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We’re doing a compliance audit of clinicaltrials.gov at our institution and are developing an audit tool/checklist for the audit. I’m wondering if anyone has established tools for this type of audit they would be willing and able to share. Thanks!
silbertl 21/02/2024 10:08 pm
@cmacpherson Are you auditing what is already registered by your institution/investigators on Clinicaltrials.gov? Or are you auditing your own institutional portfolio of IRB approved research to identify potential gaps in what should have been registered on Clinicaltrials.gov?
CMacpherson Topic starter
21/02/2024 10:23 pm
We are actually looking at both to ensure that all trials that should be listed are listed and that we have the correct contacts listed, that consent forms and results have been posted as required, etc…
silbertl 02/05/2024 10:20 pm
@cmacpherson Apologies for my extremely delayed response! I had failed to subscribe to this thread and forgot all about it. When we did our internal compliance audit (reviewing all active studies to ensure they were in compliance with FDAAA – it pre-dated other policies and requirements) for ClinicalTrials.gov compliance several years ago, we winged it in terms of audit tools/checklists because it was a one-time event. Since then we established policies and SOPs for maintaining compliance and have never felt the need to repeat the audit. Also, my team conducts all the CT.gov compliance activities regularly so it would be auditing ourselves if we were to conduct an audit of most of the items you listed.
I will say that you can run pretty useful reports in ClinicalTrials.gov if you are a PRS administrator at your institution. I would suggest using those as much as possible – it should save you some time and effort. To my great dismay (and I have complained about it a lot to the good people at the National Library of Medicine who run the public-facing site as well as the PRS), there is no easy way to track NIH funded studies that meet the registration or results reporting policy requirements. So you will need to develop your own method for figuring this out based on what your internal systems can generate so you can verify compliance.
