bay area cdisc implmentation network – july 13, 2009 how a new cdisc domain is made
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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. - PowerPoint PPT PresentationTRANSCRIPT
Bay Area CDISC Implmentation Network – July 13, 2009
How a New CDISC Domain is Made
Carey SmoakTeam 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
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
4
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
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