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Home » FDA PLANS REVIEW OF TRIAL SUBMISSIONS MODEL
FDA PLANS REVIEW OF TRIAL SUBMISSIONS MODEL
January 7, 2005
The FDA next month will hold a public meeting to review the status of the Study Data Tabul-ation 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).