CDASH Initiative

Rhonda FacileProject Director, CDISC

CDASH Project UpdateAtlantic User Group21 February 2008

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CDISC Snapshot• Global, open, multi-disciplinary non-profit organization

– Founded in 1997; incorporated in 2000– Nearly 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

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Agenda• History • Charter• Collaborative Group• Key Collaborations• COP-001• Project Organization• Work Stream Procedures• Current Status• Focus 2008 • Core Team Contact• Thanks!

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History

• Critical Path Initiative #45; Build on work started by ACRO

• Jan 2006 - CDISC requested to take leadership role as established standards development organization during the DIA Open Forum “Creating Clinical Trial Efficiencies Through Standard Data Collection”.

• June 2006 – Initial Collaborative Group (10) announced by Dr. Woodcock at Annual DIA Meeting in Philadelphia “Human Subject Protection/Bioresearch Monitoring Initiative and Critical Path Update”

• October 2006 – Collaborative Project Kickoff, Cary N.C.

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Charter• To develop a set of ‘content standards’ (element name,

definition, metadata) for a basic set of global industry-wide data collection fields that support clinical research.

• The initial scope - ‘safety data/domains’.

• These safety domains cut across all therapeutic areas.

• Follow CDISC Operating Procedure for Standards Development (COP-001).

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Collaborative Group - Role

• provides expertise and strategic input to the CDASH Project Team.

• contributes and/or helps identify resources as needed to enable achievement of the mission, goals and deliverables.

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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)

• National Institutes of Health (NIH)– NCI-EVS – NCI-caBIG – Clinical Research Policy Analysis &

Coordination Program– National Clinical Research Resources

(NCRR)– National Institute of Child Health &

Human Development (NICHD) • Pharmaceutical Research and

Manufacturers Association (PhRMA)

• Society for Clinical Data Management (SCDM)

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Key Collaborations• NIH

– NCI-EVS – NCI-caBIG – Clinical Research Policy Analysis & Coordination Program– National Clinical Research Resources (NCRR)– National Institute of Child Health & Human Development

(NICHD)

• CDISC SDS Team• CDISC Terminology Team• Healthcare Link

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CDASH – SDS TeamFDA - Proposed Rule

• require (not just accept) electronic submissions

• require submissions to be in the SDTM format

• proposed 2 year implementation (proposed rule not yet written)

Federal Register / Volume 71, No. 237 /Monday, December 11, 2006

So…CDASH collection variables must map into the SDTM.

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CDASH - Terminology

CDASH: aligning SDTM terminology projects with CDASH requirements…full harmonization planned for Q1 2008

CDASH = QuestionsTerminology = Answers

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CDASH - IHEIntegrating the Healthcare Enterprise (IHE)

• Electronic Health Records (EHR)

• Using CDASH Data Collection Variables to creating a profile, that can be used to populate a basic eCRF.

• Facilitate Single Source data entry.

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CDISC Standards Development Process (COP-001) Primary Stages

Stage I: Standard Definition/ApprovalMultidisciplinary Team Initiation; Working Plan Development

Stage III: Education & Support

Stage IV: Standards Update & Maintenance

Stage II: Standards Development-Consensus Model; Reviews by External Focused Group and Open Public; Harmonization and Testing throughout; V1.0 Release

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Organization

Stream Members

Core Team

CDISC Technical Advisory Committee

CDASH Collaborative Group

•11 CDASH Streams (sub-groups)•~190 volunteers

CDISC Technical Leadership Committee

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Organization

Stream membership:

•Statisticians•Medical Monitors/Clinical Scientists•Regulatory Affairs•Drug Safety•Data Managers•Clinical Study Coordinators•Clinical Research Associates•Investigators•Clinical Program Managers•Statistical Programmers•Database programmers

Need more multi-national input!

CROs42%

Pharma32%

Biotech8%

Other18%

Participants in the CDASH Initiative

Other = Academic Research Organizations, Government (NIH, NCI), Hospitals, Universities, Military.

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Process• Start with Study Data Tabulated Model (SDTM)

• Initial Focus on CRF Content, not CRF Layout

• Refer to ACRO CRF Samples (where available)

• Collect CRF samples

• Evaluate commonalities/differences of CRF samples

• Document data points included/excluded with justifications

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Deliverables

• Agree on basic data collection fields

• Map to SDTM

• Terminology - proposals Terminology Team

• Write definitions and completion instructions for clinical site and Sponsors

• Proceed to the next step in the Consensus Process

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StatusPackage-1: Adverse Events (AE)

Concomitant Medication (CM)Demographics (DM)Subject Characteristics (SC)

• Started October 2006 • TLC and Collaborative Group (CG) reviews - completed• CG comments are now being addressed and a “Reviewed Version”

achieved

Consensus (Initial)Version

Harmon-ized

Version

Released(Production)Version

1.0

ReviewVersionTLC

Review OK Collaborative

GroupReview

OK

PublicReview

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StatusPackage-2: Inclusion/Exclusion Criteria (IE)

