Introduction to CDASH

Transcription

1 Introduction to CDASH Rhonda Facile, CDISC Melissa Binz, Wyeth Presented by Melissa Binz Director Central Standards Group, Wyeth 1

2 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Survey of Domains Practical Implementation Wrap-up and Q & A 2

3 Clinical Data Acquisition Standards Harmonization Yes, it was a stretch but it made a fine acronym!! 3

4 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Survey of Domains Practical Implementation Wrap-up and Q & A 4

5 History Current state - FDA Description: Plethora of data formats and conventions Many different computer systems for data entry at their sites (for various trials), each of which uses different data conventions Inefficient Multiplies the potential for error Makes data sharing & mining impossible 5

6 History March 16, 2004 FDA white paper: Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products Describes the Critical Path to make product development more predictable and less costly Publishes 76 opportunities for improvement #45 Consensus on Standards for CRFs 6

7 Project Snapshot 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 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

8 CDASH Purpose & Scope To develop a set of content standards (element name, definition, metadata) for a basic set of global industrywide data collection fields that support clinical research The initial scope - safety data/domains These safety domains cut across all therapeutic areas (TA independent) Follow CDISC Operating Procedure for Standards Development (COP-001)... and make certain that all SDTM required variables are addressed AND that all CDASH collection fields map into the SDTM 8

9 Practical Benefits Eliminates some of the variety in CRFs seen at sites Streamlines training & increases common understanding of CRF completion instructions Reinforces collecting only key data Reduces collection of duplicate data - decreasing the potential for error 9

10 Practical Benefits (Continued) Minimizes data queries Facilitates populating CRFs by ehr without reentry Cuts down on study start time for all stakeholders Better quality 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; Reviews 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 How Was CDASH Developed? Started with Study Data Tabulation Model (SDTM) Focused on CRF Content, not CRF Layout Referred to ACRO CRF Samples Collected > 150 CRF samples Evaluated commonalities/differences of CRF samples Documented data points included/excluded with justifications 12

13 How Was CDASH Developed? (Continued) Agree on basic data collection fields Map to SDTM Terminology - proposals shared with the Terminology Team Write definitions and completion instructions for clinical site and Sponsors Proceed to the next step in the Consensus Process 13

14 CDASH Delivers Data Collection Tables, not CRFs Data ollection Field Variable Name (CDASH variable name shaded) Definition Case Report Form Completion Instructions Additional Information for Sponsors CDASH Core col/study ifier STUDYID Unique Identifier for a study within a submission. Not applicable. This is typically pre-printed/prepopulated. Highly Recommended dentifier in a Study SITEID Or SITENO Unique identifier for the study site; however, SITEID is also unique within a submission. Record your clinical site s identifier as defined by the sponsor. Paper: This is typically pre-printed in the header of each CRF page for single site studies. For studies with multiple sites, this field is typically left blank so that the number can be recorded by the site. Highly Recommended EDC: This should be prepopulated. If SITEID is not used, SITENO should be used to derive SITEID for SDTM, depending upon sponsor s site identification scheme. ect Identifier SUBJID Subject identifier for the study. Record the identifier for the subject. Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be provided to the site using a prepopulated list in the system. Highly Recommended 14

15 CDASH Delivers Domain Tables Basic data to be collected.. Describes the purpose of the data collection field CRF Completion Instructions for Sites How to implement the CRF data collection variable CDASH Core Designations 15

16 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. 16

17 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) 17

18 Who Participated? 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 18

19 Key Collaborations Internal CDISC cross-team CDISC SDS (Study Data Standards)Team CDISC Terminology Team NIH-NCI-caBIG project Healthcare Link Integrating the Healthcare Enterprise (IHE) Reduces need to enter study data multiple times 19

20 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Survey of Domains Practical Implementation Wrap-up and Q & A 20

21 CDASH Version

22 CDASH V1.0 Table of Contents Sections 1. Orientation Purpose Organization of Document 2. CDASH Alignment with Other Standards SDTM CDISC Controlled Terminology Other Standards (Beyond CDISC) 3. Best Practice Introduction to Best Practices Recommended Methodologies for Creating Data Collection Instruments Recommended CRF Development Workflow FAQs on Best Practices for Creating CRF Content and Structure 4. Overview of CDASH Domain Tables Introduction Data Collection Fields Considered not Necessary to Collect Core Designations for Basic Data Collection Fields/ Explanation of Table Headers 5. CDASH Domain Tables Common Identifier Variables Common Timing Variables 22

