is an 'ask on entry' question. May be able to determine some conditions, such as fasting, by using other specimen.collection attributes (e.g., fasting status). Others might be captured as components or extensions. Alternatively, obtain this information from the case report form entries.

There are explicit elements for Specimen.collection.fastingStatus and collection.fastingDuration. May need extensions for other pre-conditions

Specimen Collection Position

LBCPOS

LBPOS*

Specimen.collection
0..1 BackboneElement

Observation.specimen.resolve().collection.extension(observation-bodyPosition).valueCodeableConcept

As reported from the lab. Will need to map to CDISC controlled terminology

Specimen Usability for the Test

LBCSPCUF

LBSPCUFL*

Specimen.status
0..1 code
Binding: SpecimenStatus required

Observation.specimen.resolve()status.where($this='Unsatisfactory')

Need to translate to blank or N if not received as blank or N

May not be applicable for safety labs.

	FHIR map (or gap)	CDISC	Comment
Study Identifier	ResearchStudy.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().partOf.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier	DM.STUDYID Core: HR Type: Char	DM.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. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study. 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.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().identifier	DM.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 Observation is aware of its relevance to the Study.
Investigator Identifier	Practitioner.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().identifier		DM.INVID Core: Perm Type: Char	Will need to decide which id to expose. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Subject Identifier for the Study	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(individual=Observation.subject).identifier	DM.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 Observation. No standard way to decide which subject identifier to use
Visit Number	Encounter.identifier 0..* Identifier	Observation.encounter.resolve().identifier	VISITNUM	VISITNUM Core: Exp Type: Num	This won't necessarily correlate with the protocol-defined visit number. Correspondance to a protocol-defined visit will typically require rules-based analysis based on time, encounter type and other factors.
Visit Name	ActivityDefinition.name 0..1 string inv-0	Observation.encounter.resolve().extension(workflow-instantiates).valueCanonical.resolve().title	VISIT Core: R/C Type: Char	VISIT Core: Perm Type: Char	In most cases, real world data won't have a direct association to a study protocol activity and the link would need to be inferred. However, if it exists, it would map as follows: We could go through Encounter.basedOn-> ServiceRequest.instantiatesCanonical, you arrive at ActivityDefinition. Encounter should have a standard instantiatesCanonical extension that would allow pointing to the ActivityDefinition. This would be the ActivityDefinition.name. Submit a change request to add the extension
Lab Specimen ID	Specimen.accessionIdentifier 0..1 Identifier	Observation.specimen.resolve().accessionIdentifier	LBREFID Core: R/C Type: Char	LBREFID Core: Perm Type: Char	As reported from the Site
Date/Time of Specimen Collection	Specimen.collection.collectedDateTime 0..1 dateTime	Observation.specimen.resolve().collection.collectedDateTime		LBDTC Core: Exp Type: Char values: ISO 8601	NOTE: no mapping included for CDASH LBDAT and LBTIM To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)
Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.start
End Date/Time of Specimen Collection	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end		LBENDTC Core: Perm Type: Char values: ISO 8601	NOTE: No mapping included for CDASH LBENDAT and LBENTIM) To map directly, the data must be formatted in ISO 8601 date/time format (e.g., 2015-02-07T13:28:17-05:00)
Specimen Collection Duration (for Clinical Research with extended time of collection)	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod	LBCDUR	LBDUR*	Will need to convert value and unit to ISO syntax. E.g. 90 min would convert to PT1H30M
Specimen Planned Time Point Name (Planned Collection Time Point - time within Encounter)	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('reference').valueReference.reference.resolve().title	LBCTPT	LBTPT Core: Perm Type: Char	Typically named timepoints won't exist in real-world data and the timing point name will need to be assigned by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there.
Specimen Planned Elapsed Time from Time Point Reference	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).extension('offset').valueDuration	LBCELTM	LBELTM Core: Perm Type: Char values: ISO 8601	Typically named timepoints won't exist in real-world data and the timing point offset will need to be calculated by the sponsor. However, this shows where the data would be expressed in FHIR if it was present there. If present, would need to translate to ISO-8601
Specimen Condition	Specimen.condition 0..* CodeableConcept Binding: SpecimenCondition extensible	Observation.specimen.resolve().condition.coding.code	LBCSPCCN	LBSPCCND Core: Perm Type: Char	Recommend submitting change proposals to extend the FHIR vocabulary to include CDISC values. Sponsor will need to decide how to map when FHIR terminology contains codes not present in CDISC. NOTE: requires an extension to the FHIR vocabulary to include CDISC values (e.g., Refrigerated). An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.
Specimen Type	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().type.coding.display	LBCSPEC	LBSPEC Core: Perm Type: Char	NOTE: In some cases, this may be inferred from the LOINC. FHIR terminology is not standardized. Sponsor will need to map to CDISC terminology if raw data does not use CDISC codes. An "as collected" version of the SDTM variable is recommended to allow the sponsor to make adjustments to ensure terminology compliance while mapping to SDTM.
Fasting Status	Specimen.collection.fastingStatusCodeableConcept 0..1 CodeableConcept Binding: FastingStatus extensible	Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code	LBCFAST	LBFAST Core: Perm Type: Char	FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable. If fastingStatusDuration is present and non-zero, that would also map to 'Y'. In some cases, this may be inferred from the LOINC term (Challenge). For example, Challenge=post CFst to signify a calorie fast.
Lab Test Condition Met	This is an 'ask on entry' question. May be able to determine some conditions, such as fasting, by using other specimen.collection attributes (e.g., fasting status). Others might be captured as components or extensions. Alternatively, obtain this information from the case report form entries.	LBCOND Core: R/C Type: Char		There are explicit elements for Specimen.collection.fastingStatus and collection.fastingDuration. May need extensions for other pre-conditions
Specimen Collection Position	Specimen.collection 0..1 BackboneElement	Observation.specimen.resolve().collection.extension(observation-bodyPosition).valueCodeableConcept	LBCPOS	LBPOS*	As reported from the lab. Will need to map to CDISC controlled terminology
Specimen Usability for the Test	Specimen.status 0..1 code Binding: SpecimenStatus required	Observation.specimen.resolve()status.where($this='Unsatisfactory')	LBCSPCUF	LBSPCUFL*	Need to translate to blank or N if not received as blank or N May not be applicable for safety labs.
Category	DiagnosticReport.category 0..* CodeableConcept Binding: DiagnosticServiceSection example	DiagnosticReport.category.coding.where(system='LBSCAT').code	LBCCAT	LBCAT Core: Exp Type: Char	NOTE: In some cases, this may be inferred from the LOINC. It might also be found by looking for the 'panel' Obsesrvation this Observation is a part of. In most cases, translation will be required to sponsor-defined codes. It may work best for the sponsor to categorize based on TESTCD values and ignore lab-reported and EHR-determined categories entirely.
DiagnosticReport.code 1..1 CodeableConcept Binding: DiagnosticReportCodes preferred	DiagnosticReport.code
Test Status	ServiceRequest.doNotPerform 0..1 boolean	Observation.basedOn.resolve().doNotPerform	LBCSTAT	LBSTAT Core: Perm Type: Char	Sponsor may choose to map a situation in which the entire panel is cancelled as one summary record compliant with SDTM IG examples. Some sponsor may decline to accept cancelled records under specific circumstances (e.g., unscheduled) Sponsor may also choose to populate LBREASND as CANCELLED Needs to be translated from FHIR vocabulary to SDTM controlled terminology: FHIR -> CDISC: Not performed = NOT DONE Cancelled = NOT DONE Completed = <blank>
ServiceRequest.status 1..1 code Binding: ServiceRequestStatus required	Observation.basedOn.resolve().status
Reason Test Not Done	Observation.dataAbsentReason 0..1 CodeableConcept obs-6 Binding: ObservationValueAbsentReason extensible	Observation.dataAbsentReason.text		LBREASND Core: Perm Type: Char	see notes on LBSTAT
Lab Test or Examination Short Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(selected=true).code		LBTESTCD Core: Req Type: Char	Translate to compliant terminology (if needed)
Lab Test or Examination Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(selected=true).display		LBTEST Core: Req Type: Char	Translate to compliant terminology (if needed)
Test LOINC Code	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system='http://loinc.org').code	LBLOINC	LBLOINC Core: Perm Type: Char
Vendor Name	Organization.name 0..1 string org-1	Observation.performer.where($this is Organization).resolve().name	LBNAM Core: R/C Type: Char	LBNAM Core: Perm Type: Char
Reference Range Indicator	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system ='NRIND')	LBCNRIND	LBNRIND Core: Exp Type: Char	Must map to CDISC controlled terminology
Standard Toxicity Grade	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).coding.code		LBTOXGR Core: Perm Type: Char	Must map to sponsor-determind terminology
Toxicity Grade Code List Version	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).coding.version	LBCTOXV	LBTOX Core: Perm Type: Char	Typically FHIR systems will only populate Coding.version where the terminology is ill-behaved and code meanings change over time. The code system version doesn't convey what value set the user was choosing from (which could be a subset of the codes from the code system or could draw from multiple code systems).
Toxicity Grade Code List	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.where(system=[Toxicity Grade]).system	LBCTOX	LBTOX Core: Perm Type: Char	Note that the system doesn't define the value set nor does it specify value set version or code system version(s)
Lab Ref Range Lower Limit in Orig Unit	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low	LBORNRLO Core: R/C Type: Char	LBORNRLO Core: Exp Type: Char	As reported from the lab.
Lab Ref Range Upper Limit in Orig Unit	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high	LBORNRHI Core: R/C Type: Char	LBORNRHI Core: Exp Type: Char	As reported from the lab.
Reference Range (for string value)	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.text	LBCSTNRC	LBSTNRC Core: Perm Type: Char	Sponsor would normalize this.
Lab Result or Finding in Original Units	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value Observation.valueCodeableConcept.text	LBORRES Core: HR Type: Char	LBORRES Core: Exp Type: Char	Might also include valueQuantity.comparator CDISC (and sponsors) may have different definitions about what constitutes an "original result". Sponsors will need to make a determination of whether the value found in the Observation.value meets those criteria and is appropriate to be mapped. (In some cases, what's in Observation.value could have been transformed from what was captured at the point of measurement.)
Lab Original Units	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.unit	LBORRESU Core: O Type: Char	LBORRESU Core: Exp Type: Char	Needs to be translated to match the controlled terminology, if not already compliant
Lab Clinical Significance	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation	LBCLSIG Core: HR Type: Char	SUPPLB.QVAL	As determined by the lab, not the sponsor
Method	Observation.method 0..1 CodeableConcept Binding: ObservationMethod example	Observation.method	LBCMETH	LBMETHOD Core: Perm Type: Char	Method can cover collection and many other features. In some cases, collection method may be inferred from the Observation.code. Would need to map to CDISC controlled terminology
Anatomical Region	Specimen.collection.bodySite 0..1 CodeableConcept Binding: BodySite example	Observation.specimen.resolve().collection.bodySite		LBLOC*	In some cases, the anatomical location can be inferred from the Observation.code. Would need to map to CDISC controlled terminology.
Run ID	Would need to introduce an extension	LBRUNID	LBRUNID*	May not be applicable for safety labs.
Unique Subject Identifier	Patient.identifier 0..* Identifier	Observation.subject.resolve().identifier		USUBJID Core: Req Type: Char	To find an identifier that was consistent for the subject across studies would typically mean looking to the Patient identifier. However, this may not be appropriate to be exposed directly, so some degree of mapping, obfuscation or anonymization may be required. In theory, a sponsor specific study-independent identifier could be maintained on Patient alongside other patient identifiers, but this would be unusual in most clinical systems.
Result Categorization	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation	LBRESCAT	LBRESCAT*	This wouldn't come from the lab. It could be added after the fact. If so, this would be the mapping
Anatomical Region	Specimen.collection.bodySite 0..1 CodeableConcept Binding: BodySite example	Observation.specimen.resolve().collection.bodySite	LBANTREG	LBANTREG*	Not differentiated from LBLOC. Not for basic safety labs
Unscheduled Flag	This can sort of be inferred from the absence of a link to a PlanDefinition or ActivityDefinition, however there are lots of other reasons these links could be missing, so that's not totally reliable. Could look at using an extension or a tag Not generally used for human clinical trials	LBUSCHFL	LBUSCHFL*
Planned Time Point Number	Pull this information from the Clinical Plan (PlanDefinition)		LBTPTNUM Core: Perm Type: Num	Link to the clinical plan would be through the Observation.basedOn link to CarePlan or the instantiatesCanonical link to PlanDefinition or ActivityDefinition
Analytical Method	This does not apply to safety labs.		LBANMETH*	The corresponding values need to be evaluated and aligned accordingly to the CDISC context of --METHOD. Potentially could appear in Observation.method. An extension is required to distinguish.
Baseline Flag	Variable may be deprecated. This information would come from the Sponsor.		LBBLFL Core: Exp Type: Char	Could appear in Observation.reasonCode. In practice the notion of 'baseline' is more of a relationship. Any arbitrary Observation might be selected as the 'baseline' for a particular step in the study. As such, the real linkage is the tie to the CarePlan activity that's tied to the ActivityDefinition with a reason of 'baseline'.
Derived Flag	This information would come from the Sponsor.		LBDRVFL Core: Perm Type: Char	FHIR doesn't use a flag. If an Observation is derived, it should point to the Observations it's derived from with the derivedFrom association. (If that relationship is present, then the Derived Flag is true)

