WorkflowDef

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.

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 1:

Physio- or Underwater therapy workflow

Physio- or Underwater therapy Workflow Example

This example demonstrates a simple workflow where the patient is either undergoing physiotherapy or underwater therapy, or both. This example was automatically generated from a BPMN2-XML file using an XSLT stylesheet.

Visualization in BPMN2:

The ODM v2.0 representation, limited to the essential parts, is:

Workflow Branching

<odm:MetaDataVersion xmlns:odm="http://www.cdisc.org/ns/odm/v2.0" xmlns:bpmn="http://www.omg.org/spec/BPMN/20100524/MODEL" OID="MV.001" Name="MetaDataVersion 1">
	<!-- We model all the tasks as StudyEvents -->
	<!-- For a repeating task, we would set @Repeating='Yes' -->
	<!-- Start- and end-events of BPMN2 are not translated into StudyEvents -->
	<odm:WorkflowDef OID="WF.PHYSIO_UNDERWATER_THERAPY" Name="Workflow for Physio or Underwater Therapy">
		<odm:WorkflowStart StartOID="SE_0imo8x1"/>
		<odm:Transition OID="TR.SequenceFlow_00de882" Name="Transition from Visit 1 to Arm Branching" SourceOID="SE_0imo8x1" TargetOID="ExclusiveGateway_19rvqwk"/>
		<odm:Transition OID="TR.SequenceFlow_1sm9dlo" Name="Physio+underwater therapy arm" SourceOID="ExclusiveGateway_19rvqwk" TargetOID="ParallelGateway_12qduy7"/>
		<odm:Transition OID="TR.SequenceFlow_1hk2z8h" Name="Physiotherapy Arm" SourceOID="ExclusiveGateway_19rvqwk" TargetOID="SE_0m6x4je"/>
		<odm:Transition OID="TR.SequenceFlow_0z0iuws" Name="Underwater therapy arm" SourceOID="ExclusiveGateway_19rvqwk" TargetOID="SE_0stubbd"/>
		<odm:Transition OID="TR.SequenceFlow_0ao0p7m" Name="Transition from Physio+underwater therapy in parallel to Physiotherapy" SourceOID="ParallelGateway_12qduy7" TargetOID="SE_0m6x4je"/>
		<odm:Transition OID="TR.SequenceFlow_0dnupty" Name="Transition from Physio+underwater therapy in parallel to Underwater therapy" SourceOID="ParallelGateway_12qduy7" TargetOID="SE_0stubbd"/>
		<odm:Transition OID="TR.SequenceFlow_0mxsfta" Name="Transition from Physiotherapy to Visit 2: Evaluation" SourceOID="SE_0m6x4je" TargetOID="SE_0ltgyb8"/>
		<odm:Transition OID="TR.SequenceFlow_0ecqyq5" Name="Transition from Underwater therapy to Visit 2: Evaluation" SourceOID="SE_0stubbd" TargetOID="SE_0ltgyb8"/>
		<!--Branching definition-->
		<odm:Branching OID="ExclusiveGateway_19rvqwk" Name="Arm Branching" Type="Exclusive">
			<odm:TargetTransition TargetTransitionOID="TR.SequenceFlow_1sm9dlo" ConditionOID="COND.SequenceFlow_1sm9dlo"/>
			<odm:TargetTransition TargetTransitionOID="TR.SequenceFlow_1hk2z8h" ConditionOID="COND.SequenceFlow_1hk2z8h"/>
			<odm:TargetTransition TargetTransitionOID="TR.SequenceFlow_0z0iuws" ConditionOID="COND.SequenceFlow_0z0iuws"/>
		</odm:Branching>
		<odm:Branching OID="ParallelGateway_12qduy7" Name="Physio+underwater therapy in parallel" Type="Parallel">
			<!--Remark that there is no Condition reference for parallel execution-->
			<odm:TargetTransition TargetTransitionOID="TR.SequenceFlow_0ao0p7m"/>
			<!--Remark that there is no Condition reference for parallel execution-->
			<odm:TargetTransition TargetTransitionOID="TR.SequenceFlow_0dnupty"/>
		</odm:Branching>
		<odm:WorkflowEnd EndOID="SE_0ltgyb8"/>
	</odm:WorkflowDef>
	<!-- All visits are modeled as StudyEvent -->
	<odm:StudyEventDef OID="SE_0imo8x1" Name="Visit 1" Repeating="No" Type="Scheduled"/>
	<odm:StudyEventDef OID="SE_0m6x4je" Name="Physiotherapy" Repeating="No" Type="Scheduled"/>
	<odm:StudyEventDef OID="SE_0stubbd" Name="Underwater therapy" Repeating="No" Type="Scheduled"/>
	<odm:StudyEventDef OID="SE_0ltgyb8" Name="Visit 2: Evaluation" Repeating="No" Type="Scheduled"/>
	<!--Important: Note that BPMN2 does not have a mechanism to describe the condition in a machine-readable way-->
	<odm:ConditionDef OID="COND.SequenceFlow_1sm9dlo" Name="Condition for Physio+underwater therapy arm">
		<odm:Description>
			<odm:TranslatedText xml:lang="en" Type="text/plain">Condition for Physio+underwater therapy arm</odm:TranslatedText>
		</odm:Description>
	</odm:ConditionDef>
	<!--Important: Note that BPMN2 does not have a mechanism to describe the condition in a machine-readable way-->
	<odm:ConditionDef OID="COND.SequenceFlow_1hk2z8h" Name="Condition for Physiotherapy Arm">
		<odm:Description>
			<odm:TranslatedText xml:lang="en" Type="text/plain">Condition for Physiotherapy Arm</odm:TranslatedText>
		</odm:Description>
	</odm:ConditionDef>
	<!--Important: Note that BPMN2 does not have a mechanism to describe the condition in a machine-readable way-->
	<odm:ConditionDef OID="COND.SequenceFlow_0z0iuws" Name="Condition for Underwater therapy arm">
		<odm:Description>
			<odm:TranslatedText xml:lang="en" Type="text/plain">Condition for Underwater therapy arm</odm:TranslatedText>
		</odm:Description>
	</odm:ConditionDef>
</odm:MetaDataVersion>

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WorkflowDef