From ODM-SDM to SDTM

Prepared by Jozef Aerts - XML4PharmaPresented 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)– 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

• 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.– 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 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

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