CDISC Awarded Contract For Training Of FDA Reviewers

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Medical Students / Training
Article Date: 21 Sep 2008 - 0:00 PDT

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The Clinical Data Interchange Standards Consortium (CDISC), announced today that the Food and Drug Administration (FDA) selected CDISC, via a formal RFP process, to provide training to FDA reviewers of regulatory submissions. The courses to be taught over the next two years will include CDISC Basics, the CDISC Study Data Tabulation Model (SDTM), the CDISC Analysis Data Model (ADaM) and Advanced Topics on CDISC Standards.

CDISC SDTM is the content standard for regulatory submission of case report form data from clinical research studies. It is cited as a data specification in FDA Final Guidance to the Industry. CDISC ADaM is the standard used to provide reviewers with the statistical analysis data and results. CDISC and its member partners for this training - Octagon Research Solutions, Destiny Corporation and Maximum Likelihood Solutions - will provide classroom as well as web-based virtual training for the requested courses.

"CDISC is extremely pleased to have been selected to continue to provide CDISC standards education within FDA, an acknowledgement of the value these standards bring to the review process," stated Dr. Rebecca Kush, CDISC President and CEO. "And, CDISC standards can bring additional value to clinical research sponsors if implemented in the clinical study start-up stage." According to Dr. Edward Helton, Chair of the CDISC Board of Directors and Associate Director, Clinical Trials Programs and Products, NCI Center for Biomedical Informatics and Information Technology, "This is another indication of FDA's support for the CDISC standards, which are included as the data specifications within the FDA's eCTD guidance document."

About CDISC

CDISC is a global, multidisciplinary, non-profit organization that has established open global standards to support the acquisition, exchange, submission and archive of medical research data. The CDISC mission is to develop and support platform-independent 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. The CDISC standards are freely available via the CDISC website at http://www.cdisc.org.

CDISC