LAB Mappings

Guidance on interpreting the tables can be found here.

CDISC Lookup view
FHIR mapping view

CDISC	FHIR map (or gap)	Comment
Study ID or Number	/GTP/Study/@ID	ResearchStudy.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.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. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Study Name	/GTP/Study/@Name	ResearchStudy.title 0..1 string	ResearchSubject.where(subject=Observation.subject).study.resolve()partOf.resolve().title Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().title	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 Observation is aware of its relevance to the Study.
Transmission Type	/GTP/Study/@TransmissionType	Determine from type of call to service (requesting all data vs incremental data - e.g. filtering by _lastUpdated). NOTE: If data are not persisted between FHIR and LAB, cannot do incremental data processing (due to lack of delta detection).	If the data is being 'pushed' in a message, this could also be conveyed in the MessageHeader.event
Study Transaction Type	/GTP/Study/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	This would be conveyed using a transaction Bundle - specifically the Bundle.entry.request.method
Site ID or Number	/GTP/Study/Site/@ID	ResearchStudy.site 0..* Reference	ResearchSubject.where(subject=Observation.subject).study.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 Observation is aware of its relevance to the Study.
Site Transaction Type	/GTP/Study/Site/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Investigator ID or Number	/GTP/Study/Site/Investigator/@ID	Practitioner.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().identifier	Will need to decide which id to expose or may need to map to one recognized by the sponsor. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Investigator Name	/GTP/Study/Site/Investigator/@Name	Practitioner.name 0..* HumanName	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().name.text Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().name.text	Will need to decide which name to expose if there are multiples. Can also extract the prefix, given and family names if text isn't specified. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Investigator Transaction Type	/GTP/Study/Site/Investigator/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Screen ID or Number	/GTP/Study/Site/Investigator/Subject/ScreenID	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Subject ID or Number	/GTP/Study/Site/Investigator/Subject/SubjectID	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Spare subject level ID or Number	/GTP/Study/Site/Investigator/Subject/SpareSubjectID	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Subject Sex	/GTP/Study/Site/Investigator/Subject/Sex/@Value	Patient.gender 0..1 code Binding: AdministrativeGender required	Observation.subject.resolve().gender	Consider whether patient personal information is required for sponsor to perform patient reconciliation. If not, do not send this data element. The US-core birth-sex extension (if it is present) may be more consistently populated than Patient.gender. If patient gender is sent, the values must be mapped from the FHIR vocabulary to the LAB standard: male -> M female -> F other -> U unknown -> U
Subject Sex Code List ID	/GTP/Study/Site/Investigator/Subject/Sex/@CodeListID	For FHIR, the administrative gender code list is fixed, so no need to send it in the instance. If there's a need to convey alternate gender codes, then those would appear either as Observation values or as extension values on Patient (the former for clinical information, the latter for administrative purposes). In either event, the code would be in CodeableConcept.coding which allows identifying both the code system and (if relevant), the version
Subject Race	/GTP/Study/Site/Investigator/Subject/Race/@Value	There's an US-core extension (us-core-race) for capturing this in the U.S. and the possibility that other countries will define their own extensions. Note that this is for administrative, not clinical purposes. Genetic heritage would typically be captured as an Observation	Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element. If patient race is sent, use the us-core-race extension in FHIR.
Subject Race Code List ID	/GTP/Study/Site/Investigator/Subject/Race/@CodeListID	Race, whether captured as an extension or observation value is generally a CodeableConcept allowing capturing both code system and (if relevant) version. Race is highly variable from country to country (both whether it's allowed and how it's coded), so there's no standard element for this in the core spec.
Subject Initials	/GTP/Study/Site/Investigator/Subject/Confidential/@Initials	Patient.name 0..* HumanName	ResearchSubject.where(subject=Observation.subject).individual.resolve().name.text	Note that name.text will typically contain the full name, but can contain initials only. If the full name is present, initials can be extracted by looking at the given and family name components and converting to initials Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element. If required, be sure to send only the initials, derived from the name.
Subject Date Of Birth	/GTP/Study/Site/Investigator/Subject/Confidential/@Birthdate	Patient.birthDate 0..1 date	ResearchSubject.where(subject=Observation.subject).individual.resolve().birthDate	Note that precision can vary (YYYY, YYYY-MM or YYYY-MM-DD) Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element.
Visit ID or Number	/GTP/Study/Site/Investigator/Subject/Visit/@ID	Encounter.identifier 0..* Identifier	Observation.encounter.resolve().identifier	No standard way to decide which identifier to use if multiples are present
Visit Name	/GTP/Study/Site/Investigator/Subject/Visit/@Name	In practice, visit name would be the ActivityDefinition.title for the activity in the protocol associated with the encounter. There is no standard extension for this link (though one will be defined). Most clinical systems won't actually capture this, so the determination will need to be made at time of data extraction based on the protocol	See LB mapping comment
Visit Type	/GTP/Study/Site/Investigator/Subject/Visit/@Type	This is essentially whether the visit is tied to a particular activity within the PlanDefinition (study protocol) or not. Given that in non-study-specific systems, there won't typically be a linkage even when the encounter is driven by the study, this will generally need to be populated algorithmically on extension	This could theoretically be distinguished by whether there was a link to a CarePlan activity or ActivityDefinition. Alternatively, you could use an extension or tag. (What's 'planned' for one study might be unplanned for another) This would be Encounter.reasonCode
Visit Type Modifier	/GTP/Study/Site/Investigator/Subject/Visit/@TypeModifier	Encounter.reasonCode 0..* CodeableConcept Binding: EncounterReason preferred	Observation.encounter.resolve().reasonCode	This would be Encounter.reasonCode
Subject Transaction Type	/GTP/Study/Site/Investigator/Subject/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Accession ID or Number	/GTP/Study/Site/Investigator/Subject/Visit/Accession/@ID	Specimen.accessionIdentifier 0..1 Identifier	Observation.resolve().accessionIdentifier
Last Active Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/@LastActiveDateTime	FHIR allows capture meta.lastUpdated which reflects when the data last changed on the server in question, but would need to look at Provenance to see when data last changed on a particular system. This typically won't be available.
Visit Transaction Type	/GTP/Study/Site/Investigator/Subject/Visit/Accession/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Central Laboratory ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@ID	Organization.identifier 0..* Identifier org-1	Observation.performer.resolve().identifier	Will need to look at identifier.type or identifier.system to know which identifier to use. In some cases, performer might be PractitionerRole, in which case, will need to map through PractitionerRole.organization. If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.
Central Laboratory Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@Name	Organization.name 0..1 string org-1	Observation.performer.resolve().name	If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.
Specimen ID or Number	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/@ID	Specimen.identifier 0..* Identifier	Observation.specimen.resolve().identifier	If there are multiple identifiers, need to look at identifier.system or identifier.type to determine
Actual Collection Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@ActualCollectionDateTime	Specimen.collection.collectedDateTime 0..1 dateTime	Observation.specimen.resolve().collection.collectedDateTime	Most of the time there'll only be a single dateTime. If collected over a period of time (e.g. urine), use the end.
Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end
Planned Collection Time Elapsed	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsed	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).valueDuration	Will need to convert value + units into an ISO duration
Planned Collection Time Elapsed Description	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsedDescription	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).valueReference.reference	The event would be in extension('target').valueReference.display and the time would be in extension('offset').valueDuration value and unit.
Collection End Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@CollectionEndDateTime	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end
Received Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@ReceivedDateTime	Specimen.receivedTime 0..1 dateTime	Observation.specimen.resolve().receivedTime
Specimen Condition	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@SpecimenCondition	Specimen.condition 0..* CodeableConcept Binding: SpecimenCondition extensible	Observation.specimen.resolve().condition.coding.code	Will need to choose which coding to extract the code for
Investigator - Specimen Comment Source	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source	Practitioner.identifier 0..* Identifier	Observation.specimen.resolve().note.author.resolve().where($thisisPractitioner).identifier	Note that practitioners can have multiple identifiers - use type or system to decide which identifier to expose
Investigator - Specimen Comment Text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text	Specimen.note 0..* Annotation	Observation.specimen.resolve().where($author.resolve()isPractitioner).note.text
Lab - Specimen Comment Source	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source	Observation.identifier 0..* Identifier	Observation.specimen.resolve().note.author.resolve().where($thisisOrganization).identifier	Note that organizations can have multiple identifiers - use type or system to decide which identifier to expose
Lab - Specimen Comment Text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text	Specimen.note 0..* Annotation	Observation.specimen.resolve().where($author.resolve() isOrganization).note.text
Specimen Material ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@ID	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.code	If multiple codes are present, filter based on system
Specimen Material Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@Name	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.display	If multiple codes are present, filter based on system. Translation may be required
Specimen Material Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@CodeListID	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.system	If multiple codings are present, will need to decide which to use
Subject Age at Collection	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeAtCollection	If captured as an Observation, this would be in the ValueQuantity.code derived from the patient.birthDate(Observation.subject (ref:Patient.birthDate). If the full birthdate cannot be shared, due to country restrictions, use the birth year to derive age information. Due to lost accuracy in having only the year of birth, 'years' would be the default unit. As an alternative use the cqf-relativeTime extension on Patient.birthDate and convey as a relative time to study enrollment
Subject Age Units	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeUnits	If captured as an Observation, this would be in the ValueQuantity.code derived from the patient.birthDate(Observation.subject (ref:Patient.birthDate). If the full birthdate cannot be shared, due to country restrictions, use the birth year to derive age information. Due to lost accuracy in having only the year of birth, 'years' would be the default unit.
Fasting Status	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@FastingStatus	Specimen.collection.fastingStatusCodeableConcept 0..1 CodeableConcept Binding: FastingStatus extensible	Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code	FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable (blank) If fastingStatusDuration is present and non-zero, that would also map to 'Y'. There are times where this can be inferred from the Observation.code.
Battery ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@ID	DiagnosticReport.identifier 0..* Identifier	DiagnosticReport.identifier
Battery Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@Name	DiagnosticReport.code 1..1 CodeableConcept Binding: DiagnosticReportCodes preferred	DiagnosticReport.code.text
Battery Transaction Type	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Test Status	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@Status	ServiceRequest.doNotPerform 0..1 boolean	Observation.basedOn.resolve().doNotPerform	Multiple fields are required to populate this value per the standard. Use ServiceRequest.status and ServiceRequest.doNotPerform (doNotPerform will only be true if the test is not to be performed) to represent the test status. From these two fields, sponsors will need to translate to the CDISC test statuses: D - Done N - Not Performed X - Cancelled.
ServiceRequest.status 1..1 code Binding: ServiceRequestStatus required	Observation.basedon.resolve().status
Testing Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestingDateTime	Observation.effectiveDateTime 0..1 dateTime	Observation.effectiveDateTime
Test Type	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestType	The normal transmission of data, via FHIR, is for study tests. If non-study test results are required (e.g., AdverseEvent follow-up), these would be obtained via a special request from the data provider. Alternatively, if the system requires this field to be populated, derive whether the test was for the study or not, use the ServiceRequest resource.	Differentiation would be whether the Observation was basedOn a particular activity in the CarePlan (scheduled) or tied to a particular ActivityDefinition (Study test)
Performing Laboratory ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@ID	Organization.identifier 0..* Identifier org-1	Observation.performer.resolve().identifier	Use "Organization/type" to pick the type of Organization that represents "Performing Lab"
Performing Laboratory Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@Name	Organization.name 0..1 string org-1	Observation.performer.resolve().name
Lab Test ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@ID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system = 'Lab Test')	Since this is a codeable concept, there may be multiple codes for a test. The sponsor will have to determine which is the "lab's" code vs. "receiver's" code vs. others.
Lab Test Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.display
Additional Test Description	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@AdditionalDescription	Observation.note 0..* Annotation	Observation.note.text	Not all notes will necessarily be appropriate to map here. Would need to decide whether to also bring across authors and dates and would need to combined multiple repetitions into a single string.
Receiver Test ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@ID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where (system = [Recipient Test])	Observation/code/coding/system/@value ("system" element used to designate the type of code that is being represented (in this case the "ReceiverTest") by the "code" element)
Receiver Test Name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.display where (coding system = 'Recipient Test')
LOINC Code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@Value	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where (coding system = 'http://loinc.org')
LOINC Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@CodeListID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system = 'http://loinc.org')	This will always be 'LOINC'
Test Level Comments	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TestLevelComment	Observation.extension 0..* Extension	Observation.note.text	Will need to determine whether to also incude date and author.
Reported Result Status	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedResultStatus	Observation.status 1..1 code Binding: ObservationStatus required	Observation.status	This has two possible values: P for Preliminary and F for Final.
Alert Flag	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@AlertFlag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where(system='Alert Flag')	The alert flag generated by the reference ranges applied and tied to the reported result. There are 9 alert flag values: LP - Low Panic LT - Low Telephone LN - Low Normal N - Normal HN - High Normal HT - High Telephone HP - High Panic AB - Abnormal and blank when not used. It may be necessary to translate from other interpretation codings.
Delta Flag	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@DeltaFlag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Delta Flag')	The delta flag generated by the reference ranges applied and tied to the reported result. There are three delta flags: D+ for an increase in value D- for a decrease in value and blank for no flag. It may be necessary to translate from other interpretation codings.
Exclusion Flag	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ExclusionFlag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Exclusion Flag')	The exclusion flag generated by the reference ranges applied and tied to the reported result. There are four exclusion flag values: LX - Low Exclusion HX - High Exclusion EX - Excluded (for exclusions not falling under high or low) and blank for no flag. It may be necessary to translate from other
Blinding Flag	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@BlindingFlag	Observation.meta 0..1 Meta	Observation.meta.security.code	A new code would likely be needed to specifically designate 'blinded'.
Reported Date and Time	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedDateTime	Observation.issued 0..1 instant	Observation.issued
Test Transaction Type	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TransactionType	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Toxicity Grade	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@Value	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Toxicity Grade').code	If there are multiple possible systems, the sponsor will have to determine which interpretation corresponds to toxicity grade
Toxicity Grade Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@CodeListID	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Toxicity Grade')	May need to translate the URI to a CDISC Code List id
Reported Result Type (C=coded; N=numeric; T=text; R=range; G = GT; L = LT)	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/@ResultType	Determine from the field in which the result resides. valueCodeableConcept vs. valueQuantity vs. valueString Greater than and less than can be determined by valueQuantity.qualifier
Text Result	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@Value	Observation.valueCodeableConcept 0..1 CodeableConcept obs-7	Observation.valueCodeableConcept.text
Text Result Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@CodeListID	Observation.valueCodeableConcept 0..1 CodeableConcept obs-7	Observation.valueCodeableConcept.coding.system	May need to convert from URI to CDISC-recognized 'ID'
Conventional Numeric Result	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.
Reported Numeric Result	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value
SI Numeric Result	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.
Conventional Numeric Result Precision	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.
Reported Numeric Result Precision	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value
SI Numeric Result Precision	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.
Conventional Reference Range Low	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.
Reported Reference Range Low	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	Will need to combine value and unit into a string.
SI Reference Range Low	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.
Conventional Reference Range High	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.
Reported Reference Range High	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	Will need to combine value and unit into a string.
SI Reference Range High	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.
Conventional Units	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code Observation.valueQuantity.extension('PQ-translation').code	If the reported units are not the same as conventional, can convey with the translation extension. Translation to CDISC terminology may be required.
Reported Units	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code	This may require translation to CDISC terminology
SI Units	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code Observation.valueQuantity.extensoin('PQ-translation').code	If the reported units are not SI units, can convey with the translation extension. Translation to CDISC terminology may be required.
Conventional Units Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system
Reported Units Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system
SI Units Code List ID	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system
Record Extension Type		Populate with a default value, depending on the type of data being transmitted. E.g., "BASE"
Result Class	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultClass/@Value	In FHIR, the value will always be 'reported', with the ability to convey translations in an extension. Nothing will differentiate whether a translation is considered 'conventional' or not, so if there are multiple translations present and the receiver can't figure it out by looking, an additional extension may be necessary to differentiate. This can sometimes also be inferred from the Observation.code.
Model Version	/GTP/@ModelVersion	Populate with a default value.	The version of FHIR in use is conveyed using Resource.meta.profile
File Creation Date and Time	/GTP/@CreationDateTime	Pull from the message wrapper. (file creation date)	Bundle.timestamp
Transaction Type	/GTP/TransactionType	No mitigation. If required, fill with a default value.	As per study.transaction
Transmission Source ID	/GTP/TransmissionSource/@ID	Pull from the message wrapper.	MessageHeader.source.endpoint if using messaging, otherwise determined out of band based on sender authentication process
Transmission Source Name	/GTP/TransmissionSource/@Name	Pull from the message wrapper.	MessageHeader.source.name if using messaging, otherwise determined out of band based on sender authentication process

CDISC

FHIR map (or gap)

Comment

Label

LAB

Element

FHIRPath

Study ID or Number

/GTP/Study/@ID

ResearchStudy.identifier
0..* Identifier

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

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

Study Name

/GTP/Study/@Name

ResearchStudy.title
0..1 string

ResearchSubject.where(subject=Observation.subject).study.resolve()partOf.resolve().title

Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().title

Transmission Type

/GTP/Study/@TransmissionType

Determine from type of call to service (requesting all data vs incremental data - e.g. filtering by _lastUpdated). NOTE: If data are not persisted between FHIR and LAB, cannot do incremental data processing (due to lack of delta detection).

