CDISC Standards in CDER: An Informal Survey
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*Chris Holland, FDA 

Keywords: CDISC, SDTM, data standards

Four years have passed since the Study Data Tabulation Model (SDTM) was first referenced in the eCTD study data specifications as as being a standard that "FDA currently accepts". Since this time, trends suggest that industry has been steadily adapting to this data standard for regulatory submissions. Little information exists, however, regarding how many NDAs and BLAs have been submitted in this format to CDER and, perhaps more importantly, how have these data structures been perceived by the reviewers who have had to work with them. In this talk, I will report on results from an informal survey among statisticians in CDER regarding their experiences in working with SDTM data as a part of their review of regulatory submissions for marketing authorization.