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

Bay Area CDISC Implmentation Network – July 13, 2009

How a New CDISC Domain is Made

Carey SmoakTeam Leader

CDISC SDTM Device Team

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Overview• CDISC Snapshot

• New Domain Procedure

• Co-Development of CDASH and SDTM for New Domains

• Device Example

• Contact Information

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

CDISC Standards Development Process Primary Stages

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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.

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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

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)

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

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

CDASH Program Plan 2009-2010

ICVs Q409CDASH-ODMCDASH V 1.1

CDASHUG 1.0

ICVs Q409CDASH-ODMCDASH V 1.1

CDASHUG 1.0

CDISC CONSENSUS PROCESSQ210

Q409

ReleasedQ2 10

CDASH-ODMCDASH V 1.1CDASHUG 1.0

ReleasedQ2 10

CDASH-ODMCDASH V 1.1CDASHUG 1.0

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Contact• Carey Smoak

– Team Leader

– Roche Molecular Systems, Inc.

– E-mail: [email protected]