If the data is being 'pushed' in a message, this could also be conveyed in the MessageHeader.event

Study Transaction Type

/GTP/Study/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

This would be conveyed using a transaction Bundle - specifically the Bundle.entry.request.method

Site ID or Number

/GTP/Study/Site/@ID

ResearchStudy.site
0..* Reference

ResearchSubject.where(subject=Observation.subject).study.resolve().identifier

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

Site Transaction Type

/GTP/Study/Site/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Investigator ID or Number

/GTP/Study/Site/Investigator/@ID

Practitioner.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier

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

Will need to decide which id to expose or may need to map to one recognized by the sponsor. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy.

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

Investigator Name

/GTP/Study/Site/Investigator/@Name

Practitioner.name
0..* HumanName

ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().name.text

Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().name.text

Will need to decide which name to expose if there are multiples. Can also extract the prefix, given and family names if text isn't specified.

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

Investigator Transaction Type

/GTP/Study/Site/Investigator/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Screen ID or Number

/GTP/Study/Site/Investigator/Subject/ScreenID

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers.

No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.

Subject ID or Number

/GTP/Study/Site/Investigator/Subject/SubjectID

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

Spare subject level ID or Number

/GTP/Study/Site/Investigator/Subject/SpareSubjectID

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

Subject Sex

/GTP/Study/Site/Investigator/Subject/Sex/@Value

Patient.gender
0..1 code
Binding: AdministrativeGender required

Observation.subject.resolve().gender

Consider whether patient personal information is required for sponsor to perform patient reconciliation. If not, do not send this data element. The US-core birth-sex extension (if it is present) may be more consistently populated than Patient.gender.

If patient gender is sent, the values must be mapped from the FHIR vocabulary to the LAB standard: male -> M female -> F other -> U unknown -> U

Subject Sex Code List ID

/GTP/Study/Site/Investigator/Subject/Sex/@CodeListID

For FHIR, the administrative gender code list is fixed, so no need to send it in the instance. If there's a need to convey alternate gender codes, then those would appear either as Observation values or as extension values on Patient (the former for clinical information, the latter for administrative purposes). In either event, the code would be in CodeableConcept.coding which allows identifying both the code system and (if relevant), the version

Subject Race

/GTP/Study/Site/Investigator/Subject/Race/@Value

There's an US-core extension (us-core-race) for capturing this in the U.S. and the possibility that other countries will define their own extensions. Note that this is for administrative, not clinical purposes. Genetic heritage would typically be captured as an Observation

Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element.

If patient race is sent, use the us-core-race extension in FHIR.

Subject Race Code List ID

/GTP/Study/Site/Investigator/Subject/Race/@CodeListID

Race, whether captured as an extension or observation value is generally a CodeableConcept allowing capturing both code system and (if relevant) version. Race is highly variable from country to country (both whether it's allowed and how it's coded), so there's no standard element for this in the core spec.

Subject Initials

/GTP/Study/Site/Investigator/Subject/Confidential/@Initials

Patient.name
0..* HumanName

ResearchSubject.where(subject=Observation.subject).individual.resolve().name.text

Note that name.text will typically contain the full name, but *can* contain initials only. If the full name is present, initials can be extracted by looking at the given and family name components and converting to initials

Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element. If required, be sure to send only the initials, derived from the name.

Subject Date Of Birth

/GTP/Study/Site/Investigator/Subject/Confidential/@Birthdate

Patient.birthDate
0..1 date

ResearchSubject.where(subject=Observation.subject).individual.resolve().birthDate

Note that precision can vary (YYYY, YYYY-MM or YYYY-MM-DD)

Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element.

Visit ID or Number

/GTP/Study/Site/Investigator/Subject/Visit/@ID

Encounter.identifier
0..* Identifier

Observation.encounter.resolve().identifier

No standard way to decide which identifier to use if multiples are present

Visit Name

/GTP/Study/Site/Investigator/Subject/Visit/@Name

In practice, visit name would be the ActivityDefinition.title for the activity in the protocol associated with the encounter. There is no standard extension for this link (though one will be defined). Most clinical systems won't actually capture this, so the determination will need to be made at time of data extraction based on the protocol

See LB mapping comment

Visit Type

/GTP/Study/Site/Investigator/Subject/Visit/@Type

This is essentially whether the visit is tied to a particular activity within the PlanDefinition (study protocol) or not. Given that in non-study-specific systems, there won't typically be a linkage even when the encounter *is* driven by the study, this will generally need to be populated algorithmically on extension

This could theoretically be distinguished by whether there was a link to a CarePlan activity or ActivityDefinition. Alternatively, you could use an extension or tag. (What's 'planned' for one study might be unplanned for another)

This would be Encounter.reasonCode

Visit Type Modifier

/GTP/Study/Site/Investigator/Subject/Visit/@TypeModifier

Encounter.reasonCode
0..* CodeableConcept
Binding: EncounterReason preferred

Observation.encounter.resolve().reasonCode

This would be Encounter.reasonCode

Subject Transaction Type

/GTP/Study/Site/Investigator/Subject/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Accession ID or Number

/GTP/Study/Site/Investigator/Subject/Visit/Accession/@ID

Specimen.accessionIdentifier
0..1 Identifier

Observation.resolve().accessionIdentifier

Last Active Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/@LastActiveDateTime

FHIR allows capture meta.lastUpdated which reflects when the data last changed on the server in question, but would need to look at Provenance to see when data last changed on a particular system. This typically won't be available.

Visit Transaction Type

/GTP/Study/Site/Investigator/Subject/Visit/Accession/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Central Laboratory ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@ID

Organization.identifier
0..* Identifier org-1

Observation.performer.resolve().identifier

Will need to look at identifier.type or identifier.system to know which identifier to use. In some cases, performer might be PractitionerRole, in which case, will need to map through PractitionerRole.organization. If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.

Central Laboratory Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@Name

Organization.name
0..1 string org-1

Observation.performer.resolve().name

If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.

Specimen ID or Number

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/@ID

Specimen.identifier
0..* Identifier

Observation.specimen.resolve().identifier

If there are multiple identifiers, need to look at identifier.system or identifier.type to determine

Actual Collection Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@ActualCollectionDateTime

Specimen.collection.collectedDateTime
0..1 dateTime

Observation.specimen.resolve().collection.collectedDateTime

Most of the time there'll only be a single dateTime. If collected over a period of time (e.g. urine), use the end.

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.end

Planned Collection Time Elapsed

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsed

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).valueDuration

Will need to convert value + units into an ISO duration

Planned Collection Time Elapsed Description

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsedDescription

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).valueReference.reference

The event would be in extension('target').valueReference.display and the time would be in extension('offset').valueDuration value and unit.

Collection End Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@CollectionEndDateTime

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.end

Received Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@ReceivedDateTime

Specimen.receivedTime
0..1 dateTime

Observation.specimen.resolve().receivedTime

Specimen Condition

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@SpecimenCondition

Specimen.condition
0..* CodeableConcept
Binding: SpecimenCondition extensible

Observation.specimen.resolve().condition.coding.code

Will need to choose which coding to extract the code for

Investigator - Specimen Comment Source

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source

Practitioner.identifier
0..* Identifier

Observation.specimen.resolve().note.author.resolve().where($thisisPractitioner).identifier

Note that practitioners can have multiple identifiers - use type or system to decide which identifier to expose

Investigator - Specimen Comment Text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text

Specimen.note
0..* Annotation

Observation.specimen.resolve().where($author.resolve()isPractitioner).note.text

Lab - Specimen Comment Source

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source

Observation.identifier
0..* Identifier

Observation.specimen.resolve().note.author.resolve().where($thisisOrganization).identifier

Note that organizations can have multiple identifiers - use type or system to decide which identifier to expose

Lab - Specimen Comment Text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text

Specimen.note
0..* Annotation

Observation.specimen.resolve().where($author.resolve() isOrganization).note.text

Specimen Material ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@ID

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.code

If multiple codes are present, filter based on system

Specimen Material Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@Name

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.display

If multiple codes are present, filter based on system. Translation may be required

Specimen Material Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@CodeListID

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.system

If multiple codings are present, will need to decide which to use

Subject Age at Collection

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeAtCollection

If captured as an Observation, this would be in the ValueQuantity.code derived from the patient.birthDate(Observation.subject (ref:Patient.birthDate).

If the full birthdate cannot be shared, due to country restrictions, use the birth year to derive age information. Due to lost accuracy in having only the year of birth, 'years' would be the default unit. As an alternative use the cqf-relativeTime extension on Patient.birthDate and convey as a relative time to study enrollment

Subject Age Units

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeUnits

Fasting Status

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@FastingStatus

Specimen.collection.fastingStatusCodeableConcept
0..1 CodeableConcept
Binding: FastingStatus extensible

Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code

FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable (blank)

If fastingStatusDuration is present and non-zero, that would also map to 'Y'. There are times where this can be inferred from the Observation.code.

