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Home » FDA Lacks Experience With SDTM Submissions, Officials Say
FDA Lacks Experience With SDTM Submissions, Officials Say
February 2, 2005
The FDA is eager for industry to implement the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) so reviewers can gain experience with the standard, but industry has been slow to respond, FDA officials said at a Feb. 1 public meeting at agency headquarters in Rockville, Md.