Review by Cary Gross – 06/05/2021 – 8:13am

Data Request Number: 2021-4698 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?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

The analytic plan suggests that this is a meta-analysis of aggregate data (including study results gleaned from the literature, as well as the requested studies available via YODA).  Yet the investigators appear to be requesting individual patient data. Is that the case? and if so, how will the IPD be used?

Recommendation for this data request: Not Approve

see above