Review by Richard Lehman – 06/10/2020 – 12:03pm

Data Request Number: 2020-4341 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):

This is a fascinating enquiry but may yield no cases of the primary diseases, given their rarity. If the full CSRs are already available and searchable for LD and listeriosis, this should be easy to ascertain. If not, then I think the data holder would need to make a judgement.

 Recommendation for this data request: Not Approve

see comments above. I think it is a worthwhile enquiry provided the trial databases are already easily searchable for the conditions in question.