HL7.FHIR.UV.CDISC-MAPPING\Procedures

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

Procedures

Procedures, in FHIR, use the Procedure resource. However, like Observations, the notion of Procedure is quite broad. It includes counseling, education and physio-therapy as well as more traditional concepts such as surgery. One area of interest relevant to CDISC mapping that has not yet been decided in the FHIR standard is how best to handle the ordering and administration of non-drug therapies that involve the notion of 'dose' - for example radiation, light therapy, etc. Options being considered include expanding the scope of the Medication resources, adding dose elements or extensions to Procedure, or defining a separate set of resources. Because this area is not yet settled, no mappings are provided for the dose-relevant elements.

In some cases, procedure information may be captured only in document form (as DocumentReferences) or as the associated Encounter. Because of the limited metadata available in these, no mappings are provided.

PR Mappings

Guidance on interpreting the table can be found here.

CDISC	FHIR map (or gap)	Comment
Study ID or Number	STUDYID	STUDYID	ResearchStudy.identifier	ResearchSubject.where(subject=Observation.subject).study.resolve().partOf.resolve().identifier.value Procedure.extension(workflow-researchstudy).valueReference.resolve().partOf.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Study Site ID	SITEID	DM.SITEID	ResearchStudy.site	ResearchSubject.where(subject=Observation.subject).study.resolve().identifier.value Procedure.extension(workflow-researchstudy).valueReference.resolve().identifier.value	Mapping is based on presumption that research subject will be tied to site-specific ResearchStudy, which will then be part of overall ResearchStudy. The path using the extension will only exist if the system maintaining the Observation is aware of its relevance to the Study.
Subject ID for the Study	SUBJID	DM.SUBJID	ResearchSubject.identifier	ResearchSubject.where(individual=Procedure.subject).identifier.value	Study subject is found by finding the StudySubject that corresponds to the same Patient and ResearchStudy as the Procedure. No standard way to decide which subject identifier to use
Any Procedures Performed	PRYN	(Y/N)	This likely to be a Questionnaire question than something that would directly be captured in a record. It could be the answer to an Observation, but even then it would be qualified by type and time-range (procedure covers education, massage, cognitive therapy and various other data)
Procedure Category	PRCAT	PRCAT	Procedure.category	Procedure.category	FHIR doesn't have 2 distinct category levels. Instead, Procedure.category repeats. The option exists to have as many categorizations with whatever axes and granularities needed or desired. When mapping data to a particular study, it would be necessary to decide what category values best correspond to CAT vs. SCAT.
Procedure Subcategory	PRSCAT	PRSCAT	Procedure.category	Procedure.category	FHIR doesn't have 2 distinct category levels. Instead, Procedure.category repeats. The option exists to have as many categorizations with whatever axes and granularities needed or desired. When mapping data to a particular study, it would be necessary to decide what category values best correspond to CAT vs. SCAT.
Procedure Sponsor Defined Identifier	PRSPID	PRSPID	Procedure.identifier	Procedure.identifier
Report name of Procedure	PRTRT	PRTRT	Procedure.code	Procedure.code.coding.display; Procedure.code.text	The name as expressed by or displayed to the user goes in code.text. The name associated with the selected code goes in code.coding.display.
Standardized Procedure Name	PRDECOD	PRDECOD	Procedure.code	Procedure.code	Define and review standardized coding schema with coding translations are conducted by the sponsor. PRDECOD is the dictionary or the sponsor-defined standardized text description of PRTRT, or the modified topic variable (PRMODIFY), if applicable. This means it is the standardized term for the procedure.
Modified Procedure Name	PRMODIFY	PRMODIFY	Coding translations are conducted by the sponsor. In FHIR, there's no need to modify the PRTERM. The text which was actually saw/typed (errors and all) is present and the various codes encoding it and the display names for those codes. If there was a need to capture a corrected text that was submitted to a post-coding process, that would be an extension
Procedure Prespecified	PRPRESP	PRPRESP	This likely to be a Questionnaire question than something that would directly be captured in a record. This could possibly be an extension on the Procedure/MedicationAdministration/MedicationStatement.
Procedure Occurrence	PROCCUR	PROCCUR	Procedure.status	Procedure.status	Coding translations are left to the sponsor. Status of 'not-done', 'entered-in-error' would indicate that it didn't happen, 'active', 'in-progress', 'on-hold', 'completed' would indicate that it did. 'stopped' would indicate that it started, but was abnormally terminated - where that should go depends on the study's definition of 'occur'.
Procedure Reason for Occur Value	PRREASOC	SUPPPR.QVAL	Procedure.reasonCode	Procedure.reasonCode	Note that reasonReference would need to be turned into a code or string. Reason[x] indicates reason for doing the procedure; statusReason when status=not-done would be reason for non-occurrence
Procedure.reasonReference	Procedure.reasonReference
Procedure.statusReason	Procedure.statusReason
Procedure Reason NOT Done	PRREASND	PRREASND	Procedure.statusReason	Procedure.statusReason.where(%resource.status IN {'not-done'\| 'stopped'})
Prior Procedure	PRPRIOR	PRSTRTPT; PRSTRF	This is not expect to receive from the site. This would be handled as an extension on the extension that ties the procedure to the study (though it can also be determined just by looking at the respective dates). (This assertion would be specific to the study link.)
