Review by Joseph Ross – 06/08/2016 – 5:05pm

Data Request Number: 2016-0765 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 an important proposal to develop and refine statistical methods to measure cognition in clinical research. However, there is an issue with the proposal, in that the investigators explain that individual patient data will be reformatted and merged into one central database with standard variable names and coding, with each trial being given a unique identifier. This will not be possible for the data being made available from the YODA Project, as the data must remain within the secure data sharing platform. The investigators should revise their proposal to explain how they will conduct their analyses given that the data cannot be downloaded, only summary results.

Recommendation for this data request: Approve