Review by Joseph Ross – 12/12/2017 – 8:21am

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 revision of a previously submitted proposal to use matrix decomposition to predict likelihood of future adverse events based on prior adverse reactions. Several clarifications were requested, including more detail on adverse event definition, methods used, impact of excluding those who experience no adverse events, and so forth. Minor changes were made to the proposal. For a methods-oriented project, I would have preferred the investigators to provide more detail. But I believe the proposal as written is satisfactory.

Recommendation for this data request: Approve