Data Request Number:
2016-0969
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?:
Unsure, would defer to Data Holder Due Diligence Assessment
Please use this space to provide any comments, feedback or concerns (optional):
Key for this proposal is whether pharmacokinetic data are available for trial participants for each of the 4 requested studies, and how often pharmacokinetics were measured. I defer to data holder on this issue, but if these data are available, the proposal is clear and will generate important scientific information.
Recommendation for this data request:
Approve