23 CDASH V1.0 Table of Contents (continued) Appendices 7.1 Commonly Used CDISC Controlled Terminology 7.2 Regulatory References 7.3 CDASH Project Development Process 7.4 CDASH Core Team Members and Participating Companies 7.5 List of Abbreviations and Glossary 7.6 Acknowledgements 7.7 Revision History 7.8 Intellectual Property 23

24 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Survey of Domains Practical Implementation Wrap-up and Q & A 24

25 Survey of Standards 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) 25

26 Survey of Standards Core Designations Highly Recommended A data collection field that should be on the CRF (e.g., a regulatory requirement, if applicable) (e.g. Adverse Event Term) Recommended/Conditional A data collection field that should be collected on the CRF for specific cases (may be recorded elsewhere in the CRF or from other data collection sources) (e.g. AE Start Time) Optional A data collection field that is available for use if needed (e.g. Was any AE experienced?) 26

27 Expectations Highly Recommended data collection variables should always be present on the CRF Sponsors will need to add data collection fields as needed to meet protocol-specific and other data collection requirements (e.g. therapeutic area specific data variables and others as required per protocol, business practice and operating procedures) 27

28 CDASH Domain New Ideas Physical Examination (PE) Inclusion/Exclusion (IE) Use PE form to record only whether or not exam was done Record Baseline abnormalities on appropriate CRF: Medical History, Targeted Medical History, or Baseline Conditions Record Post-baseline abnormalities or baseline conditions that worsened on AE CRF Use IE form to collect only the criteria NOT MET for Inclusion/Exclusion criteria 28

29 CDASH Domain New Ideas Protocol Deviations (DV) Avoid creating a protocol Deviations CRF This information can often be derived from other CRF domains or system functionalities. Comments (CO) Avoid the creation of a General Comments CRF which collects unsolicited comments. 29

30 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Survey of Domains Practical Implementations Wrap-up and Q & A 30

31 How could 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 within a proprietary file format Excel, Word, Proprietary EDC system format Potentially unstructured Use within Machine-Readable Metadata CDASH represented in CDISC Operational Data Model Vendor neutral system with an independent format Hierarchical structure is ideal for re-usable library of Components 31

32 What is a CDASH-ODM Form Composed Of? <ODM> <Study> <Meta </Meta </Study> </ODM> 32

33 CDASH AE Form in ODM No more hand building of this 33

34 Multi-Vendor Visualizations PhaseForward 34

35 Multi-Vendor Visualizations Medidata 35

36 Multi-Vendor Visualizations Paper 36

37 Implementing CDASH No Standards? No problem. Existing Standards? 1. Gap Analysis do not forget terminology! 2. Negotiation 1. Internal stakeholders 2. External stakeholders 37

38 CDASH and cabig: CRF Harmonization NCI/caBIG CRF modules will (at a minimum) include all CDASH mandatory questions NCI mandatory PLUS Additional content that is essential in the oncology space. CDASH mandatory 38 Highly recommended 38

39 Introduction to the CDASH Standard Monday, March Welcome and Review of Agenda CDASH History & Status Preview of CDASH V 1.0 Document Best Practice Recommendations Survey of Domains Practical Implementation Wrap-up and Q & A 39

40 Focus 2009 Develop CDASH Training Program Collect feedback from Early Implementers Develop and Publish Machine Readable Metadata Develop basic data collection fields for Devices Develop and Publish CDASH-Implementation Guide Update CDASH v. 1.0 Present, publish and train the CDASH standard 40

41 Thanks to all the volunteers who have worked to get us where we are today! 41

42 CDASH Core Team Members Rhonda Facile Gary Walker Dorothy Dorotheo David E. Tatum Paul Bukowiec Trisha Simpson Shannon Labout Liz Nulton-Bodiford Jay Leeka Alec Vardy Kim Truett Holly Peterson Kit Howard Cathy Schleuning 42

43 CDASH Core Team Members Lorna Griffin Lauren Shinnaberry Melissa Binz Charlene Dark Jennifer Price Chandra Wooten 43

44 Strength through collaboration 44