When creating a freeze or snapshot of a study, this represents a study design. Additional data is required to support USDM definition.
Metadata tied to study designs:
studyType (interventional or observational; select from codelist)
studyPhase (select from codelist)
therpeuticAreas (codelist driven but external, i.e., SNOMED; make it free text for now)
rationale
indications
objectives (endpoints are an element of objectives)
population
subtypes (can be selected from a codelist)
blindingSchema (can be selected from a codelist)
When creating a freeze or snapshot of a study, this represents a study design. Additional data is required to support USDM definition.
Metadata tied to study designs:
studyType (interventional or observational; select from codelist)
studyPhase (select from codelist)
therpeuticAreas (codelist driven but external, i.e., SNOMED; make it free text for now)
rationale
indications
objectives (endpoints are an element of objectives)
population
subtypes (can be selected from a codelist)
blindingSchema (can be selected from a codelist)