Review by Joseph Ross – 07/31/2020 – 4:45pm

Data Request Number: 2020-4276 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Project to meta-analyze psychiatric adverse event data among users of topiramate. Investigator is not analyzing participant-level data. Data made available for this project need only be CSRs.

 Recommendation for this data request: Approve