From ODM-SDM to SDTM

1
From ODM-SDM to SDTM

• Prepared by Jozef Aerts - XML4Pharma
• Presented by Kurt Hellstern, Hands-on GmbH

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The ODM-SDM Extension

• 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 gt XML !

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Elements in ODM and ODM-SDM

• In ODM
• ltStudyEventDef . gt
• ..
• lt/ StudyEventDef gt
• In ODM-SDM
• ltsdmSummarygt
• .
• lt/sdmSummarygt

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Study Parameters
Maps 11 to SDTM Domain TS (Trial Summary)
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Eligibility Criteria
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Eligibility Criteria

• list of inclusion and exclusion criteria
• criterium itself (ConditionDef)
• human-readable (Description)
• machine-readable (FormalExpression)
• 11 mapping to SDTM domain TI (Trial
  Inclusion/exclusion Criteria)

7
Study Structure

• Arms
• Epochs
• Cells
• Segments
• Activities (new)

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Study Structure in ODM Study Designer tool
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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)

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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
• gt90 of all clinical study workflows can be
  described

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Example Workflow (LZZT Study)
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ODM-SDM Workflows can be transformed

• There are many "standards" for describing
  workflows, e.g.
• 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

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The same workflow in BPMN 2.0(automated
transformation)
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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")

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Conclusions

• ODM-SDM is a first step into a full
  machine-readable 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

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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