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Dorothy B. Dorotheo InterMune

CDISC Bay Area Users Group Meeting CDASH Status Update July 13, 2009. Dorothy B. Dorotheo InterMune. CDASH Status Update. CDASH Project Background and Overview CDASH-ODM: A “Starter Kit” of Machine-Readable Basic CRF Elements CDASH Version Updates & User Guideline status

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Dorothy B. Dorotheo InterMune

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  1. CDISC Bay Area Users Group MeetingCDASH Status UpdateJuly 13, 2009 Dorothy B. Dorotheo InterMune

  2. CDASH Status Update • CDASH Project Background and Overview • CDASH-ODM: A “Starter Kit” of Machine-Readable Basic CRF Elements • CDASH Version Updates & User Guideline status • CDASH Focus for 2009 2

  3. Project Snapshot • 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 October 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 3

  4. Participants Team 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 Participants in the CDASH Initiative Other = academic research organizations, government (NIH, NCI), hospitals, universities

  5. CDASH Purpose & 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. CDASH Development Steps • Started with regulatory electronic study submission standard - Study Data Tabulation Model (SDTM) • Focused on CRF Content, not CRF Layout • Collected > 150 CRF samples across industry • Evaluated commonalities/differences between CRF samples • Documented data points included/excluded with justifications

  7. CDASH Development Steps (Continued) Agreed on basic CRF collection fields Mapped to SDTM Defined required terminology with the CDISC Terminology Team Developed CRF question definitions and completion instructions for clinical sites and sponsors

  8. CDASH Version 1.0 Published October 2008 Available for download at: http://www.cdisc.org/standards/cdash/index.html

  9. How can CDASH be used today? • Use as a Content Standard • Off the shelf Case Report Form content • Describes relationship between Operational Data and Submission Datasets • CDASH represented several file format • Excel, Word, Proprietary EDC system format • Potentially unstructured • Use within Machine-Readable Metadata • CDASH represented in CDISC Operational Data Model (ODM) • Vendor neutral system with an independent format • Hierarchical structure is ideal for re-usable library of components

  10. Implementation to Date • Adopted by industry, eVendors and other organizations. • Utilized as a platform/template to support efforts around electronic health records (IHE & HITSPI efforts) • Harmonized with NCI’s caBIG project. (CDASH basic fields + Oncology fields = standard CRF in the oncology workspace) CDASH has and will continue to facilitate many positive changes on how clinical data can be collected. 10

  11. CDASH-ODM: A “Starter Kit” of Machine-Readable Basic CRF Elements

  12. CDASH-ODM Initiative: Started May 2008 • Participating Companies • InterMune, Formedix, Quintiles, Shire, Schwartz Pharma, Outcome, AstraZeneca, eLilly, Medidata, ERT, XClinical, IPL, Octagon Solutions, CDISC, Cerner, Greenway, PRA Intl., GSK, Forrest Laboratories, Genzyme - ODM/Core • Initial Scope: CDASH DOMAINS • AE, Prior & Concomitant Meds, Demography, Common Identifiers. • Initial Deliverables: March 2009 • Metadata tables • CRF representations • CRF with database annotations and CDASH alias • ODM files

  13. CDASH Delivers ContentNOT CRF Layout Basic data to be collected.. How to implement the CRF data collection variable Describes the purpose of the data collection field SDTM-IG based variable name(CDASH)(Variable name shaded) CRF Completion Instructions for Sites CDASH Core Designations

  14. A CDASH-ODM Form Contains:

  15. Optimal Solution from Standardized Content to any EDC System

  16. CDASH-ODM – AE Form in ODM 16

  17. CDASH-ODM – AE (Paper) 17

  18. CDASH-ODM – AE Form (EDC) 18

  19. CDASH-ODM – DM Form in ODM 19

  20. CDASH-ODM – DM (paper) 20

  21. CDASH-ODM – DM (EDC) 21

  22. CDASH-ODM – CM Form in ODM 22

  23. CDASH-ODM – CM FORM (Paper) 23

  24. CDASH-ODM – CM FORM (EDC) 24

  25. CDASH ODM

  26. CDASH Version Updates & User Guideline status

  27. CDASH Program Plan 2009-2010 ICVs Q409 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Released Q2 10 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Q4 09 Q2 10 CDISC Consensus Process

  28. CDASH Projects– Why are we doing this??? Eliminate some of the variety in CRFs Streamline training & support common understanding Reinforce collecting only key data Reduce collection of duplicate data - decreasing the potential for error Minimize data queries Facilitates populating CRFs by eHR without re-entry (Cuts down on study start time – for all stakeholders) Better quality of collected data Facilitates efficient mapping to SDTM for CDASH implementers 28

  29. Draft CDASH User (UG)

  30. CDASH USER GUIDE - TOC

  31. CDASH UG -- TOC

  32. CDASH UG -- TOC

  33. CDASH UG -- TOC

  34. CDASH UG -- TOC

  35. CDASH DEVICE Domains • 3 additional domains to be added to CDASH V 1.1 for DEVICES • SDTM & CDASH are being developed at the same time

  36. CDASH Focus for 2009

  37. Focus 2009 Develop CDASH Training Program Collect feedback from “Early Implementers” Update CDASH v. 1.0 to 1.1 Develop and Publish Machine Readable Metadata (CDASH ODM) Develop basic data collection fields for Devices Develop the CDASH-User Guide (CDASH-UG) Present, publish and train the CDASH standard at all appropriate venues

  38. Thanks to all the volunteers who have worked to get us where we are today! Comments and suggestions for improvement of the CDASH standard and CDASH ODM products are welcome. Contact: rfacile@cdisc.org

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