I recently had an email about whether or not our university is auditing ClinicalTrials.gov submissions. The person said she had been trying to research this and was finding that not many people actually audited submissions. I was wondering if you had any further information on this?

I’m not entirely sure about the email regarding auditing ClinicalTrials.gov submissions. I have participated with the DIA and others to construct a survey that deals with disclosure operations and policies for both industry and academia. Perhaps this is what you mean? In my experience, I have found that academic medical institutions/academic research organizations lag substantially behind in terms of preparing protocol registrations/results records and generally have not constructed institutional disclosure policies and compliance tracking to minimize risk to the organization. This is the type of work I do (although I choose the term “assess” rather than audit because I am not an accountant and do not do financial risk audits) and I am currently working with both industry and academia to assist them with their disclosure efforts.