CDASH Initiative. Dorothy Dorotheo Director, Clinical Data Management Intermune, Inc. Rhonda Facile Director CDASH Project, CDISC

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1 CDASH Initiative CDASH Project Update 6 December 2007 Bay Area User Group Dorothy Dorotheo Director, Clinical Data Management Intermune, Inc. Rhonda Facile Director CDASH Project, CDISC

CDISC Snapshot Global, open, multi-disciplinary non-profit organization Founded in 1997; incorporated in 2000 Nearly 200 member organizations Biopharmaceutical companies Academic Research Institutes

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 ( Developed through open, consensus-based approach 2

3 Clinical Data Acquistion Standards Harmonization Outline Background, Charter and the Collaborative Group (RF) CDISC COP 001 (RF) Project Organization (RF) Project Process (DD) Project Status (DD) SDTM and Terminology (DD) Practical Experience (DD) Next Steps (RF) Core Team Contact Info (RF) 3

4 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 4

5 Background Critical Path Initiative #45; Build on work started by ACRO Jan DIA Open Forum Creating Clinical Trial Efficiencies Through Standard Data Collection organized by CDISC, FDA, ACRO CDISC requested to take leadership role as established standards development organization 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

6 CDASH Project Charter CDASH = Clinical Data Acquisition Standards Harmonization Project 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 will be the safety data/domains. These safety domains cut across all therapeutic areas, beginning with approximately domains. Follow CDISC Operating Procedure for Standards Development (COP-001). 6

7 Collaborative Group Role: To participate in the Collaborative Group Steering Committee, that provides expertise and strategic input to the CDASH Project Team and Streams. To contribute and/or help identify resources as deemed necessary to enable achievement of the mission, goals and deliverables for this project. 7

8 Collaborative Group: Provides expertise and strategic input into the CDASH Initiative 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) 8

9 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 9

10 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 10

11 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; s by External Focused Group and Open Public; Harmonization and Testing throughout; V1.0 Release Stage III: Education & Support Stage IV: Standards Update & Maintenance 11

12 Standards Development Process for CDISC (COP-001) Stage I: Standard Definition/Team Initiation Need for Specific Standard(s) Identified (any stakeholder) Proposal to Board of Directors (via OIS) per strategy, budget priorities Approved Team Leader ID And Team Formation (multidisciplinary) (OIS) Current Status Working Plan (timelines, deliverables communication mech., resources req d) (Team ) Not Approved Stage II: Standards Development//V 1.0 Release Consensus (Initial) TLC Harmonized OK Testing Comments addressed Ex Focused OK Public Released (Production) 1.0 Comments to address by team Stage III: Education & Support Respond To Comments And Questions Educational Programs (EDU, OIS) Stage IV: Standards Update & Maintenance Annual of Released (comments, chg reqsts, tests, plans) (Team) Working Plan (timelines, deliverables, communication mech., resources req d) (Team) Consensus (Revised) Optional SPCC Ex Focused Harmonized Public as needed Note: Occasional bug fix releases may be issued as needed with team review only. New Released (Production) 12

13 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 13

14 CDASH Collaborative Group CDISC Technical Advisory Committee CDISC Technical Leadership Committee Core Team Stream Members 9 CDASH Streams (sub-groups) Comprised of ~190 volunteers 14

15 Project 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 e Vendors Need more multi-national input! Participants in the CDASH Initiative Biotech 8% Other 18% Pharma 32% CROs 42% Other = Academic Research Organizations, Government (NIH, NCI), Hospitals, Universities. 15

16 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 16

17 Process *Guiding principles: variables should Address either directly or indirectly SDTM required elements Be standard but flexible to allow customization within defined limits Limit variables to required and necessary Comply with regulatory requirements Reduce redundancies Increase collection of meaningful data Facilitate use of standards by all users Be appropriate for use both pre and post approval studies Allow consistent and efficient data collection/storage/transmission and analysis * ACRO s development principles, CDASH Kick-off Meeting, October 2006, Cary, N.C. 17

18 CDASH: Getting Started Start with Study Data Tabulated Model (SDTM) Data Variable Tables Refer to ACRO CRF Samples (where available) Initial Focus on CRF Content, not CRF Layout Collect CRF samples Evaluate commonalities/differences of CRF samples and SDTM Document data points included/excluded with justifications 18

19 Process Deliverables Reach agreement on basic CRF Data collection variables Map to SDTM - in cooperation with the SDTM development team Terminology Provide Terminology proposals to the Terminology team Add definitions Write completion guidelines/instructions Proceed to the next step in the Consensus Process as specified in COP- 001 Technical Leadership Committee (TLC) 19

20 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 20

21 CDASH Package-1: Adverse Events, Concomitant Medication, Demographics & Subject Characteristics Oct launch at Project Kick-off meeting TLC and Collaborative Group (CG) reviews are completed CG comments are now being addressed and a ed achieved Consensus (Initial) TLC Harmonized OK Collaborative Group O K Public Released (Production)

22 Basic Data Collection Fields Identified: AE Adverse Event Term (*AETERM) Start Date (*AESTDTC) Stop Date (*AEENDTC) Seriousness (*AESER) Relationship (*AEREL) Action Taken (*AEACN) Outcome (*AEOUT) AE Severity (*AESEV) or AE Toxicity (*AETOXGR) CM Reported name of Drug, Medication or Therapy (*CMTRT) Start Date (*CMSTDTC) Stop Date (*CMENDTC) DM DM & SC Year Year of Birth of (*BRTHDTC) Birth (*BRTHDTC) Month Month of Birth of (*BRTHDTC) Birth (*BRTHDTC) Sex (*SEX) Sex (*SEX) Race Race of Subject of Subject (*RACE) (*RACE) Year of Birth (*BRTHDTC) Month of Birth (*BRTHDTC) Sex (*SEX) Race of Subject (*RACE) Optional data collection variables have also been identified. * Variable names are from the SDTM. 22

