External Review by Richard Lehman – 07/13/2016 – 11:23am

Data Request Number: 2016-0969 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? Yes Does proposed research provide clear justification for access outside the secure data sharing platform?: Yes Does proposed research describe the protections in place to ensure data security outside of the platform?: Yes Please use this space to provide any comments, feedback or concerns (optional):

I am not clear how the pharmacokinetic modelling can be validated but this is a technical consideration. I think the proposal overall has scientific validity.

Recommendation for this data request: Approve