Review by Joseph Ross – 05/21/2019 – 11:43pm

Data Request Number: 2019-3864 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):

This is an interesting proposal to examine clinical trial and observational data from multiple sources to identify the common data elements needed/used to evaluate medications used to treat HIV/AIDS. My only caution is in wondering whether access to IPD are necessary for this proposal. Wouldn’t provision of blank CRFs, used to collect data throughout the trials during the multiple points of follow-up, be sufficient? The investigators do not need to use the actual data; instead, they need to examine what data were collected and how those data were categorized.

Recommendation for this data request: Approve