Transcript Slide 1

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
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CDISC Snapshot
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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
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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
Stage I: Standard Definition/Approval : Multidisciplinary Team Initiation; Working
Plan Development
Stage II: Standards Development-Consensus Model; Reviews by External Focused
Group and Open Public; Harmonization and Testing throughout; V1.0 Release
Stage III: Education & Support
Stage IV: Standards Update & Maintenance
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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.
Initial
Consensus
Version (ICV)
TLC Review
Harmonized
Version (HV)
External
Focused
Review
Reviewed
Version (RV)
Public
Review
Released
(Production)
Version 1.0
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CDASH Component
CDASH Project Snapshot
• 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
• 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
CDASH Domains
(N=16)
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Common Identifier Variables
Common Timing Variables
Adverse Events (AE)
Concomitant Medications
(CM)
Comments (CO)
Drug Accountability (DA)
Demographics (DM)
Disposition (DS)
Protocol Deviations (DV)
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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)
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)
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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
CDASHODM
CDASH
DEVICE
Set-1
ODM &
CRFs
Set-2
ODM &
CRFs
Set-3
ODM &
CRFs
Properties
Accountability
Malfunction
CDASH
V 1.1
Correction
/Additions
CDASH
CDASH
ODM
CRFs
User Guide
V 1.0
Q4
09
Device
domains
ICVs Q409
CDASH-ODM
CDASH V 1.1
CDASHUG
1.0
Released
Q2 10
CDASHODM
CDASH-ODM
CDASH V 1.1
CDASHUG 1.0
Q2
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CDISC CONSENSUS PROCESS
Initial
Consensus
Version (ICV)
TLC Review
Harmonized
Version (HV)
External
Focused
Review
Reviewed
Version (RV)
Public
Review
Released
(Production)
Version 1.0
Contact
• Carey Smoak
– Team Leader
– Roche Molecular Systems, Inc.
– E-mail: [email protected]
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