CDISC Announces the Publication of CDASH Version 1.0 - Standard for Clinical Research Study Data Collection.

AUSTIN, Texas -- The Clinical Data Interchange Standards Consortium (CDISC) announces the publication of version 1.0 of a standard for the collection of safety data for clinical research studies, the Clinical Data Acquisition Standards Harmonization (CDASH) Standard. This project was classified as an opportunity of the Food and Drug Administration's (FDA) Critical Path Initiative, which was spearheaded by Dr. Janet Woodcock through the Commissioner's Office. "This is an important milestone in the effort to streamline 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 current variation in data collection requirements across different research study sponsors introduces confusion, opportunities for error and inefficiency at sites participating in clinical research, thus deterring participation in research studies. Broad adoption and implementation of this standard for case report forms (CRFs), especially electronic CRFs, would improve data quality and simplify the research process for investigators, and all other stakeholders in clinical research including electronic health record providers who wish to support clinical research. Since the CDASH standard is harmonized with the CDISC Study Data Tabulation Model (SDTM), the content standard for regulatory submission of case report form tabulations referenced in FDA e-Submission Guidance, use of CDASH v 1.0 is also expected to streamline the preparation and review of regulatory submissions.

The data collection standards project was initiated by the Association of Clinical Research Organizations (ACRO) in collaboration with FDA in 2005. In 2006 CDISC was asked to assume the project leadership role, in recognition of its success as an open, global, standards development organization, working with a collaborative group of seventeen organizations. The CDASH project has been successful through the significant contributions of this collaborative group and the approximately 200 active volunteers. "Having been involved with the project since its inception, ACRO is extremely pleased by the publication of CDASH v 1.0.," said Doug Peddicord, Executive Director of ACRO. "Streamlining data collection and improving data interoperability represents a critical step toward improving the clinical research process and we salute CDISC and all the stakeholders on a job very well done. We look forward to further development of the CDASH standards and, importantly, to their broad dissemination and implementation."

Another CDASH Collaborative Group member with participation on the CDASH teams was the National Cancer Institute's (NCI) Cancer Biomedical Informatics Grid (caBIG[R]) program. CDISC and caBIG[R] were able to collaborate on the complementary CDASH and NCI caBIG[R] CRF. The harmonization projects were successful to the extent that the CDASH fields are now a subset (safety data fields) of the caBIG[R] recommended data collection fields for oncology research studies.

The consolidated CDASH Standard Version 1.0 document is the result of a global, consensus-based standards development process which received 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 all types of clinical research. The document also includes implementation recommendations, best practice guidelines, regulatory references and other information on the CDASH project. It is posted and freely available in the standards area on the CDISC website at www.cdisc.org.

About CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established global standards to support the acquisition, exchange, submission and archive of clinical research data. The CDISC mission is to develop and support platform-in dependent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC has a Charter Agreement with HL7, in place since 2001, with a commitment to harmonize clinical research and healthcare standards. CDISC has Liaison A status with ISO TC 215 for Healthcare Standards and has been accepted as a member of the Joint Initiative Council (JIC) along with HL7, ISO, and CEN.