Review by Joseph Ross – 02/08/2018 – 7:53am

Data Request Number: 2018-2761 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):

Proposal requires access to spine x-ray and MRI interpretation, at the vertebral level – I’m not sure the data is available at this level of detail, as opposed to just the overall Stoke AS spine score and BMD. It seems like they already have the data, but are specifically asking for the DEXA scan information (see last paragraph of SAP). Please clarify with investigators and with J&J if DEXA data can be made available.
Investigators should also explain why they propose limiting their sample to an 80% random sample – why not just use the whole sample?

 Recommendation for this data request: Approve