From ODM-SDM to SDTM
Prepared by Jozef Aerts - XML4Pharma
Presented by Kurt Hellstern, Hands-on GmbH
The ODM-SDM Extension
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SDM = Study Design Model
Draft v.1.0 published June 2011
Final expected October 2011
treats:
– Study Parameters
– Eligibility Criteria (inclusion-exclusion)
– Study Structure: arms, epochs, cells, segments, activities
– Workflows
– Timings
• SDM is an extension to ODM 1.3.1 => XML !
Elements in ODM and ODM-SDM
• In ODM:
<StudyEventDef …. …>
…..
</ StudyEventDef >
• In ODM-SDM:
<sdm:Summary>
….
</sdm:Summary>
Study Parameters
Maps 1:1 to SDTM Domain TS (Trial Summary)
Eligibility Criteria
Eligibility Criteria
• list of inclusion and exclusion criteria
• criterium itself (ConditionDef)
– human-readable (Description)
– machine-readable (FormalExpression)
• 1:1 mapping to SDTM domain TI
(Trial Inclusion/exclusion Criteria)
Study Structure
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Arms
Epochs
Cells
Segments
• Activities (new)
Study Structure in ODM Study Designer tool
Study Structure
• Content (XML) can be used to automatically
populate SDTM datasets
– TA (Trial Arms)
– TE (Trial Elements)
• Workflow Section (see further) enables to add:
– entry / exit criteria for epoch, cell, segment ...
(SDTM TESTRL, TEENRL)
• Timing Section (see further) enables to add:
– estimated duration (SDTM TEDUR)
Workflow
• workflow between activities
• visits (StudyEvent) can have several activities, e.g.:
– visit start activity (for scheduling)
– fill-a-form activity
– do-a-test activity
– give medication activity
• >90% of all clinical study workflows can be
described
Example Workflow (LZZT Study)
ODM-SDM Workflows can be
transformed
• There are many "standards" for describing
workflows, e.g.
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MS Workflow Foundation
BPEL
BPMN 2.0
XPDL ...
• ODM-SDM workflows can easily be transformed
into these, e.g. for use in Hospital Planning
Systems
The same workflow in BPMN 2.0
(automated transformation)
Timings
• Timings and timing windows can be defined
on:
– activities (e.g. "informed consent between
January 1 and February 28")
– transitions between activities (e.g. "activity 2 must
follow activity 1 within 24 hours with a time
window of -2 and +4 hours")
– activity durations (e.g. "activity is planned to be
take not more than 2 hours")
Conclusions
• ODM-SDM is a first step into a full machinereadable Protocol
• SDTM Trial Design datasets can be automatically
generated from ODM-SDM study designs
• ODM-SDM can contain much more detailed
information than the corresponding SDTM
datasets
• ODM-SDM is extremely helpfull for integration
with hospital information systems
• Design tools are already available, other vendors
will quickly follow
ODM-SDM can contain much more detailed
information of a study design than the
corresponding SDTM datasets
• If the FDA would like to be able to fully
reconstruct the design of a study ...
• They could better accept ODM-SDM instead of
Trial Design SDTM datasets