External Review by Jim Neaton – 08/07/2016 – 9:46am

Data Request Number: 2016-0994 Is the scientific purpose of the research proposal clearly described?: Yes Will proposed research 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 Does proposed research provide strong rationale for why the requested data can uniquely be used to address the proposed project aims? Yes Does proposed research provide clear justification for access outside the secure data sharing platform?: Yes Does proposed research describe the protections in place to ensure data security outside of the platform?: No If no, please explain:

The request does not specifically address 2 of the points identified for data outside the secure platform — justification for request and security.

The reasons appear to be able to combine the data with other data sources and to use the flexMIRT software instead of SAS. I am not familiar with item analysis so cannot judge how essential the flexMIRT software is for their research. SAS does have item analysis routines. An alternative to using obtaining the data and pooling it with the other data they mention would be to compute summary statistics in SAS and pool the summary statistics.

I am sympathetic to their request. It is easier to use software you are familiar with and also easier to do that with the raw data from trial they propose to use. Their proposal seems well thought out (although I am not an expert in this area). Thus, I would grant their request if they address the security of the data outside of the platform.

 Please use this space to provide any comments, feedback or concerns (optional):

See comments above.

 Recommendation for this data request: Approve