Battery ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@ID

DiagnosticReport.identifier
0..* Identifier

DiagnosticReport.identifier

Battery Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@Name

DiagnosticReport.code
1..1 CodeableConcept
Binding: DiagnosticReportCodes preferred

DiagnosticReport.code.text

Battery Transaction Type

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Test Status

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@Status

ServiceRequest.doNotPerform
0..1 boolean

Observation.basedOn.resolve().doNotPerform

Multiple fields are required to populate this value per the standard.

Use ServiceRequest.status and ServiceRequest.doNotPerform (doNotPerform will only be true if the test is not to be performed) to represent the test status. From these two fields, sponsors will need to translate to the CDISC test statuses: D - Done N - Not Performed X - Cancelled.

ServiceRequest.status
1..1 code
Binding: ServiceRequestStatus required

Observation.basedon.resolve().status

Testing Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestingDateTime

Observation.effectiveDateTime
0..1 dateTime

Observation.effectiveDateTime

Test Type

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestType

The normal transmission of data, via FHIR, is for study tests. If non-study test results are required (e.g., AdverseEvent follow-up), these would be obtained via a special request from the data provider. Alternatively, if the system requires this field to be populated, derive whether the test was for the study or not, use the ServiceRequest resource.

Differentiation would be whether the Observation was basedOn a particular activity in the CarePlan (scheduled) or tied to a particular ActivityDefinition (Study test)

Performing Laboratory ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@ID

Organization.identifier
0..* Identifier org-1

Observation.performer.resolve().identifier

Use "Organization/type" to pick the type of Organization that represents "Performing Lab"

Performing Laboratory Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@Name

Organization.name
0..1 string org-1

Observation.performer.resolve().name

Lab Test ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@ID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where(system = 'Lab Test')

Since this is a codeable concept, there may be multiple codes for a test. The sponsor will have to determine which is the "lab's" code vs. "receiver's" code vs. others.

Lab Test Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@Name

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.display

Additional Test Description

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@AdditionalDescription

Observation.note
0..* Annotation

Observation.note.text

Not all notes will necessarily be appropriate to map here. Would need to decide whether to also bring across authors and dates and would need to combined multiple repetitions into a single string.

Receiver Test ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@ID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where (system = [Recipient Test])

Observation/code/coding/system/@value ("system" element used to designate the type of code that is being represented (in this case the "ReceiverTest") by the "code" element)

Receiver Test Name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@Name

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.display where (coding system = 'Recipient Test')

LOINC Code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@Value

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where (coding system = 'http://loinc.org')

LOINC Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@CodeListID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where(system = 'http://loinc.org')

This will always be 'LOINC'

Test Level Comments

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TestLevelComment

Observation.extension
0..* Extension

Observation.note.text

Will need to determine whether to also incude date and author.

Reported Result Status

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedResultStatus

Observation.status
1..1 code
Binding: ObservationStatus required

Observation.status

This has two possible values: P for Preliminary and F for Final.

Alert Flag

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@AlertFlag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where(system='Alert Flag')

The alert flag generated by the reference ranges applied and tied to the reported result. There are 9 alert flag values:

LP - Low Panic LT - Low Telephone LN - Low Normal N - Normal HN - High Normal HT - High Telephone HP - High Panic AB - Abnormal and blank when not used. It may be necessary to translate from other interpretation codings.

Delta Flag

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@DeltaFlag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Delta Flag')

The delta flag generated by the reference ranges applied and tied to the reported result. There are three delta flags:

D+ for an increase in value D- for a decrease in value and blank for no flag. It may be necessary to translate from other interpretation codings.

Exclusion Flag

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ExclusionFlag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Exclusion Flag')

The exclusion flag generated by the reference ranges applied and tied to the reported result. There are four exclusion flag values:

LX - Low Exclusion HX - High Exclusion EX - Excluded (for exclusions not falling under high or low) and blank for no flag. It may be necessary to translate from other

Blinding Flag

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@BlindingFlag

Observation.meta
0..1 Meta

Observation.meta.security.code

A new code would likely be needed to specifically designate 'blinded'.

Reported Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedDateTime

Observation.issued
0..1 instant

Observation.issued

Test Transaction Type

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TransactionType

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Toxicity Grade

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@Value

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Toxicity Grade').code

If there are multiple possible systems, the sponsor will have to determine which interpretation corresponds to toxicity grade

Toxicity Grade Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@CodeListID

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Toxicity Grade')

May need to translate the URI to a CDISC Code List id

Reported Result Type (C=coded; N=numeric; T=text; R=range; G = GT; L = LT)

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/@ResultType

Determine from the field in which the result resides. valueCodeableConcept vs. valueQuantity vs. valueString Greater than and less than can be determined by valueQuantity.qualifier

Text Result

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@Value

Observation.valueCodeableConcept
0..1 CodeableConcept obs-7

Observation.valueCodeableConcept.text

Text Result Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@CodeListID

Observation.valueCodeableConcept
0..1 CodeableConcept obs-7

Observation.valueCodeableConcept.coding.system

May need to convert from URI to CDISC-recognized 'ID'

Conventional Numeric Result

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.

Reported Numeric Result

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

SI Numeric Result

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.

Conventional Numeric Result Precision

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

Determine the precision from the value.

Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.

Reported Numeric Result Precision

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

Determine the precision from the value.

Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value

SI Numeric Result Precision

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

Determine the precision from the value.

Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.

Conventional Reference Range Low

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.

Reported Reference Range Low

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

Will need to combine value and unit into a string.

SI Reference Range Low

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.

Conventional Reference Range High

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.

Reported Reference Range High

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

Will need to combine value and unit into a string.

SI Reference Range High

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.

Conventional Units

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

Observation.valueQuantity.extension('PQ-translation').code

If the reported units are not the same as conventional, can convey with the translation extension. Translation to CDISC terminology may be required.

Reported Units

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

This may require translation to CDISC terminology

SI Units

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

Observation.valueQuantity.extensoin('PQ-translation').code

If the reported units are not SI units, can convey with the translation extension. Translation to CDISC terminology may be required.

Conventional Units Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

Reported Units Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

SI Units Code List ID

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

Record Extension Type

Populate with a default value, depending on the type of data being transmitted.

E.g., "BASE"

Result Class

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultClass/@Value

In FHIR, the value will always be 'reported', with the ability to convey translations in an extension. Nothing will differentiate whether a translation is considered 'conventional' or not, so if there are multiple translations present and the receiver can't figure it out by looking, an additional extension may be necessary to differentiate. This can sometimes also be inferred from the Observation.code.

Model Version

/GTP/@ModelVersion

Populate with a default value.

The version of FHIR in use is conveyed using Resource.meta.profile

File Creation Date and Time

/GTP/@CreationDateTime

Pull from the message wrapper. (file creation date)

Bundle.timestamp

Transaction Type

/GTP/TransactionType

No mitigation. If required, fill with a default value.

As per study.transaction

Transmission Source ID

/GTP/TransmissionSource/@ID

Pull from the message wrapper.

MessageHeader.source.endpoint if using messaging, otherwise determined out of band based on sender authentication process

Transmission Source Name

/GTP/TransmissionSource/@Name

Pull from the message wrapper.

MessageHeader.source.name if using messaging, otherwise determined out of band based on sender authentication process

