Review by Nihar Desai – 10/07/2016 – 2:29pm

Data Request Number: 2016-1026 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):

This proposal still remains nebulous to me — I find the SAP very difficult to follow.  They have attached a number of additional files, including a grant application to PCORI but I remain unclear about what trials are requested, how they will be analyzed, and what the key outcomes are.

Recommendation for this data request: Not Approve