Review by Joseph Ross – 09/07/2021 – 9:57pm

Data Request Number: 2021-4764 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):

Investigators plan to compare SAE reporting in publications, trial registries and CSRs. The CSRs for these 15 trials are being requested from both the EMA and the YODA Project. I expect that they will provide the same information, but the investigators should consider what they will do if the CSRs from the two sources differ.
Also, for the YODA Project team, I was confused by the supplementary material attached to the application.

Recommendation for this data request: Approve