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From ODM-SDM to SDTM

From ODM-SDM to SDTM. Prepared by Jozef Aerts - XML4Pharma Presented by Kurt Hellstern, Hands-on GmbH. 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)

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From ODM-SDM to SDTM

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  1. From ODM-SDM to SDTM Prepared by Jozef Aerts - XML4Pharma Presented by Kurt Hellstern, Hands-on GmbH

  2. 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 => XML !

  3. Elements in ODM and ODM-SDM • In ODM: <StudyEventDef …. …> ….. </ StudyEventDef > • In ODM-SDM: <sdm:Summary> …. </sdm:Summary>

  4. Study Parameters Maps 1:1 to SDTM Domain TS (Trial Summary)

  5. Eligibility Criteria

  6. 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)

  7. Study Structure • Arms • Epochs • Cells • Segments • Activities (new)

  8. Study Structure in ODM Study Designer tool

  9. 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)

  10. 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

  11. Example Workflow (LZZT Study)

  12. 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

  13. The same workflow in BPMN 2.0(automated transformation)

  14. 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")

  15. 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

  16. 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

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