FDA Posts FAQs on Clinical Data Summary Pilot Program

The FDA released several frequently-asked questions pertaining to its clinical data summary pilot program.

The agency plans to post several aspects of the Clinical Study Report, including the study report body, protocol and amendments, as well as the statistical analysis plan for each pivotal study. Complete line listings of patient information and full adverse event narratives are considered outside the scope of the pilot.

In cases where the FDA must redact information from the CSR, the agency will handle the process in-house rather than through a third party. Information that may be subject to redaction includes that which pertains to trade secrets, personal privacy information and confidential commercial information.