Procedure Start Date	PRSTDAT	PRSTDTC	Procedure.performed	Procedure.performedDateTime Procedure.performedPeriod.start Procedure.performedRange.low	PerformedString and performedRange don't allow exact mappings (the latter indicates uncertainty about timing)
Ongoing Procedure	PRONGO	PRENRTPT; PRENRF	Procedure.status	Procedure.status	This supports the necessity of separating procedures and medication. An example of ongoing procedure, "hemodialysis with frequency of three times a week". If the status is 'in-progress'/'active', then it's ongoing. Note that MedicationAdministration reflects a single administration, so it would only be 'ongoing' until the IV is turned off or the rate is adjusted.
Procedure End Date	PRENDAT	PRENDTC	Procedure.performed	Procedure.performedDateTime Procedure.performedPeriod.start Procedure.performedRange.high	PerformedString and performedRange don't allow exact mappings (the latter indicates uncertainty about timing)
Procedure Indication	PRINDC	PRINDC	Procedure.reasonCode	Procedure.reasonCode	Note that reasonReference would need to be turned into a code or string.
Procedure.reasonReference	Procedure.reasonReference
Related AdverseEvent ID	PRAENO		AdverseEvent.identifier	Procedure.reasonReference.resolve().where(type='AdverseEvent').identifier
Related Medical History Event ID	PRMHNO		If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping.
Procedure Dose Description	PRDOSTXT		If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping.
Procedure Dose Unit	PRDOSU	PRDOSU	If FHIR IDs are used for RELREC, then the sponsor should evaluate its use case as necessary prior to mapping.
Procedure Frequency per Interval	PRDOSFRQ		Procedure.occurrenceTiming	Procedure.occurrenceTiming.repeat.frequency
Procedure Route of Administration	PRROUTE	PRROUTE	This is a known gap. Procedure Dose interval does NOT exist for 'Procedure'.
Location of Procedure	PRLOC	PRLOC	Procedure.bodySite	Procedure.bodySite
Procedure Laterality	PRLAT	PRLAT	BodyStructure.locationQualifier	Procedure.extension(procedure-targetBodyStructure).valueReference.resolve().locationQualifier	This is frequently pre-coordinated into Procedure.bodySite. Multiple qualifiers are possible. Laterality will need to be recognized by code and/or system
Procedure Directionality	PRDIR	PRDIR	BodyStructure.locationQualifier	Procedure.extension(procedure-targetBodyStructure).valueReference.resolve().locationQualifier	This is frequently pre-coordinated into Procedure.bodySite. Multiple qualifiers are possible. Directionality will need to be recognized by code and/or system
Procedure Portion or Totality	PRPORTOT	PRPORTOT	Typically this would be pre-coordinated into Procedure.code and would be captured in dosage instructions text for medications. If captured as a separate element, if would need to be an extension.
Procedure Fasting Status	PRFAST	PRFAST	This would be handled as an extension. Could propose as standard extension. Probably not relevant for MedicationStatement
Procedure Intended Dose Regimen	PRDOSRGM	PRDOSRGM	An administration could be based on more than one thing (recommendation, plan, order) and in theory the intended dose would be different for each.
Procedure Adjusted	PRDOSADJ		This would be handled as an extension. Would appear on Procedure/MedicationAdministration/MedicationStatement.basedOn. Might consider proposing it as a standard extension.
Reason for Procedure Adjustment	PRADJ	PRADJ	This would be handled as an extension. Would appear on Procedure/MedicationAdministration/MedicationStatement.basedOn. Might consider proposing it as a standard extension.
Completed Procedure	PRTRTCMP	SUPPPR.QVAL	Not all potential mapping/FHIR resources/attributes will be addressed in this implementation guide. All data requires review and analysis to ensure the data is relevant and understood.
Procedure Interrupted	PRITRPYN		Procedure.status	Procedure.status	If something is currently interrupted, the status would either be on-hold or stopped. If there was a temporary interruption and the procedure has since resumed or completed, the only way to detect the interruption would be an extension or to review the history.
Reason Procedure Interrupted	PRITRPRS	SUPPPR.QVAL	Procedure.statusReason	Procedure.statusReason	If the status is on-hold or stopped, statusReason would convey the reason. If there was a temporary interruption and the procedure has since resumed or completed, the only way to detect the interruption would be an extension or to review the history.
Procedure Interruption Duration	PRCINTD	SUPPPR.QVAL	This would have to be an extension. Typically, you'd just look at history to see when something was suspended, then resumed.
Procedure Interruption Duration Units	PRCINTDU	SUPPPR.QVAL	This would have to be part of the previous extension. Typically, reviewing the history of the procedure will indicate if it was suspended and then resumed.
Procedure Lowest Level Term	PRLLT	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain many codings and at various levels of granularity. Granularity will be determined by reviewing the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure Lowest Level Term Code	PRLLTCD	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure Preferred Term Code	PRPTCD	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure High Level Term	PRHLT	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure High Level Term Code	PRHLTCD	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure High Level Group Term	PRHLGT	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
Procedure High Level Group Term Code	PRHLGTCD	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
PR Primary System Organ Class	PRSOC	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication
PR primary System Organ Class Code	PRSOCCD	SUPPPR.QVAL	Procedure.code	Procedure.code	Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR. Procedure.code and Medication[x].medicationCode\|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

