Review by Nihar Desai – 11/22/2017 – 9:29am

Data Request Number: No Data Request Assigned 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 a very interesting project my question is about how the investigators will define adverse events.  What types of events will qualify and is there a hierarchy of events?

 Recommendation for this data request: Approve