Clinical Data Acquisition Standards Harmonization (CDASH)

Recent Progress

CDISC Announces the Publication of CDASH version 1.0

The Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.0 is now openly available for download from the CDISC website. You many also access the CDASH Public Review Spreadsheet to see the comments that were received during the review period prior to the release of CDASH version 1.0.

The published, consolidated CDASH Standard Version 1.0 document represents a global, consensus-based standards development process with comments from organizations in all of the ICH regions (US, Europe and Japan). It describes recommended (minimal) data collection sets for 16 domains, including demographic, adverse events, and other safety domains that are common to all therapeutic areas and types of clinical research. The document also includes implementation recommendations and best practice guidelines, regulatory references and other information on the CDASH project. It is posted openly in the Standards area on the CDISC website.

Background

This CDASH project is classified as an opportunity of the FDA Critical Path Initiative, which was spearheaded by Dr. Janet Woodcock through the Commissioner’s Office. "This (project) is an important milestone in the effort to move to streamlined clinical trial development and execution by using standardized electronic trial data," said Dr. Woodcock, who is now the Director, Center for Drug Evaluation and Research at FDA.

The 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, for version 1.0 release published above, 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.

Since CDISC held the first CDASH project kick-off meeting in October 2006 where the first three project streams (domain teams) were initiated, project participation grew quickly to a total of 9 streams/domain teams that have worked to collaboratively develop the collection elements for 16 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).

Presentations

Webcast in collaboration with DIA
CDASH: Standardizing CRF Data Collection Fields: An Idea Whose Time Has Come

Originally presented July 24, 2008
View archive

Next Steps

The next phase of the project is focused on the collection of feedback from ‘Early Implementers” of the CDASH standard. All implementers of the CDASH standard are invited to send feedback to Rhonda Facile (rfacile@cdisc.org). Implementation information gathered will be used to further refine and improve the CDASH standard.

Contact

For more information on CDASH, and how to get involved, contact rfacile@cdisc.org.

 


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