Clinical Data Acquisition Standards Harmonization (CDASH)

Call for Public Review: CDASH Draft Data Collection Data Variables

CDISC Leads Harmonization Efforts to Standardize Elements for Data Capture

Access the CDASH Webinar held January 22, 2007

The Clinical Data Acquisition Standards Harmonization (CDASH) initiative, led by CDISC, supports clinical and medical research by streamlining data collection in a way that promotes improved data interoperability throughout the biomedical research and product development processes, and enhances the interface with healthcare and EHR.  CDASH is focused on the development of consensus-based ‘content standards’--specifically: element name, definition, and metadata -- for a basic set of global data collection fields based on the CDISC SDTM model.  The initial scope of the project is focused on the ‘safety data domains’ to support clinical and medical research and safety reporting.

CDASH was first announced by Dr. Janet Woodcock, (FDA), at the 2006 DIA Annual meeting.  The CDASH project focuses on the FDA Critical Path Opportunity #45, and is supported by a collaborative group of organizations comprised of the Association of Clinical Research Organizations (ACRO), the Association of Clinical Research Professionals (ACRP), the American Medical Informatics Association (AMIA), Baylor College of Medicine, the Clinical Data Interchange Standards Consortium (CDISC), the Clinical Research Forum, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), (the Clinical Research Policy Analysis and Coordination Program, the National Cancer Institute (NCI-caBIG and NCI-EVS), the National Clinical Research Resources (NCRR), the National Library of Medicine (NLM), the National Institute of Child Health & Human Development (NICHD)), the Critical Path Institute, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotech Industry Organization (BIO), the Society for Clinical Data Management (SCDM) and Duke Clinical Research Institute.

CDISC held the CDASH project kick-off meeting in October 2006 to initiate the first three project streams (sub-groups), and to organize interested volunteers into working groups aligned with these project streams. Over 70 representatives from Contract Research Organizations (CRO), eCROs, Academia, Government and Industry participated in the project kick-off meeting.  A total of 9 streams have been initiated and working since then. They have developed initial consensus versions for the following safety data domains: adverse events, concomitant medications, demographics, subject characteristics, inclusion/exclusion criteria, medical history, substance use, physical exam, vital signs, drug accountability, exposure, comments, protocol deviation, disposition/end of study, lab and ECG.

Additionally, a CDASH webinar, “CDASH – Building Global Consensus to Define CRF Standards” was held January 22nd, attracting over 330 participants, including 53 international attendees. The CDASH webinar is archived for on demand viewing by visiting http://www.bettermanagement.com/seminars/seminar.aspx?l=14301.

All CDASH domains are scheduled to go out for public review in Q1 2008.  Once published for public review, we ask that you review these domains and give us your comments!

For more information on the CDASH project and how you can get involved in this effort, visit http://www.cdisc.org/index.html or contact rfacile@cdisc.org.