CDASH Clinical Data Acquisition Standards Harmonization

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Joanna Robinson
6 years ago
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1 CDISC Italian User Group Meeting 16 November 2007 CDASH Clinical Data Acquisition Standards Harmonization 1

2 Outline Background Organization Goals Timelinesand Process Review of progress Results Future 2

3 FDA Critical Path Initiative CDASH is in follow-up to FDA Critical Path Initiative. Opportunity #44 Development of Data Standards Currently, clinical investigators, clinical study personnel, data managers and FDA reviewers must cope with a plethora of data formats and conventions Lack of standardization is not only inefficient, it multiplies the potential of error Opportunity #45 - Consensus on Standards for Case Report Forms Clinical trial data collection, analysis, and submission can be inefficient and unnecessarily expensive. Standardization of the look and feel of case report forms could reduce these inefficiencies and also help accelerate progress toward electronic data capture and submission. 3

4 CDASH Project Organization Effort initiated by ACRO Project led by CDISC 2006 Formation of Collaborative Group Association of Clinical Research Organizations, National institutes of Health, Pharmaceuticals Research Manufacturers Association, American Medical Informatics Association, Critical Path Institute, National Clinical Research Resources, Clinical Research Forum, Baylor College of Medicine, Society of Clinical Data Management, National Library of Medicine, National Cancer Institute, Biotechnology Industry Organization, Association of Clinical research Professional, Food and Drug Administration, Clinical Data Interchange Standards Consortium, Duke Clinical Research Institute 4

5 CDASH Project Organization 5

6 CDASH Project Organization 6

7 CDASH Project Goal Develop a set of content standards for the clinical trials data collection; Limit variables to required and necessary data; Be consistent with regulatory requirements; Allow efficient data collection/storage/transmission/analysis; Be focused on CRF content, not CRF layout. 7

8 CDASH Project Practical Experience Start with SDTM Data Variables Refer to ACRO CRF samples Collect CRF samples Agreement on BASIC CRF elements Map to SDTM Add controlled terminology Write guidelines Guiding principles: Limit variables to required and necessary Comply with regulatory requirements Reduce redundancies Be appropriate for pre/post approval studies Allow consistent data collection/storage/ transmission and analysis. CDASH Packages 8

9 CDASH Project Domains Domain Adverse Events Prior Medication Concomitant Medication Demographics Subject Characteristics Physical Examination Vital Signs Medical History Substance Use In/Ex Criteria Drug Accountability/ Exposure Comments/ Protocol Dev. Disposition/End of study Lab ECG Q Q Q Q Q Q1 08 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Package 1 Package 2 Package 3 Package 4 9

10 CDASH Project Status 10

11 CDASH Package 1 Adverse Events Prior/Concomitant Medications Demography Element name SDTM Variable Controlled Term. Instructions 11

12 AEs page My experience CRF - Sponsors Requirements 12

13 AEs page CDASH Standards and Annotated version 13

14 PRIOR/CONCOMITANT MEDICATIONS page My experience CRF - Sponsors Requirements 14

15 PRIOR/CONCOMITANT MEDICATIONS page CDASH Standards and Annotated version 15

16 DEMOGRAPHY page My experience CRF - Sponsors Requirements 16

17 DEMOGRAPHY page CDASH Standards and Annotated version 17

18 CDASH Value of Standard Implementation Faster CRF design and e-crf setup/implementation: CRF form = Dataset domain CRF field = Variables label List of codes in the CRF = Standard controlled terms Auto-generation of CRFs No need to data conversion or disparate data formats integration for reporting or submission purposes. Process integration: standards are used from CRF design to database set-up and XPT files generation for esubmission 18

19 Future Standardize layout Standardize edit language Standardize basic therapeutic area data elements New Domains to be CDASHed Update of CDASH developed domains Training 19

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

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