Review by Joseph Ross – 09/22/2015 – 6:31pm

Data Request Number: 2015-0565 Please use this space to provide any comments, feedback or concerns (optional):

Discussion with the investigators included explaining that reasons for screen failure are not uniformly reported for all screened patients and that they may not be able to examine predictors of screen failures, as little (to no) other information was routinely collected on screened patients (such as demographics or clinical history). That said, investigators have revised their proposal, noting data limitations, and will conduct analyses to the best of their ability given the data.

Recommendation for this data request: Approve