-
Type:
Change Request
-
Resolution: Persuasive with Modification
-
Priority:
Medium
-
FHIR Core (FHIR)
-
R5
-
Clinical Decision Support
-
DomainResource
-
-
Floyd Eisenberg/Kensaku Kawamoto: 19-0-0
-
Enhancement
-
Compatible, substantive
Request to add subject[x] reference to the MedicinalProductDefinition and SubstanceDefinition resource.
In PQ/CMC project, we are leveraging PlanDefinition for a Drug Product and Drug Substance quality specification. A Quality Specification is a series of tests that will be performed on a drug product or a drug substance where each test has set of acceptance criteria defined in the specification.