StructureDefinition-pqcmc-stability-study-interval-report

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-stability-study-interval-report
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-stability-study-interval-report
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameStabilityStudyIntervalReport
titleStability Study Interval Report
date2023-07-17T03:00:13+00:00
descriptionBatch or lot stability testing to ensure that pharmaceutical products continue to meet the product specification or determine the expiry period.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeDiagnosticReport
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/DiagnosticReport
Usages
Name Flags Card. Type Description & Constraints doco
. . DiagnosticReport DiagnosticReport
. . . meta
. . . . profile S ..1
. . . Slices for extension 2.. Slice: Unordered, Open by value:url
. . . studyInterval S 1..1 (Complex) Study Interval
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-timePoint-extension
. . . qualitySpecification S 1..1 (Complex) Specification and Specification Version
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-quality-specification-extension
. . . substudy-additional-info S 0..* markdown Sub-Study Additional
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension
. . . identifier S ..1 optional user designated identifier
. . . status S Status of the batch analysis
. . . code S Name for this study interval analysis.
. . . . coding .. 0
. . . . text S 1..
. . . subject S 1.. Reference (Drug Product Manufactured Instance | Drug Substance Manufactured Batch) A single medication batch-lot or a single subtance batch-lot
. . . performer S 1..1 Reference (Manufacturing and/or Test Site Organization) Test Site
. . . result S Reference (Result Observation)

doco Documentation for this format

Produced 08 Sep 2023