	FHIR map (or gap)	CDISC	Comment
Study ID or Number	ResearchStudy.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().partOf.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier	/GTP/Study/@ID	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 Observation is aware of its relevance to the Study.
Study Name	ResearchStudy.title 0..1 string	ResearchSubject.where(subject=Observation.subject).study.resolve()partOf.resolve().title Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().title	/GTP/Study/@Name	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 Observation is aware of its relevance to the Study.
Transmission Type	Determine from type of call to service (requesting all data vs incremental data - e.g. filtering by _lastUpdated). NOTE: If data are not persisted between FHIR and LAB, cannot do incremental data processing (due to lack of delta detection).	/GTP/Study/@TransmissionType	If the data is being 'pushed' in a message, this could also be conveyed in the MessageHeader.event
Study Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/TransactionType	This would be conveyed using a transaction Bundle - specifically the Bundle.entry.request.method
Site ID or Number	ResearchStudy.site 0..* Reference	ResearchSubject.where(subject=Observation.subject).study.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().identifier	/GTP/Study/Site/@ID	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 Observation is aware of its relevance to the Study.
Site Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Investigator ID or Number	Practitioner.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().identifier	/GTP/Study/Site/Investigator/@ID	Will need to decide which id to expose or may need to map to one recognized by the sponsor. If you want the PI for the overall study rather than just for the site associated with the Observation, you'll need to traverse the partOf.resolve() from the study-specific ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Investigator Name	Practitioner.name 0..* HumanName	ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().name.text Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().name.text	/GTP/Study/Site/Investigator/@Name	Will need to decide which name to expose if there are multiples. Can also extract the prefix, given and family names if text isn't specified. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Investigator Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/Investigator/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Screen ID or Number	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	/GTP/Study/Site/Investigator/Subject/ScreenID	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Subject ID or Number	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	/GTP/Study/Site/Investigator/Subject/SubjectID	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Spare subject level ID or Number	ResearchSubject.identifier 0..* Identifier	ResearchSubject.where(subject=Observation.subject).identifier	/GTP/Study/Site/Investigator/Subject/SpareSubjectID	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Observation. Use the identifier.type to differentiate subject identifiers. No standard way to decide which subject identifier to use. Also no standard way to differentiate subject id from screening id from spare subject id.
Subject Sex	Patient.gender 0..1 code Binding: AdministrativeGender required	Observation.subject.resolve().gender	/GTP/Study/Site/Investigator/Subject/Sex/@Value	Consider whether patient personal information is required for sponsor to perform patient reconciliation. If not, do not send this data element. The US-core birth-sex extension (if it is present) may be more consistently populated than Patient.gender. If patient gender is sent, the values must be mapped from the FHIR vocabulary to the LAB standard: male -> M female -> F other -> U unknown -> U
Subject Sex Code List ID	For FHIR, the administrative gender code list is fixed, so no need to send it in the instance. If there's a need to convey alternate gender codes, then those would appear either as Observation values or as extension values on Patient (the former for clinical information, the latter for administrative purposes). In either event, the code would be in CodeableConcept.coding which allows identifying both the code system and (if relevant), the version	/GTP/Study/Site/Investigator/Subject/Sex/@CodeListID
Subject Race	There's an US-core extension (us-core-race) for capturing this in the U.S. and the possibility that other countries will define their own extensions. Note that this is for administrative, not clinical purposes. Genetic heritage would typically be captured as an Observation	/GTP/Study/Site/Investigator/Subject/Race/@Value	Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element. If patient race is sent, use the us-core-race extension in FHIR.
Subject Race Code List ID	Race, whether captured as an extension or observation value is generally a CodeableConcept allowing capturing both code system and (if relevant) version. Race is highly variable from country to country (both whether it's allowed and how it's coded), so there's no standard element for this in the core spec.	/GTP/Study/Site/Investigator/Subject/Race/@CodeListID
Subject Initials	Patient.name 0..* HumanName	ResearchSubject.where(subject=Observation.subject).individual.resolve().name.text	/GTP/Study/Site/Investigator/Subject/Confidential/@Initials	Note that name.text will typically contain the full name, but can contain initials only. If the full name is present, initials can be extracted by looking at the given and family name components and converting to initials Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element. If required, be sure to send only the initials, derived from the name.
Subject Date Of Birth	Patient.birthDate 0..1 date	ResearchSubject.where(subject=Observation.subject).individual.resolve().birthDate	/GTP/Study/Site/Investigator/Subject/Confidential/@Birthdate	Note that precision can vary (YYYY, YYYY-MM or YYYY-MM-DD) Consider whether patient personal information is required for the sponsor to perform patient reconciliation. If not, do not send this data element.
Visit ID or Number	Encounter.identifier 0..* Identifier	Observation.encounter.resolve().identifier	/GTP/Study/Site/Investigator/Subject/Visit/@ID	No standard way to decide which identifier to use if multiples are present
Visit Name	In practice, visit name would be the ActivityDefinition.title for the activity in the protocol associated with the encounter. There is no standard extension for this link (though one will be defined). Most clinical systems won't actually capture this, so the determination will need to be made at time of data extraction based on the protocol	/GTP/Study/Site/Investigator/Subject/Visit/@Name	See LB mapping comment
Visit Type	This is essentially whether the visit is tied to a particular activity within the PlanDefinition (study protocol) or not. Given that in non-study-specific systems, there won't typically be a linkage even when the encounter is driven by the study, this will generally need to be populated algorithmically on extension	/GTP/Study/Site/Investigator/Subject/Visit/@Type	This could theoretically be distinguished by whether there was a link to a CarePlan activity or ActivityDefinition. Alternatively, you could use an extension or tag. (What's 'planned' for one study might be unplanned for another) This would be Encounter.reasonCode
Visit Type Modifier	Encounter.reasonCode 0..* CodeableConcept Binding: EncounterReason preferred	Observation.encounter.resolve().reasonCode	/GTP/Study/Site/Investigator/Subject/Visit/@TypeModifier	This would be Encounter.reasonCode
Subject Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/Investigator/Subject/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Accession ID or Number	Specimen.accessionIdentifier 0..1 Identifier	Observation.resolve().accessionIdentifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/@ID
Last Active Date and Time	FHIR allows capture meta.lastUpdated which reflects when the data last changed on the server in question, but would need to look at Provenance to see when data last changed on a particular system. This typically won't be available.	/GTP/Study/Site/Investigator/Subject/Visit/Accession/@LastActiveDateTime
Visit Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/Investigator/Subject/Visit/Accession/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Central Laboratory ID	Organization.identifier 0..* Identifier org-1	Observation.performer.resolve().identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@ID	Will need to look at identifier.type or identifier.system to know which identifier to use. In some cases, performer might be PractitionerRole, in which case, will need to map through PractitionerRole.organization. If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.
Central Laboratory Name	Organization.name 0..1 string org-1	Observation.performer.resolve().name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@Name	If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.
Specimen ID or Number	Specimen.identifier 0..* Identifier	Observation.specimen.resolve().identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/@ID	If there are multiple identifiers, need to look at identifier.system or identifier.type to determine
Actual Collection Date and Time	Specimen.collection.collectedDateTime 0..1 dateTime	Observation.specimen.resolve().collection.collectedDateTime	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@ActualCollectionDateTime	Most of the time there'll only be a single dateTime. If collected over a period of time (e.g. urine), use the end.
Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end
Planned Collection Time Elapsed	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).valueDuration	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsed	Will need to convert value + units into an ISO duration
Planned Collection Time Elapsed Description	Specimen.extension 0..* Extension	Observation.specimen.resolve().extension(cqf-relativeDateTime).valueReference.reference	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsedDescription	The event would be in extension('target').valueReference.display and the time would be in extension('offset').valueDuration value and unit.
Collection End Date and Time	Specimen.collection.collectedPeriod 0..1 Period	Observation.specimen.resolve().collection.collectedPeriod.end	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@CollectionEndDateTime
Received Date and Time	Specimen.receivedTime 0..1 dateTime	Observation.specimen.resolve().receivedTime	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@ReceivedDateTime
Specimen Condition	Specimen.condition 0..* CodeableConcept Binding: SpecimenCondition extensible	Observation.specimen.resolve().condition.coding.code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@SpecimenCondition	Will need to choose which coding to extract the code for
Investigator - Specimen Comment Source	Practitioner.identifier 0..* Identifier	Observation.specimen.resolve().note.author.resolve().where($thisisPractitioner).identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source	Note that practitioners can have multiple identifiers - use type or system to decide which identifier to expose
Investigator - Specimen Comment Text	Specimen.note 0..* Annotation	Observation.specimen.resolve().where($author.resolve()isPractitioner).note.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text
Lab - Specimen Comment Source	Observation.identifier 0..* Identifier	Observation.specimen.resolve().note.author.resolve().where($thisisOrganization).identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source	Note that organizations can have multiple identifiers - use type or system to decide which identifier to expose
Lab - Specimen Comment Text	Specimen.note 0..* Annotation	Observation.specimen.resolve().where($author.resolve() isOrganization).note.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text
Specimen Material ID	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@ID	If multiple codes are present, filter based on system
Specimen Material Name	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.display	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@Name	If multiple codes are present, filter based on system. Translation may be required
Specimen Material Code List ID	Specimen.type 0..1 CodeableConcept Binding: SpecimenType example	Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.system	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@CodeListID	If multiple codings are present, will need to decide which to use
Subject Age at Collection	If captured as an Observation, this would be in the ValueQuantity.code derived from the patient.birthDate(Observation.subject (ref:Patient.birthDate). If the full birthdate cannot be shared, due to country restrictions, use the birth year to derive age information. Due to lost accuracy in having only the year of birth, 'years' would be the default unit. As an alternative use the cqf-relativeTime extension on Patient.birthDate and convey as a relative time to study enrollment	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeAtCollection
Subject Age Units	If captured as an Observation, this would be in the ValueQuantity.code derived from the patient.birthDate(Observation.subject (ref:Patient.birthDate). If the full birthdate cannot be shared, due to country restrictions, use the birth year to derive age information. Due to lost accuracy in having only the year of birth, 'years' would be the default unit.	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeUnits
Fasting Status	Specimen.collection.fastingStatusCodeableConcept 0..1 CodeableConcept Binding: FastingStatus extensible	Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@FastingStatus	FHIR to CDISC mapping as follows: F -> Y; NF -> N; FNA -> N/A; NG -> Not Applicable (blank) If fastingStatusDuration is present and non-zero, that would also map to 'Y'. There are times where this can be inferred from the Observation.code.
Battery ID	DiagnosticReport.identifier 0..* Identifier	DiagnosticReport.identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@ID
Battery Name	DiagnosticReport.code 1..1 CodeableConcept Binding: DiagnosticReportCodes preferred	DiagnosticReport.code.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@Name
Battery Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Test Status	ServiceRequest.doNotPerform 0..1 boolean	Observation.basedOn.resolve().doNotPerform	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@Status	Multiple fields are required to populate this value per the standard. Use ServiceRequest.status and ServiceRequest.doNotPerform (doNotPerform will only be true if the test is not to be performed) to represent the test status. From these two fields, sponsors will need to translate to the CDISC test statuses: D - Done N - Not Performed X - Cancelled.
ServiceRequest.status 1..1 code Binding: ServiceRequestStatus required	Observation.basedon.resolve().status
Testing Date and Time	Observation.effectiveDateTime 0..1 dateTime	Observation.effectiveDateTime	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestingDateTime
Test Type	The normal transmission of data, via FHIR, is for study tests. If non-study test results are required (e.g., AdverseEvent follow-up), these would be obtained via a special request from the data provider. Alternatively, if the system requires this field to be populated, derive whether the test was for the study or not, use the ServiceRequest resource.	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestType	Differentiation would be whether the Observation was basedOn a particular activity in the CarePlan (scheduled) or tied to a particular ActivityDefinition (Study test)
Performing Laboratory ID	Organization.identifier 0..* Identifier org-1	Observation.performer.resolve().identifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@ID	Use "Organization/type" to pick the type of Organization that represents "Performing Lab"
Performing Laboratory Name	Organization.name 0..1 string org-1	Observation.performer.resolve().name	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@Name
Lab Test ID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system = 'Lab Test')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@ID	Since this is a codeable concept, there may be multiple codes for a test. The sponsor will have to determine which is the "lab's" code vs. "receiver's" code vs. others.
Lab Test Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.display	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@Name
Additional Test Description	Observation.note 0..* Annotation	Observation.note.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@AdditionalDescription	Not all notes will necessarily be appropriate to map here. Would need to decide whether to also bring across authors and dates and would need to combined multiple repetitions into a single string.
Receiver Test ID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where (system = [Recipient Test])	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@ID	Observation/code/coding/system/@value ("system" element used to designate the type of code that is being represented (in this case the "ReceiverTest") by the "code" element)
Receiver Test Name	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.display where (coding system = 'Recipient Test')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@Name
LOINC Code	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where (coding system = 'http://loinc.org')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@Value
LOINC Code List ID	Observation.code 1..1 CodeableConcept Binding: ObservationCode example	Observation.code.coding.where(system = 'http://loinc.org')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@CodeListID	This will always be 'LOINC'
Test Level Comments	Observation.extension 0..* Extension	Observation.note.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TestLevelComment	Will need to determine whether to also incude date and author.
Reported Result Status	Observation.status 1..1 code Binding: ObservationStatus required	Observation.status	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedResultStatus	This has two possible values: P for Preliminary and F for Final.
Alert Flag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where(system='Alert Flag')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@AlertFlag	The alert flag generated by the reference ranges applied and tied to the reported result. There are 9 alert flag values: LP - Low Panic LT - Low Telephone LN - Low Normal N - Normal HN - High Normal HT - High Telephone HP - High Panic AB - Abnormal and blank when not used. It may be necessary to translate from other interpretation codings.
Delta Flag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Delta Flag')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@DeltaFlag	The delta flag generated by the reference ranges applied and tied to the reported result. There are three delta flags: D+ for an increase in value D- for a decrease in value and blank for no flag. It may be necessary to translate from other interpretation codings.
Exclusion Flag	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Exclusion Flag')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ExclusionFlag	The exclusion flag generated by the reference ranges applied and tied to the reported result. There are four exclusion flag values: LX - Low Exclusion HX - High Exclusion EX - Excluded (for exclusions not falling under high or low) and blank for no flag. It may be necessary to translate from other
Blinding Flag	Observation.meta 0..1 Meta	Observation.meta.security.code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@BlindingFlag	A new code would likely be needed to specifically designate 'blinded'.
Reported Date and Time	Observation.issued 0..1 instant	Observation.issued	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedDateTime
Test Transaction Type	Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TransactionType	As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)
Toxicity Grade	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Toxicity Grade').code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@Value	If there are multiple possible systems, the sponsor will have to determine which interpretation corresponds to toxicity grade
Toxicity Grade Code List ID	Observation.interpretation 0..* CodeableConcept Binding: ObservationInterpretation extensible	Observation.interpretation.coding.where (system = 'Toxicity Grade')	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@CodeListID	May need to translate the URI to a CDISC Code List id
Reported Result Type (C=coded; N=numeric; T=text; R=range; G = GT; L = LT)	Determine from the field in which the result resides. valueCodeableConcept vs. valueQuantity vs. valueString Greater than and less than can be determined by valueQuantity.qualifier	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/@ResultType
Text Result	Observation.valueCodeableConcept 0..1 CodeableConcept obs-7	Observation.valueCodeableConcept.text	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@Value
Text Result Code List ID	Observation.valueCodeableConcept 0..1 CodeableConcept obs-7	Observation.valueCodeableConcept.coding.system	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@CodeListID	May need to convert from URI to CDISC-recognized 'ID'
Conventional Numeric Result	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value	If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.
Reported Numeric Result	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value
SI Numeric Result	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value	If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.
Conventional Numeric Result Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.
Reported Numeric Result Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value
SI Numeric Result Precision	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.value	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision	Determine the precision from the value. Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.
Conventional Reference Range Low	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.
Reported Reference Range Low	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Will need to combine value and unit into a string.
SI Reference Range Low	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.low.value Observation.referenceRange.low.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow	Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.
Conventional Reference Range High	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.
Reported Reference Range High	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Will need to combine value and unit into a string.
SI Reference Range High	Observation.referenceRange 0..* BackboneElement	Observation.referenceRange.high.value Observation.referenceRange.high.unit	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh	Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.
Conventional Units	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code Observation.valueQuantity.extension('PQ-translation').code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	If the reported units are not the same as conventional, can convey with the translation extension. Translation to CDISC terminology may be required.
Reported Units	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	This may require translation to CDISC terminology
SI Units	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.code Observation.valueQuantity.extensoin('PQ-translation').code	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value	If the reported units are not SI units, can convey with the translation extension. Translation to CDISC terminology may be required.
Conventional Units Code List ID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID
Reported Units Code List ID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID
SI Units Code List ID	Observation.valueQuantity 0..1 Quantity obs-7	Observation.valueQuantity.system	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID
Record Extension Type	Populate with a default value, depending on the type of data being transmitted. E.g., "BASE"
Result Class	In FHIR, the value will always be 'reported', with the ability to convey translations in an extension. Nothing will differentiate whether a translation is considered 'conventional' or not, so if there are multiple translations present and the receiver can't figure it out by looking, an additional extension may be necessary to differentiate. This can sometimes also be inferred from the Observation.code.	/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultClass/@Value
Model Version	Populate with a default value.	/GTP/@ModelVersion	The version of FHIR in use is conveyed using Resource.meta.profile
File Creation Date and Time	Pull from the message wrapper. (file creation date)	/GTP/@CreationDateTime	Bundle.timestamp
Transaction Type	No mitigation. If required, fill with a default value.	/GTP/TransactionType	As per study.transaction
Transmission Source ID	Pull from the message wrapper.	/GTP/TransmissionSource/@ID	MessageHeader.source.endpoint if using messaging, otherwise determined out of band based on sender authentication process
Transmission Source Name	Pull from the message wrapper.	/GTP/TransmissionSource/@Name	MessageHeader.source.name if using messaging, otherwise determined out of band based on sender authentication process

