External Review by Nihar Desai – 01/22/2020 – 1:57pm

Data Request Number: 2019-4001 Is the scientific purpose of the research proposal clearly described?: Yes Will proposed research 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 Does proposed research provide strong rationale for why the requested data can uniquely be used to address the proposed project aims? No Does proposed research provide clear justification for access outside the secure data sharing platform?: No Does proposed research describe the protections in place to ensure data security outside of the platform?: No Please use this space to provide any comments, feedback or concerns (optional):

I do not believe the authors have sufficiently described the reasons for data access outside the secure platform, the data security standards and processes in place. The proposal describes the clinical situation in some detail but is lacking salient discussion of the issues above.

Recommendation for this data request: Not Approve