23 CDASH Package-2: Inclusion/Exclusion Criteria, Medical History & Substance Use, Physical Exam & Vital Signs Dec launch TLC and Collaborative Group (CG) reviews are completed CG comments are now being addressed and a ed achieved Consensus (Initial) TLC Harmonized OK Collaborative Group O K Public Released (Production)

24 CDASH Package-3: Drug Accountability & Exposure, Comments & Deviations, Disposition/End of Study Mar launch TLC review complete Collaborative Group review start December 5. Consensus (Initial) TLC Harmonized OK Collaborative Group O K Public Released (Production)

25 CDASH Package-4: Lab & ECG July 2007 Launch Lab ICV delivered now under TLC review ECG ICV due ASAP CG review planned for December 2007 Consensus (Initial) TLC Harmonized Collaborative Group O K Public Released (Production)

26 Initial Consensus TLC Harmonized Collaborative Group ed Public Released 1.0 Adverse Events Dec March 2007 May 2007 June-July 2007 Nov 2007 Q108 Q Prior & Concomitant Medication Jan 2007 April 2007 May 2007 June July 2007 Nov 2007 Q108 Q Demographics & Subject Characteristics Jan April 2007 May 2007 June July 2007 Nov 2007 Q108 Q Inclusion/Exclusion Criteria February 2007 May 2007 August 2007 Oct 2007 Oct-Nov 2007 Q108 Q Medical History and Substance Use February 2007 May 2007 August 2007 Oct 2007 Oct-Nov 2007 Q108 Q Physical Exam & Vital Signs February 2007 May 2007 August 2007 Oct 2007 Oct-Nov 2007 Q108 Q End of Study/ Disposition June 2007 Aug 2007 Nov 2007 Nov-Dec 2007 ongoing Dec 2007 Q108 Q Drug Accountability/ Exposure June 2007 Aug 2007 Nov 2007 Nov-Dec 2007 ongoing Dec 2007 Q108 Q Protocol Deviations/ Comments June 2007 Aug 2007 Nov 2007 Nov-Dec 2007 ongoing Dec 2007 Q108 Q Lab Oct Nov ongoing December 2007 Jan Feb Q108 Q ECG Nov Nov December 2007 Jan Feb Q108 Q

27 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 27

28 FDA - Proposed Rule Federal Register / Volume 71, No. 237 / Monday, December 11, 2006 require (not just accept) electronic submissions require submissions to be in the SDTM format proposed 2 year implementation (actual proposed rule not yet written) 28

29 AE Relatedness Example AE Relatedness to Study Drug (CDISC AEREL, no standard codelist defined) Company 1 No Unlikely Possible Probably Definite Company 2 Not Related Doubtful Possible Very Likely Probable Company 3 NO YES / Unknown 29

30 SDTM Terminology Projects SDTM Package-1: 30 code lists & more than 700 controlled terms - Now in production Labtest: single code list with 92 controlled terms - Now in production 200 additional Analyte terms in development and available for public review Q SDTM Package-2A: 12 code lists & more than 600 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units of Measure completed Public SDTM Package-2B: 17 code lists & 500+ controlled terms for AE, Physical Exam, Vital Signs and Subject Chars, including Anatomical Location in development 30

31 Harmonization Activities CDASH: aligning SDTM terminology projects with CDASH requirements full harmonization planned for Q CDASH = Questions Terminology = Answers 31

32 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience (DEMO) Next Steps Core Team Contact Info 32

33 1. ACRO Standard Form Practical Experience & Goal 4. Annotated Form + ODM Standard = Standard electronic metadata (XML) <ODM> <Study> <Meta </Meta </Study> </ODM> 3. ACRO Form + SDTM Standard = Annotated Form 5. Standard electronic metadata configures collection system 2. CDISC SDTM Standard 33

34 ACRO Adverse Event Form 34

35 Annotated 35

36 Electronic Configuration Courtesy of Assero 36

37 Electronic Configuration Courtesy of Formedix 37

38 Courtesy of XClinical 38

39 Courtesy of Outcome 39

40 Integrating the Healthcare Enterprise (IHE) Patient Care Coordinating Committee (PCCC) Electronic Health Records (EHR) Facilitate Single Source data entry. CDASH data collection elements to be used to create a profile, that can be used to populate a basic ecrf. 40

41 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status SDTM and Terminology Practical Experience Next Steps Core Team Contact Info 41

42 CDASH Project Standardize basic therapeutic area data variables (cooperate with other ongoing initiatives) Devices Imaging CDISC Supported Activities New Domains to be CDASHed Periodic update/revision of CDASH developed domains and documentation (Stage IV of COP-001) Training 42

43 Background, Charter and the Collaborative Group CDISC COP 001 Project Organization Project Process Project Status Practical Experience SDTM and Terminology Next Steps Core Team Contact Info 43

44 CDASH Project Process CDASH Core Team Contact Information Rhonda Facile Gary Walker Dorothy Dorotheo David E. Tatum Paul Bukowiec Trisha Simpson Shannon Labout Liz Nulton-Bodiford Jay Leeka Alec Vardy Kim Truett 44

45 CDASH Project Process Thanks to all the volunteers who have worked to get us where we are today. GET INVOLVED! contact Bron Kisler (Terminology): 45

46 Knowing is not enough; we must apply Willing is not enough; we must do Goethe 46

CDASH Clinical Data Acquisition Standards Harmonization

CDISC Italian User Group Meeting 16 November 2007 CDASH Clinical Data Acquisition Standards Harmonization 1 Outline Background Organization Goals Timelinesand Process Review of progress Results Future