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A WorkflowDef defines an automated workflow for in a study.
| Element Name | WorkflowDef |
|---|
| Parent Elements | MetaDataVersion |
|---|
| Element XPath(s) | /ODM/Study/MetaDataVersion/WorkflowDef |
|---|
| Element Textual Value | None |
|---|
| Attributes | OID, Name |
|---|
| Child Elements | (Description?, WorkflowStart, (Transition?, Branching?)+, WorkflowEnd+) |
|---|
| Usage/Business Rules | - Other Information:
Workflows can be nested, by referencing a StudyEventGroupDef that references another WorkflowDef element. In this way a workflow can consist of several subworkflows. A workflow for the study as a whole will typically be described in a WorkflowDef referenced from the Protocol element. Workflows that are valid for a "study cell" (as described in the SDTMIG) will be described in a WorkflowDef referenced by a StudyEventGroupDef representing a study cell (i.e., ArmOID and EpochOID are populated). - References to the SDTMIG correspond to the SDTMIG v3.3, last Production version at the release of the ODMv2 Specifications.
Workflows that are valid for a study element (as described in the SDTMIG) will be described in a WorkflowDef referenced by a StudyEventGroupDef without ArmOID and EpochOID populated, and by a "parent" StudyEventGroupDef representing a study cell (i.e., ArmOID and EpochOID are populated.
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|---|
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
|---|
| OID | oid | Required | Unique identifier for the workflow. | - The OID attribute value must be unique within the Study.
|
| Name | name | Required | Human readable label for the workflow. | - The Name attribute value must be unique within the Study.
|
Workflows can be nested, by referencing a StudyEventGroupDef that references another WorkflowDef element. In this way a workflow can consist of several sub-workflows.
A workflow for the study as a whole will typically be described in a WorkflowDef that is referenced from the Protocol element. Workflows that are valid for a "study cell" (as described in the SDTM-IG), will be described in a WorkflowDef that is referenced by a StudyEventGroupDef representing a "study cell", i.e. with the ArmOID and EpochOID being populated. Workflows that are valid for a "study element" (as described in the SDTM-IG) will be described in a WorkflowDef that is referenced by a StudyEventGroupDef without ArmOID and EpochOID populated, and referenced by a "parent" StudyEventGroupDef representing a "study cell", i.e. with the ArmOID and EpochOID being populated.
Example:
Physio- or Underwater therapy workflow