Review by Joseph Ross – 02/09/2015 – 4:56pm

Data Request Number: 2014-0287 Please use this space to provide any comments, feedback or concerns (optional):

The revised proposal is much clearer. However, I am concerned that the investigator is requesting the data outside of the secure data sharing platform. Given that J&J is unlikely to grant this access, perhaps the requester should be asked to provide further detail on why it’s necessary or whether they are still interested in obtaining access to the data if it can only be made available via the secure data sharing platform.