Review by Joseph Ross – 10/06/2016 – 5:45pm

Data Request Number: 2016-1038 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):

Requester has clearly detailed plans to aggregate data in a common SAS environment, including data from GSK, UCB and Novartis trials, as well as potentially trials from Pfizer. Logistic barriers will need to be overcome for this to successfully take place.

Recommendation for this data request: Approve