Module 12 Presentations

26/01/2024

Background to FDA Data Requirements – Clinical (and Nonclinical)

The FDA receives massive amounts of study data

•in extremely disparate formats •using a variety of proprietary standards •largely in paper or pdf formats

This makes it extremely difficult, if not impossible, to do cross-study and application reviews

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US Requirements for Clinical Data is NOT new

•Per21CFR314.50: Item 11 Case report tabulations. •The NDA is required to contain tabulations of the data from •each adequate and well-controlled study under 314.126 (Phase 2 and Phase 3 studies as described in 312.21 (b) and (c) of this chapter), •tabulations of the data from the earliest clinical pharmacology studies (Phase 1 studies as described in 312.21(a) of this chapter), •and tabulations of the safety data from other clinical studies. •The Clinical Study Reports •Supported by Case Report Forms and Case Report Tabulations for clinical studies and tabulated data for nonclinical studies •Used for independent analysis of study data and conclusions •Paper tabulations are not “user friendly” and were replaced by sas.xpt files in 1997/1999 •Not standardized until 2004 (CDISC) •The electronic datasets take the place of these tabulations!

At the study level applicants submit:

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