FHIR map (or gap)

CDISC

Comment

Label

Element

FHIRPath

LAB

Study ID or Number

ResearchStudy.identifier
0..* Identifier

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

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

/GTP/Study/@ID

Study Name

ResearchStudy.title
0..1 string

ResearchSubject.where(subject=Observation.subject).study.resolve()partOf.resolve().title

Observation.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().title

/GTP/Study/@Name

Transmission Type

/GTP/Study/@TransmissionType

If the data is being 'pushed' in a message, this could also be conveyed in the MessageHeader.event

Study Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/TransactionType

This would be conveyed using a transaction Bundle - specifically the Bundle.entry.request.method

Site ID or Number

ResearchStudy.site
0..* Reference

ResearchSubject.where(subject=Observation.subject).study.resolve().identifier

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

/GTP/Study/Site/@ID

Site Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Investigator ID or Number

Practitioner.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().identifier

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

/GTP/Study/Site/Investigator/@ID

Investigator Name

Practitioner.name
0..* HumanName

ResearchSubject.where(subject=Observation.subject).study.resolve().principleInvestigator.resolve().name.text

Observation.extension(workflow-researchstudy).valueReference.resolve().principleInvestigator.resolve().name.text

/GTP/Study/Site/Investigator/@Name

Investigator Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/Investigator/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Screen ID or Number

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

/GTP/Study/Site/Investigator/Subject/ScreenID

Subject ID or Number

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

/GTP/Study/Site/Investigator/Subject/SubjectID

Spare subject level ID or Number

ResearchSubject.identifier
0..* Identifier

ResearchSubject.where(subject=Observation.subject).identifier

/GTP/Study/Site/Investigator/Subject/SpareSubjectID

Subject Sex

Patient.gender
0..1 code
Binding: AdministrativeGender required

Observation.subject.resolve().gender

/GTP/Study/Site/Investigator/Subject/Sex/@Value

Subject Sex Code List ID

/GTP/Study/Site/Investigator/Subject/Sex/@CodeListID

Subject Race

/GTP/Study/Site/Investigator/Subject/Race/@Value

Subject Race Code List ID

/GTP/Study/Site/Investigator/Subject/Race/@CodeListID

Subject Initials

Patient.name
0..* HumanName

ResearchSubject.where(subject=Observation.subject).individual.resolve().name.text

/GTP/Study/Site/Investigator/Subject/Confidential/@Initials

Subject Date Of Birth

Patient.birthDate
0..1 date

ResearchSubject.where(subject=Observation.subject).individual.resolve().birthDate

/GTP/Study/Site/Investigator/Subject/Confidential/@Birthdate

Visit ID or Number

Encounter.identifier
0..* Identifier

Observation.encounter.resolve().identifier

/GTP/Study/Site/Investigator/Subject/Visit/@ID

No standard way to decide which identifier to use if multiples are present

Visit Name

/GTP/Study/Site/Investigator/Subject/Visit/@Name

See LB mapping comment

Visit Type

/GTP/Study/Site/Investigator/Subject/Visit/@Type

Visit Type Modifier

Encounter.reasonCode
0..* CodeableConcept
Binding: EncounterReason preferred

Observation.encounter.resolve().reasonCode

/GTP/Study/Site/Investigator/Subject/Visit/@TypeModifier

This would be Encounter.reasonCode

Subject Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/Investigator/Subject/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Accession ID or Number

Specimen.accessionIdentifier
0..1 Identifier

Observation.resolve().accessionIdentifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/@ID

Last Active Date and Time

/GTP/Study/Site/Investigator/Subject/Visit/Accession/@LastActiveDateTime

Visit Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/Investigator/Subject/Visit/Accession/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Central Laboratory ID

Organization.identifier
0..* Identifier org-1

Observation.performer.resolve().identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@ID

Central Laboratory Name

Organization.name
0..1 string org-1

Observation.performer.resolve().name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/CentralLab/@Name

If there are multiple performers that link to multiple organizations, converter will need to look at Organization.type or have other rules to decide amongst the candidates.

Specimen ID or Number

Specimen.identifier
0..* Identifier

Observation.specimen.resolve().identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/@ID

If there are multiple identifiers, need to look at identifier.system or identifier.type to determine

Actual Collection Date and Time

Specimen.collection.collectedDateTime
0..1 dateTime

Observation.specimen.resolve().collection.collectedDateTime

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@ActualCollectionDateTime

Most of the time there'll only be a single dateTime. If collected over a period of time (e.g. urine), use the end.

