| Element Name | Study |
|---|---|
| Parent Elements | ODM |
| Element XPath(s) | /ODM/Study |
| Element Textual Value | None |
| Attributes | OID, StudyName, ProtocolName, VersionID, VersionName, Status |
| Child Elements | (Description?, MetaDataVersion*) |
| Usage/Business Rules |
|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the study. | |
| StudyName | name | Required | Sponsoring organization's internal name for the study. If no internal name is available, the value is expected to be the same value as ProtocolName. | |
| ProtocolName | name | Required | Protocol identifier or protocol number assigned to the study. It is used by the regulatory authority or clinical trial registry. | |
| VersionID | name | Optional | Identifier for the specific version of the study in the source system that the enclosed Study element metadata refers to. | |
| VersionName | name | Optional | Short descriptive label for the version of the study, e.g. "Initial go live" when VersionID = "<study version ID for Initial go live>". VersionName may be provided when a VersionID is provided. | VersionName may not be provided when a VersionID is not provided. |
| Status | name | Optional | Represents the workflow status for the version of the study with content included in the enclosed Study element metadata. Status values can be different in each system and may have specific meaning within each system, e.g. a "Production" version of a study in a particular source system may be non-editable and editable in a different source system. If no VersionID is provided, Status refers to the status of the Study as a whole. |
This element collects static structural information about an individual study.
StudyName is the internal name of the study used by the sponsoring organization. If no StudyName is available, use the same value as ProtocolName.
ProtocolName is the protocol identifier or protocol number assigned to the study.
VersionID as an identifier for the specific version of the study who's contents are within the Study element.
VersionName is a short descriptive label that may be provided when a VersionID is given.
Status is the workflow status for the version of the study who's contents are within the Study element. Status values can be different in each system and may have specific meanings within each system. If no VersionID is provided, the Status refers to the status of the Study as a whole.