A WorkflowDef defines an automated workflow for a study.

Element NameWorkflowDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/WorkflowDef 
Element Textual ValueNone
AttributesOID, 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.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the workflow.
  • The OID attribute value must be unique within the Study.
NamenameRequiredHuman readable label for the workflow. 
  • The Name attribute value must be unique within the Study.

Example: Workflow Branching


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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