Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule |
---|---|---|---|---|
OID | oid | Required | Unique identifier for the study. | |
StudyName | name | Required | Sponsoring organization's internal name for the study. | |
ProtocolName | name | Required | Study name used by regulatory authority or clinical trial registry. | |
VersionID | name | Optional | Version identifier for the version of the study in the source system that the enclosed metadata is for. | |
VersionName | name | Optional | A name assigned to the version of the study, e.g. "Initial go live". | When a VersionID is provided, a VersionName may be provided |
Status | name | Optional | Status of the study version in the source system. Certain values may indicate certain behaviour in the source system, e.g. a "Production" version of a study in a particular source system may be non-editable. |
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