CDISC

FHIR map (or gap)

Comment

Name

CDASH

SDTM

Element

FHIRPath

Study ID or Number

STUDYID

ResearchStudy.identifier

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

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

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

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

Study Site ID

SITEID

DM.SITEID

ResearchStudy.site

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

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

Subject ID for the Study

SUBJID

DM.SUBJID

ResearchSubject.identifier

ResearchSubject.where(individual=Procedure.subject).identifier.value

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

No standard way to decide which subject identifier to use

Any Procedures Performed

PRYN

(Y/N)

This likely to be a Questionnaire question than something that would directly be captured in a record. It could be the answer to an Observation, but even then it would be qualified by type and time-range (procedure covers education, massage, cognitive therapy and various other data)

Procedure Category

PRCAT

Procedure.category

FHIR doesn't have 2 distinct category levels. Instead, Procedure.category repeats. The option exists to have as many categorizations with whatever axes and granularities needed or desired. When mapping data to a particular study, it would be necessary to decide what category values best correspond to CAT vs. SCAT.

Procedure Subcategory

PRSCAT

Procedure.category

Procedure Sponsor Defined Identifier

PRSPID

Procedure.identifier

Report name of Procedure

PRTRT

Procedure.code

Procedure.code.coding.display; Procedure.code.text

The name as expressed by or displayed to the user goes in code.text. The name associated with the selected code goes in code.coding.display.

Standardized Procedure Name

PRDECOD

Procedure.code

Define and review standardized coding schema with coding translations are conducted by the sponsor.

PRDECOD is the dictionary or the sponsor-defined standardized text description of PRTRT, or the modified topic variable (PRMODIFY), if applicable. This means it is the standardized term for the procedure.

Modified Procedure Name

PRMODIFY

Coding translations are conducted by the sponsor.

In FHIR, there's no need to modify the PRTERM. The text which was actually saw/typed (errors and all) is present and the various codes encoding it and the display names for those codes. If there was a need to capture a corrected text that was submitted to a post-coding process, that would be an extension

Procedure Prespecified

PRPRESP

This likely to be a Questionnaire question than something that would directly be captured in a record. This could possibly be an extension on the Procedure/MedicationAdministration/MedicationStatement.

Procedure Occurrence

PROCCUR

Procedure.status

Coding translations are left to the sponsor.

Status of 'not-done', 'entered-in-error' would indicate that it didn't happen, 'active', 'in-progress', 'on-hold', 'completed' would indicate that it did. 'stopped' would indicate that it started, but was abnormally terminated - where that should go depends on the study's definition of 'occur'.

Procedure Reason for Occur Value

PRREASOC

SUPPPR.QVAL

Procedure.reasonCode

Note that reasonReference would need to be turned into a code or string. Reason[x] indicates reason for doing the procedure; statusReason when status=not-done would be reason for non-occurrence

Procedure.reasonReference

Procedure.statusReason

Procedure Reason NOT Done

PRREASND

Procedure.statusReason

Procedure.statusReason.where(%resource.status IN {'not-done'| 'stopped'})

Prior Procedure

PRPRIOR

PRSTRTPT; PRSTRF

This is not expect to receive from the site.

This would be handled as an extension on the extension that ties the procedure to the study (though it can also be determined just by looking at the respective dates). (This assertion would be specific to the study link.)

Procedure Start Date

PRSTDAT

PRSTDTC

Procedure.performed

Procedure.performedDateTime

Procedure.performedPeriod.start

Procedure.performedRange.low

PerformedString and performedRange don't allow exact mappings (the latter indicates uncertainty about timing)

Ongoing Procedure

PRONGO

PRENRTPT; PRENRF

Procedure.status

This supports the necessity of separating procedures and medication.

