1. CDM SIAC All Hands Call Rhonda Facile Director, CDASH Project CDISC
CDISC Webinar Series: From Collection to Submission – Efficiently Mapping between CDASH and SDTM
CDISC Webinar Series: From Collection to Submission – Efficiently Mapping between CDASH and SDTM
CDM SIAC All Hands Call
Thursday, November 19, :00 AM EST
Part 2- Mapping from CDASH to
Submission (SDTM) Data Sets
3 September 2009
Part 2- Mapping from CDASH to
Submission (SDTM) Data Sets
3 September 2009
Rhonda Facile
Gary Walker
Director, CDASH Project, CDISC
Quintiles Transnational Corp.
Associate Director, Enterprise Data Standards
Shannon Labout
Consultant
Lauren Shinnaberry
Senior Project Manager, PRA International
Rhonda Facile
Director, CDASH Project
CDISC
Rhonda Facile
Director, CDASH Project, CDISC
Gary Walker
Associate Director, Enterprise Data Standards
Quintiles Transnational Corp.
Shannon Labout
Consultant
Lauren Shinaberry
Senior Project Manager, PRA International 1

2. 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 (
Developed through open, consensus-based approach 2

3. Project Snapshot
Critical Path Opportunity #45 - Streamlines data collection at investigative sites
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
18 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 October 2008 3 3

4. Critical Path Opportunity Projects Initiated During 2006
Streamlining Clinical Trial Data Collection
Opportunity #45
Private efforts to streamline clinical trial data collection through voluntary standardization of case report forms (CRFs) have recently been formalized under the auspices of the Clinical Data Acquisition Standards Harmonization (CDASH) Initiative. Catalyzed by the Clinical Data Interchange Standards Consortium and the Association of Contract Research Organizations, dozens of product sponsors, investigators, data managers and other stakeholders are working together to agree on a core set of data collection fields to support clinical research studies (i.e., creation of consensus CRFs and implementation guides for four "safety data/domains": adverse events, prior medications, concomitant medications, demographics and subject characteristics). FDA is providing input on issues as requested (e.g., FDA requirements). The CDASH process is open to any participant and will include a public comment process (see ).

5. Collaborative Group Members
American Medical Informatics Association (AMIA)
Association of Clinical Research Organizations (ACRO)
Association of Clinical Research Professionals (ACRP)
Baylor College of Medicine
Biotechnology Industry Organization (BIO)
Clinical Data Interchange Standards Consortium (CDISC)
Clinical Research Forum
Critical Path Institute
Duke Clinical Research Institute (DCRI)
Food and Drug Administration (FDA)
NIH - NCI - caBIG
NIH - Clinical Research Policy Analysis & Coordination Program
National Clinical Research Resources (NCRR)
NIH - National Institute of Child Health & Human Development (NICHD)
National Library of Medicine (NLM)
Pharmaceutical Research and Manufacturers Association (PhRMA)
Society for Clinical Data Management (SCDM) 5

6. CDASH Project Scope
Develop content standards for a basic set of global industry-wide CRF fields to support clinical research
element name
definition
metadata
Initial scope limited to most commonly collected data
These CRF standards apply across all therapeutic areas and phases of clinical development (I-IV)
Follow CDISC defined standards development process. 6

7. Practical Benefits Eliminate some of the variety in CRFs
Supports common understand
Enables better quality data collection
Reinforces collecting only key data
Reduces collection of duplicate data - decreasing the potential for error
Minimizes data queries
Shortens study start time
Facilitates the population of CRFs via an eHR (without re-entry)
Allows implementers to map efficiently to SDTM 7 7

8. 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 Focused Group and Open Public; Harmonization and Testing throughout; V1.0 Release
Stage III: Education & Support
Stage IV: Standards Update & Maintenance

9. 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) 9

10. CDASH Domain Tables How to
BRIDG Mappings
Question Text & Prompts to V 1.1 1 2 3 4 5 6
Data Collection Field
Variable Name (CDASH variable name shaded)
Definition
Case Report Form Completion Instructions
Additional Information for Sponsors
CDASH Core
Basic data to be collected
How to
implement
the CRF
data collection variable
Describes the purpose of the data collection field
Can be either a topic description or the Question text.
SDTM-IG based variable name (CDASH) (Variable name shaded)
CRF
Completion Instructions
for Sites
CDASH Core Designations

11. Key Collaborations CDISC cross-team collaboration
SDS Team - SDTM
Controlled Terminology Team
BRIDG Team
Collaboration with NIH-NCI-caBIG project
Standardized cancer-specific CRF fields + CDASH basic data collection fields (safety+efficacy data!)
Healthcare – CDASH Link
allows electronic patient data to flow directly from the eHR into CDASH CRFs

12. Caveat – work done by volunteers, many dependencies!
Next Steps
Update CDASH v. 1.0 (v.1.1)
CDASH-User Guide (CDASH-UG)
Machine Readable Metadata (CDASH-ODM)
AdvaMed-CDISC Device Project
Target Q110 – early Q210
Caveat – work done by volunteers, many dependencies!

13. CDASH Core Team Members
Rhonda Facile
Gary Walker
Dorothy Dorotheo
Paul Bukowiec
Trisha Simpson
Shannon Labout
Liz Nulton-Bodiford
Jay Leeka
Alec Vardy
Kim Truett
Kit Howard
Lorna Griffin
Lauren Shinnaberry
Melissa Binz

14. CDASH Core Team Members
Charlene Dark
Jennifer Price
Chandra Wooten
Jerry Salyers
Matt Leary
Dawn Kaminski
Dan Crawford
Kathryn Hanson
Casey Higgins
Melissa Cook
David Borbas
Grace Kao
Joris DeBondt
Kesi Sanders

15. CDASH Core Team Members
Martha Schmidt
Priya Gopal
Quyen Nuyen
Young Kim
Rachel Richardsson
Brooke Hinkson
Valeria Paxton
Cynthia Baxter
+ Domain Team Members……

16. Questions??

17. Strength through collaboration.