Open BSnoeijerCD opened 1 month ago
@dih-cdisc I've updated the API specs in the release-3-6-0 branch in both usdm_api and DDF-RA to:
Identifier
class - copied from StudyIdentifier
and then:
studyIdentifier
to text
identifierScope
to scope
instanceType
StudyIdentifier
class to:
Identifier
instead of the base modelstudyIdentifier
and identifierScope
ReferenceIdentifier
class as a copy of the updated StudyIdentifier
class and
type
as Code
instanceType
StudyVersion
to:
referenceIdentifiers
as a copy of studyIdentifiers
, updating name and classstudyIdentifiers
required (removed = []
)Let me know if I missed anything...
Pediatric investigational plan number needs to be addressed. It is more a reference than an identifier. See EMA template https://www.ema.europa.eu/en/documents/template-form/paediatric-investigation-plan-pip-key-elements-guidance_en.pdf See feature ticket #420