An example of ongoing procedure, "hemodialysis with frequency of three times a week". If the status is 'in-progress'/'active', then it's ongoing. Note that MedicationAdministration reflects a single administration, so it would only be 'ongoing' until the IV is turned off or the rate is adjusted.

Procedure End Date

PRENDAT

PRENDTC

Procedure.performed

Procedure.performedDateTime Procedure.performedPeriod.start

Procedure.performedRange.high

PerformedString and performedRange don't allow exact mappings (the latter indicates uncertainty about timing)

Procedure Indication

PRINDC

Procedure.reasonCode

Note that reasonReference would need to be turned into a code or string.

Procedure.reasonReference

Related AdverseEvent ID

PRAENO

AdverseEvent.identifier

Procedure.reasonReference.resolve().where(type='AdverseEvent').identifier

Related Medical History Event ID

PRMHNO

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

Procedure Dose Description

PRDOSTXT

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

Procedure Dose Unit

PRDOSU

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

Procedure Frequency per Interval

PRDOSFRQ

Procedure.occurrenceTiming

Procedure.occurrenceTiming.repeat.frequency

Procedure Route of Administration

PRROUTE

This is a known gap. Procedure Dose interval does NOT exist for 'Procedure'.

Location of Procedure

PRLOC

Procedure.bodySite

Procedure Laterality

PRLAT

BodyStructure.locationQualifier

Procedure.extension(procedure-targetBodyStructure).valueReference.resolve().locationQualifier

This is frequently pre-coordinated into Procedure.bodySite. Multiple qualifiers are possible. Laterality will need to be recognized by code and/or system

Procedure Directionality

PRDIR

BodyStructure.locationQualifier

Procedure.extension(procedure-targetBodyStructure).valueReference.resolve().locationQualifier

This is frequently pre-coordinated into Procedure.bodySite. Multiple qualifiers are possible. Directionality will need to be recognized by code and/or system

Procedure Portion or Totality

PRPORTOT

Typically this would be pre-coordinated into Procedure.code and would be captured in dosage instructions text for medications. If captured as a separate element, if would need to be an extension.

Procedure Fasting Status

PRFAST

This would be handled as an extension. Could propose as standard extension. Probably not relevant for MedicationStatement

Procedure Intended Dose Regimen

PRDOSRGM

An administration could be based on more than one thing (recommendation, plan, order) and in theory the intended dose would be different for each.

Procedure Adjusted

PRDOSADJ

This would be handled as an extension. Would appear on Procedure/MedicationAdministration/MedicationStatement.basedOn. Might consider proposing it as a standard extension.

Reason for Procedure Adjustment

PRADJ

This would be handled as an extension. Would appear on Procedure/MedicationAdministration/MedicationStatement.basedOn. Might consider proposing it as a standard extension.

Completed Procedure

PRTRTCMP

SUPPPR.QVAL

Not all potential mapping/FHIR resources/attributes will be addressed in this implementation guide. All data requires review and analysis to ensure the data is relevant and understood.

Procedure Interrupted

PRITRPYN

Procedure.status

If something is currently interrupted, the status would either be on-hold or stopped. If there was a temporary interruption and the procedure has since resumed or completed, the only way to detect the interruption would be an extension or to review the history.

Reason Procedure Interrupted

PRITRPRS

SUPPPR.QVAL

Procedure.statusReason

If the status is on-hold or stopped, statusReason would convey the reason. If there was a temporary interruption and the procedure has since resumed or completed, the only way to detect the interruption would be an extension or to review the history.

Procedure Interruption Duration

PRCINTD

SUPPPR.QVAL

This would have to be an extension. Typically, you'd just look at history to see when something was suspended, then resumed.

Procedure Interruption Duration Units

PRCINTDU

SUPPPR.QVAL

This would have to be part of the previous extension. Typically, reviewing the history of the procedure will indicate if it was suspended and then resumed.

Procedure Lowest Level Term

PRLLT

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain many codings and at various levels of granularity. Granularity will be determined by reviewing the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure Lowest Level Term Code

PRLLTCD

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure Preferred Term Code

PRPTCD

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure High Level Term

PRHLT

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure High Level Term Code

PRHLTCD

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure High Level Group Term

PRHLGT

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

Procedure High Level Group Term Code

PRHLGTCD

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

PR Primary System Organ Class

PRSOC

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication

PR primary System Organ Class Code

PRSOCCD

SUPPPR.QVAL

Procedure.code

Procedure Code is performed by the sponsor - not expected to receive this from the site or FHIR.

Procedure.code and Medication[x].medicationCode|Medication.code can contain as many codings as you like at whatever granularity you like. You would distinguish what granularity it was by looking at the code system and/or having knowledge of the codes within the same code system (where one code system can express content at multiple granularities) Note: Not clear how many of these would be populated for a procedure rather than a medication