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

2. 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)www.cdisc.org –Developed through open, consensus-based approach

4. CDISC Standards Development Process Primary Stages Stage IV: Standards Update & Maintenance Stage III: Education & Support Stage II: Standards Development-Consensus Model; Reviews by External Focused Group and Open Public; Harmonization and Testing throughout; V1.0 Release Stage I: Standard Definition/Approval : Multidisciplinary Team Initiation; Working Plan Development 4

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. 5 Initial Consensus Version (ICV) TLC Review Harmonized Version (HV) External Focused Review Reviewed Version (RV) Public Review Released (Production) Version 1.0

6. CDASH Component 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 CDASH Project Snapshot

7. CDASH Domains 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) (N=16)

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- ODM Set-1 ODM & CRFs Set-2 ODM & CRFs Set-3 ODM & CRFs CDASH User Guide V 1.0 CDASH ODM CRFs CDASH DEVICE Properties Accountability Malfunction Initial Consensus Version (ICV) TLC Review Harmonized Version (HV) External Focused Review Reviewed Version (RV) Public Review Released (Production) Version 1.0 CDASH Program Plan 2009-2010 CDASH V 1.1 Correction /Additions Device domains CDASH- ODM ICVs Q409 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 ICVs Q409 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 CDISC CONSENSUS PROCESS Q2 10 Q4 09 Released Q2 10 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Released Q2 10 CDASH-ODM CDASH V 1.1 CDASHUG 1.0

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