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CDASH Initiative

CDASH Initiative. CDASH Project Update Atlantic User Group 21 February 2008. Rhonda Facile Project Director, CDISC. CDISC Snapshot. Global, open, multi-disciplinary non-profit organization Founded in 1997; incorporated in 2000 Nearly 200 member organizations Biopharmaceutical companies

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CDASH Initiative

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  1. CDASH Initiative CDASH Project Update Atlantic User Group 21 February 2008 Rhonda Facile Project Director, CDISC

  2. 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

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

  4. 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.

  5. 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).

  6. 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.

  7. 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) Collaborative Group Members

  8. 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

  9. FDA - 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) CDASH – SDS Team Federal Register / Volume 71, No. 237 /Monday, December 11, 2006 So…CDASH collection variables must map into the SDTM.

  10. CDASH - Terminology CDASH: aligning SDTM terminology projects with CDASH requirements…full harmonization planned for Q1 2008 CDASH = Questions Terminology = Answers

  11. CDASH - IHE Integrating 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.

  12. CDISC Standards Development Process (COP-001) 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

  13. Organization CDISC Technical Advisory Committee CDASH Collaborative Group CDISC Technical Leadership Committee Core Team Stream Members • 11 CDASH Streams (sub-groups) • ~190 volunteers

  14. 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! Participants in the CDASH Initiative Other = Academic Research Organizations, Government (NIH, NCI), Hospitals, Universities, Military.

  15. 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

  16. 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

  17. Status Package-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 Review Version Released (Production) Version 1.0 OK Public Review TLC Review Collaborative Group Review OK

  18. Status Package-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 Consensus (Initial) Version Harmon- ized Version Review Version Released (Production) Version 1.0 OK Public Review TLC Review Collaborative Group Review OK

  19. Consensus (Initial) Version Harmon- ized Version Review Version Released (Production) Version 1.0 OK Public Review TLC Review Collaborative Group Review Status Package-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

  20. Consensus (Initial) Version Harmon- ized Version Review Version Released (Production) Version 1.0 OK Public Review TLC Review Collaborative Group Review Status Package-4: Lab (LB) ECG (EG) • Started July 2007 • TLC review completed • CG review ongoing – comments due 22 Feb.

  21. Status – February 2008

  22. CDASH Deliverable – per domain

  23. Focus – 2008 Demo – Using CDASH Variables 1. CDASH Standard Forms 4.Annotated Form + ODM Standard = Standard electronic metadata (XML) <ODM> <Study> <Meta… </Meta… </Study> </ODM> 5.Standard electronic metadata configures collection system 3. CDASH Forms + SDTM Standard = Annotated Form 2.CDISC SDTM Standard

  24. Focus 2008 & Onward CDISC 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

  25. CDASH Project Process CDASH 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

  26. 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.

  27. Strength through collaboration. 27

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