CDISC Team Honored With FDA Award

The Submission Data Standards (SDS) Team of the Clinical Data Interchange Standards Consortium (CDISC) received the Food and Drug Administration’s Leveraging/Collaboration Award at the Office of the Commissioner Honor Award’s Ceremony on 10 June 2005. The award was given to CDISC for the “creation of the standard Study Data Tabulation Model (SDTM) and accompanying implementation guide for submission of data tabulation datasets to the FDA.”

The award, presented by Acting FDA Commissioner Lester Crawford, was accepted by Mary Lenzen and Wayne Kubick on behalf of the entire SDS team, including honorary SDS member Rebecca Kush and more than 25 current and past team members, many of whom were in attendance. “CDISC is very grateful to the FDA for acknowledging the extraordinary efforts of the many individuals who contributed to the SDTM,” said Wayne Kubick (Lincoln Technologies), Leader of the SDS team and CDISC Technical Director. “This was truly a team effort, and we believe it will yield many benefits to FDA and industry for years to come.”

“The SDS team exemplifies, as do all CDISC teams, the nature of the CDISC consortium to interact collaboratively to achieve our goals” said Rebecca Kush, CDISC President. “The SDS team included representatives from over 20 different companies in the biopharmaceutical industry, who worked very hard for the greater good of the industry and the patients who are recipients of their products. We are very proud of their demonstrated achievements.”

In July 2004, Dr. Lester M. Crawford, Acting FDA Commissioner announced the desire of the FDA to receive data in a standard format, the SDTM. "The importance of a standard for the exchange of clinical trial data cannot be overstated," said Dr. Crawford, "FDA reviewers spend far too much valuable time simply reorganizing large amounts of data submitted in varying formats. Having the data presented in a standard structure will improve the FDA's ability to evaluate the data and help speed new discoveries to the public.”
The SDTM standard has been added to other specifications listed under the draft guidance "Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions" on the FDA Web site at http://www.fda.gov/cder/regulatory/ersr/ectd.htm.

In March 2005, FDA added CDISC’s “define.xml” to the acceptable formats for transmitting SDTM metadata in XML format to the agency. Information is available at http://www.fda.gov/cder/regulatory/ersr/Studydata-v1.1.pdf and the CDISC web site: http://www.cdisc.org/models/def/v1.0/index.html Define.xml is based upon the use of CDISC Operational Data Model (ODM) transport standard.

CDISC is an open, multidisciplinary, non-profit organization committed to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

CDISC is made possible through the generous support of its members, sponsors, and volunteer participants. Additional information on CDISC and the CDISC open standards/models can be found on the CDISC website at www.cdisc.org. CDISC will hold its annual U.S. Interchange Conference on 20-21 September in Bethesda, MD. Further information about this event can also be found on the CDISC website.

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