The metadata for a study is defined in a series of MetaDataVersion elements. Through this mechanism (multiple MetaDataVersion elements), the model supports the incremental deployment of "mid-study changes", and thus can handle a situation where multiple versions of the metadata are being used simultaneously (perhaps due to delays in IRB approval at various sites).
The way metadata versioning works is as follows. An individual Study element may contain multiple MetaDataVersions, reflecting one or more mid-stream study design changes. The initial version contains a full set of metadata. Each subsequent version typically contains only modified or newly added metadata elements, inheriting the previous metadata by an explicit reference. The same metadata elements in different versions will have the same OID. This approach is used to allow the older versions of the metadata to remain intact, while simultaneously providing a concise way to represent changes.
A metadata version defines the types of study structural elements, workflows, event timings, study event groups, study events, item groups, and items that form the study data.
| Element Name | MetaDataVersion |
|---|---|
| Parent Elements | Study |
| Element XPath(s) | /ODM/Study/MetaDataVersion |
| Element Textual Value | None |
| Attributes | OID, Name, CommentOID |
| Child Elements | (Description?, Include?, Standards?, AnnotatedCRF?, SupplementalDoc?, ValueListDef*, WhereClauseDef*, Protocol?, WorkflowDef*, StudyEventGroupDef*, StudyEventDef*, ItemGroupDef*, ItemDef*, CodeList*, ConditionDef*, MethodDef*, CommentDef*, Leaf*) |
| Usage/Business Rules |
|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier. | |
| Name | name | Required | MetaDataVersion name. | |
| CommentOID | oidref | Optional | Reference to a CommentDef element. | Must match a CommentDef/@OID child element. |
The Include element references a prior metadata version. This causes all the definitions in that prior metadata version to be automatically included in this one. Any of the included definitions can be replaced (overridden) by explicitly giving a new version of the definition (with the same OID) in the new metadata version. See Include for more information on how the Include element works. New definitions (with new OIDs) can be added in the same way.