FDA SEEKS PARTICIPANTS FOR PILOT PROJECT ON TRIAL DATA SUBMISSIONS
The FDA is searching for volunteers to participate in an agency pilot project to evaluate the Study Data Tabulation Model (SDTM) and Implementation Guide that sponsors of human-drug clinical trials can use to submit data to the agency.
The FDA adopted the SDTM, developed by the Clinical Data Interchange Standards Consortium, to accelerate the agency's review of clinical trial data and new drug applications. The agency said it expects the model will provide a consistent framework for government, academia and industry to enhance data integration opportunities and reduce barriers to sharing the latest clinical trial data.
Firms interested in volunteering for the pilot project must submit written requests to participate to the agency by Feb. 28. The requests can be submitted electronically to http://www.fda.gov/dockets/ecomments for docket no. 2004N-0545, or mailed to the FDA at 5630 Fishers Lane, Rockville, MD 20852.
To view the notice announcing the pilot project, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0545-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0545-n000001.pdf).