FDA TO REVIEW MODEL FOR TRIAL DATA SUBMISSIONS

The FDA next month will hold a public meeting to review the status of the Study Data Tabulation Model (SDTM) for clinical trial data submissions and to discuss the agency's experience with and plans for the proposed standard format, which was developed by the Clinical Data Interchange Standards Consortium (CDISC).

Also, CDISC will make presentations on SDTM's status, future direction and implementation challenges, and describe user experiences. The FDA expects the SDTM to accelerate clinical trial data review. Meanwhile, the FDA is seeking volunteers for an agency pilot project to evaluate SDTM.

The meeting is scheduled for Feb. 1, and participation is limited to the first 130 registrants who pre-register via email to smithlo@cder.fda.gov (mailto:smithlo@cder.fda.gov) by Jan. 15. Further meeting details are available online at http://www.fda.gov/oc/datacouncil/cdiscmeeting.html (http://www.fda.gov/oc/datacouncil/cdiscmeeting.html).

For more information about the SDTM standard, see the draft guidance, "Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Applications and Related Submissions," at http://www.fda.gov/cder/regulatory/ersr/ectd.htm, or go to the CDISC website at http://www.cdisc.org (http://www.cdisc.org).