CDISC Standards in CDER: An Informal Survey
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC