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Bay Area CDISC Implmentation Network – July 13, 2009 How a New CDISC Domain is Made

Bay Area CDISC Implmentation Network – July 13, 2009 How a New CDISC Domain is Made. Carey Smoak Team Leader CDISC SDTM Device Team. Overview. CDISC Snapshot New Domain Procedure Co-Development of CDASH and SDTM for New Domains Device Example Contact Information. CDISC Snapshot.

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Bay Area CDISC Implmentation Network – July 13, 2009 How a New CDISC Domain is Made

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  1. Bay Area CDISC Implmentation Network – July 13, 2009How a New CDISC Domain is Made Carey Smoak Team Leader CDISC SDTM Device Team

  2. Overview • CDISC Snapshot • New Domain Procedure • Co-Development of CDASH and SDTM for New Domains • Device Example • Contact Information

  3. CDISC Snapshot • Global, open, multi-disciplinary non-profit organization • Founded in 1997; incorporated in 2000 • Over 200 member organizations • Biopharmaceutical companies • Academic Research Institutes • Technology Vendors, etc… • Active Coordinating Committees • Europe • Japan • Additional activities • Australia • India • S. America and Africa • Established industry standards to support the electronic acquisition, exchange, submission and archiving of data to support regulated clinical research • Freely available on the CDISC website (www.cdisc.org) • Developed through open, consensus-based approach

  4. CDISC Standards Development Process Primary Stages

  5. New Domain Procedure • An Initial Consensus Version (ICV) of the new SDTM and CDASH domains are achieved & other specific fields/terminology for the 16 CDASH Domains. • Submit to CDISC Technical Leadership Committee and follow the Consensus Process.

  6. CDASH Component CDASH Project Snapshot • 16 Safety data domains developed • Consolidated document posted for public review in May 2008 • Received over 1800 comments from 46 companies, institutions and agencies. • All 3 ICH regions were represented in the public comment process • US • Europe • Japan • CDASH V1.0 published 2008 • Streamlines data collection at investigative sites - addresses Critical Path Opportunity #45 • Continuation of ACRO’s Initiative • Started October 2006 • Supported by a collaborative group of 17 organizations • Core team of 16 members manages.. • 11 working groups • Comprised of between 8-40 volunteers • ~190 working group volunteers

  7. CDASH Domains (N=16) • Common Identifier Variables • Common Timing Variables • Adverse Events (AE) • Concomitant Medications (CM) • Comments (CO) • Drug Accountability (DA) • Demographics (DM) • Disposition (DS) • Protocol Deviations (DV) • ECG (EG) • Exposure (EX) • Inclusion Exclusion (IE) • LAB Test Results (LB) • Medical History (MH) • Physical Exam (PE) • Vital Signs (VS) • Subject Characteristics (SC) • Substance Use (SU)

  8. DEVICE Example CDASH Development Steps • Review CDASH v 1.0 all domains • Co- develop with the SDTM Device Properties (DP) domain • Focused on CRF Content, not CRF Layout • Collected CRF samples – frequency analysis • Evaluated commonalities/differences between CRF samples • Documented data points included/excluded with justifications

  9. DEVICE Example CDASH Development Steps (2) • Agree on basic device CRF collection fields  • Assign Core Designation (Highly recommended, etc.) • Map to draft SDTM DP domain • Define required terminology – forward to Terminology team. • Develop CRF question definitions and completion instructions for clinical sites and sponsors • Incorporate DP domain into CDASH V 1.1

  10. CDASH Program Plan 2009-2010 ICVs Q409 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Released Q2 10 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Q4 09 Q2 10 CDISC Consensus Process

  11. Contact • Carey Smoak • Team Leader • Roche Molecular Systems, Inc. • E-mail: carey.smoak@roche.com

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