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.end

Planned Collection Time Elapsed

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).valueDuration

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsed

Will need to convert value + units into an ISO duration

Planned Collection Time Elapsed Description

Specimen.extension
0..* Extension

Observation.specimen.resolve().extension(cqf-relativeDateTime).valueReference.reference

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@PlannedCollectionTimeElapsedDescription

The event would be in extension('target').valueReference.display and the time would be in extension('offset').valueDuration value and unit.

Collection End Date and Time

Specimen.collection.collectedPeriod
0..1 Period

Observation.specimen.resolve().collection.collectedPeriod.end

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenCollection/@CollectionEndDateTime

Received Date and Time

Specimen.receivedTime
0..1 dateTime

Observation.specimen.resolve().receivedTime

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@ReceivedDateTime

Specimen Condition

Specimen.condition
0..* CodeableConcept
Binding: SpecimenCondition extensible

Observation.specimen.resolve().condition.coding.code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenTransport/@SpecimenCondition

Will need to choose which coding to extract the code for

Investigator - Specimen Comment Source

Practitioner.identifier
0..* Identifier

Observation.specimen.resolve().note.author.resolve().where($thisisPractitioner).identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source

Note that practitioners can have multiple identifiers - use type or system to decide which identifier to expose

Investigator - Specimen Comment Text

Specimen.note
0..* Annotation

Observation.specimen.resolve().where($author.resolve()isPractitioner).note.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text

Lab - Specimen Comment Source

Observation.identifier
0..* Identifier

Observation.specimen.resolve().note.author.resolve().where($thisisOrganization).identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Source

Note that organizations can have multiple identifiers - use type or system to decide which identifier to expose

Lab - Specimen Comment Text

Specimen.note
0..* Annotation

Observation.specimen.resolve().where($author.resolve() isOrganization).note.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenComment/@Text

Specimen Material ID

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@ID

If multiple codes are present, filter based on system

Specimen Material Name

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.display

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@Name

If multiple codes are present, filter based on system. Translation may be required

Specimen Material Code List ID

Specimen.type
0..1 CodeableConcept
Binding: SpecimenType example

Observation.specimen.resolve().where($author.resolve() isOrganization).type.coding.system

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SpecimenMaterial/@CodeListID

If multiple codings are present, will need to decide which to use

Subject Age at Collection

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeAtCollection

Subject Age Units

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@AgeUnits

Fasting Status

Specimen.collection.fastingStatusCodeableConcept
0..1 CodeableConcept
Binding: FastingStatus extensible

Observation.specimen.resolve().collection.fastingStatusCodeableConcept.coding.code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/SubjectAtCollection/@FastingStatus

Battery ID

DiagnosticReport.identifier
0..* Identifier

DiagnosticReport.identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@ID

Battery Name

DiagnosticReport.code
1..1 CodeableConcept
Binding: DiagnosticReportCodes preferred

DiagnosticReport.code.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/@Name

Battery Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Test Status

ServiceRequest.doNotPerform
0..1 boolean

Observation.basedOn.resolve().doNotPerform

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@Status

ServiceRequest.status
1..1 code
Binding: ServiceRequestStatus required

Observation.basedon.resolve().status

Testing Date and Time

Observation.effectiveDateTime
0..1 dateTime

Observation.effectiveDateTime

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestingDateTime

Test Type

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/@TestType

Differentiation would be whether the Observation was basedOn a particular activity in the CarePlan (scheduled) or tied to a particular ActivityDefinition (Study test)

Performing Laboratory ID

Organization.identifier
0..* Identifier org-1

Observation.performer.resolve().identifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@ID

Use "Organization/type" to pick the type of Organization that represents "Performing Lab"

Performing Laboratory Name

Organization.name
0..1 string org-1

Observation.performer.resolve().name

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/PerformingLab/@Name

Lab Test ID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where(system = 'Lab Test')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@ID

Since this is a codeable concept, there may be multiple codes for a test. The sponsor will have to determine which is the "lab's" code vs. "receiver's" code vs. others.

Lab Test Name

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.display

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@Name

Additional Test Description

Observation.note
0..* Annotation

Observation.note.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LabTest/@AdditionalDescription

Not all notes will necessarily be appropriate to map here. Would need to decide whether to also bring across authors and dates and would need to combined multiple repetitions into a single string.

Receiver Test ID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where (system = [Recipient Test])

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@ID

Observation/code/coding/system/@value ("system" element used to designate the type of code that is being represented (in this case the "ReceiverTest") by the "code" element)

Receiver Test Name

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.display where (coding system = 'Recipient Test')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/ReceiverTest/@Name

LOINC Code

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where (coding system = 'http://loinc.org')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@Value

LOINC Code List ID

Observation.code
1..1 CodeableConcept
Binding: ObservationCode example

Observation.code.coding.where(system = 'http://loinc.org')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/LOINCTestCode/@CodeListID

This will always be 'LOINC'

Test Level Comments

Observation.extension
0..* Extension

Observation.note.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TestLevelComment

Will need to determine whether to also incude date and author.

Reported Result Status

Observation.status
1..1 code
Binding: ObservationStatus required

Observation.status

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedResultStatus

This has two possible values: P for Preliminary and F for Final.

Alert Flag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where(system='Alert Flag')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@AlertFlag

Delta Flag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Delta Flag')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@DeltaFlag

Exclusion Flag

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Exclusion Flag')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ExclusionFlag

Blinding Flag

Observation.meta
0..1 Meta

Observation.meta.security.code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@BlindingFlag

A new code would likely be needed to specifically designate 'blinded'.

Reported Date and Time

Observation.issued
0..1 instant

Observation.issued

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/@ReportedDateTime

Test Transaction Type

Determining whether transactions are insert or update is a task for the data consumer. (NOTE: This requires persistent storage to compare current data with data in the incoming file)

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/TransactionType

As per study transaction type (not clear why it happens at both levels - what would it mean to 'delete' at the study level and 'update at the site level?)

Toxicity Grade

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Toxicity Grade').code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@Value

If there are multiple possible systems, the sponsor will have to determine which interpretation corresponds to toxicity grade

Toxicity Grade Code List ID

Observation.interpretation
0..* CodeableConcept
Binding: ObservationInterpretation extensible

Observation.interpretation.coding.where (system = 'Toxicity Grade')

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/ToxicityGrade/@CodeListID

May need to translate the URI to a CDISC Code List id

Reported Result Type (C=coded; N=numeric; T=text; R=range; G = GT; L = LT)

Determine from the field in which the result resides. valueCodeableConcept vs. valueQuantity vs. valueString Greater than and less than can be determined by valueQuantity.qualifier

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/@ResultType

Text Result

Observation.valueCodeableConcept
0..1 CodeableConcept obs-7

Observation.valueCodeableConcept.text

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@Value

Text Result Code List ID

Observation.valueCodeableConcept
0..1 CodeableConcept obs-7

Observation.valueCodeableConcept.coding.system

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/TextResult/@CodeListID

May need to convert from URI to CDISC-recognized 'ID'

Conventional Numeric Result

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

If the reported result isn't in conventional units, can use the PQ-translation extension to convey a translation.

Reported Numeric Result

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

SI Numeric Result

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Value

If the reported result isn't in SI units, can use the PQ-translation extension to convey a translation.

Conventional Numeric Result Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Reported Numeric Result Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Determine the precision from the value.

Precision is implicitly determined from the attribute Observation/valueQuantity/value/@value

SI Numeric Result Precision

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.value

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/NumericResult/@Precision

Conventional Reference Range Low

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.

Reported Reference Range Low

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Will need to combine value and unit into a string.

SI Reference Range Low

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.low.value

Observation.referenceRange.low.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeLow

Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.

Conventional Reference Range High

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Will need to combine value and unit into a string. If the reported units aren't 'conventional, can use the PQ-translation extension on Quantity to convey a translation.

Reported Reference Range High

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Will need to combine value and unit into a string.

SI Reference Range High

Observation.referenceRange
0..* BackboneElement

Observation.referenceRange.high.value

Observation.referenceRange.high.unit

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultReferenceRange/@ReferenceRangeHigh

Will need to combine value and unit into a string. If the reported units aren't SI, can use the PQ-translation extension on Quantity to convey a translation.

Conventional Units

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

Observation.valueQuantity.extension('PQ-translation').code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

If the reported units are not the same as conventional, can convey with the translation extension. Translation to CDISC terminology may be required.

Reported Units

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

This may require translation to CDISC terminology

SI Units

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.code

Observation.valueQuantity.extensoin('PQ-translation').code

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@Value

If the reported units are not SI units, can convey with the translation extension. Translation to CDISC terminology may be required.

Conventional Units Code List ID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

Reported Units Code List ID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

SI Units Code List ID

Observation.valueQuantity
0..1 Quantity obs-7

Observation.valueQuantity.system

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultUnits/@CodeListID

Record Extension Type

Populate with a default value, depending on the type of data being transmitted.

E.g., "BASE"

Result Class

/GTP/Study/Site/Investigator/Subject/Visit/Accession/BaseSpecimen/BaseBattery/BaseTest/BaseResult/SingleResult/ResultClass/@Value

Model Version

Populate with a default value.

/GTP/@ModelVersion

The version of FHIR in use is conveyed using Resource.meta.profile

File Creation Date and Time

Pull from the message wrapper. (file creation date)

/GTP/@CreationDateTime

Bundle.timestamp

Transaction Type

No mitigation. If required, fill with a default value.

/GTP/TransactionType

As per study.transaction

Transmission Source ID

Pull from the message wrapper.

/GTP/TransmissionSource/@ID

MessageHeader.source.endpoint if using messaging, otherwise determined out of band based on sender authentication process

Transmission Source Name

Pull from the message wrapper.

/GTP/TransmissionSource/@Name

MessageHeader.source.name if using messaging, otherwise determined out of band based on sender authentication process