Medical History (MH)Substance Use (SU)Physical Exam (PE)Vital Signs (VS)

• Started December 2006 • TLC and Collaborative Group (CG) reviews are completed• CG comments being addressed, “Reviewed Version” created

OK

Consensus (Initial)Version

Harmon-ized

Version

Released(Production)Version

1.0

ReviewVersionTLC

Review Collaborative

GroupReview

OK

PublicReview

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StatusPackage-3: Drug Accountability (DA)

Exposure (EX)Comments (CO)Deviations (DV)Disposition (DS)

• Started March 2007• TLC and Collaborative Group review complete• CG comments being addressed and a “Reviewed Version” created

OK

Consensus (Initial)Version

Harmon-ized

Version

Released(Production)Version

1.0

ReviewVersionTLC

Review Collaborative

GroupReview

OK

PublicReview

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Status

Package-4: Lab (LB)ECG (EG)

• Started July 2007 • TLC review completed• CG review ongoing – comments due 22 Feb.

Consensus (Initial)Version

Harmon-ized

Version

Released(Production)Version

1.0

ReviewVersionTLC

Review Collaborative

GroupReview

OK

PublicReview

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Status – February 2008

16 DOMAINS

Initial Consensus

Version (ICV)

TLC Review Period

Harmonized Version

(HV)

Collaborative Group Review Period

Reviewed Version

(RV)

Public Review To Start End of

Released Version

1.0 End of

Adverse Events (AE) Dec 06 Mar 07 May07 Jul 07 Nov 07 Q108 Q208

Concomitant Medication (CM) Jan 07 Apr 07 May 07 Jul 07 Nov 07 Q108 Q208

Demographics (DM) Subject Characteristics (SC) Jan 07 Apr 07 May 07 Jul 07 Nov 07 Q108 Q208

Inclusion/Exclusion Criteria (IE) Feb07 May 07 Aug 07 Oct 07 Nov 07 Q108 Q208

Medical History (MH) Substance Use (SU) Feb 07 May 07 Aug 07 Oct 07 Nov 07 Q108 Q208

Physical Exam (PE) Vital Signs (VS) Feb 07 May 07 Aug 07 Oct 07 Nov 07 Q108 Q208

Disposition (DS) Jun 07 Aug 07 Nov 07 Dec 07 Feb 08 Q108 Q208

Drug Accountability (DA) Exposure (EX) Jun 07 Aug 07 Nov 07 Dec 07 Feb 08 Q108 Q208

Protocol Deviations (DV) Comments (CO) Jun 07 Aug 07 Nov 07 Dec 07 Feb 08 Q108 Q208

Lab (LB) Oct 07 Nov 07 Dec 07 Feb 08 Mar 08 Q108 Q208

ECG (EG) Nov 07 Nov 07 Dec 07 Feb 08 Mar 08 Q108 Q208

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CDASH Deliverable – per domain

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Focus – 2008 Demo – Using CDASH Variables

1. CDASH Standard Forms

2. CDISC SDTM Standard

3. CDASH Forms + SDTM Standard = Annotated Form

5. Standard electronicmetadata

configures collection system

4. Annotated Form + ODM Standard = Standard electronicmetadata (XML)

<ODM> <Study> <Meta… </Meta… </Study></ODM>

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Focus 2008 & OnwardCDISC Supported Activities• Refine and post CDASH final draft for public review• Refine and post CDASH V. 1.0 on CDISC.org.• Development & implement CDASH training program.• Present the CDASH standards at conferences, webinars

and user group meetings.• Collect feedback from “Early Implementers” and update

CDASH v. 1.0 as required (follow Stage IV of COP-001)• “CDASH” New Domains as they emerge.Future Activities?• Standardize basic therapeutic area data variables

(cooperate with other ongoing initiatives)• Devices, Imaging…perhaps

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CDASH Project ProcessCDASH Core Team Contact Information• Rhonda Facile rfacile@cdisc.org• Gary Walker gary.walker@quintiles.com• Dorothy Dorotheo DDorotheo@intermune.com• David E. Tatum tatum4@comcast.net• Paul Bukowiec Paul.Bukowiec@mpi.com• Trisha Simpson Trisha.Simpson@UCB-roup.com • Shannon Labout slabout@csscomp.com• Liz Nulton-Bodiford liz.m.nulton-bodiford@gsk.com• Jay Leeka Jay.Leeka@astrazeneca.com• Alec Vardy a.vardy@comcast.net• Kim Truett Kim.Truett@kctdm.com• Holly Peterson Holly.Peterson@frx.com• Kit Howard kit@kestrelconsultants.com

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We have come along way…..but there is much left to be done

Thanks to all the volunteers who have worked to get us where we are today!

Please Review the CDASH Draft when posted in early April 2008!

Visit cdisc.org often to keep informed or contact rfacile@cdisc.org.

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Strength through collaboration.