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Patrick R. Ayd, BSN, MBA

Advisor: Clinical Sites

FDA or ICH-GCP Guidelines

I receive many questions regarding whether or not the FDA or ICH-GCP guidelines requires AE or Protocol Deviation logs for a clinical trial. As you all know, what the FDA expects is somewhat vague at best, it is my opinion that creating these logs add a great deal of efficiency, quality and clarity to your clinical trial documentation.

An AE log allows the clinical research coordinator (CRC) and the Principal Investigator (PI) the ability to take a quick look to see how the AE’s might be trending for a trial. If the CRC hands an AE form to the PI to assess and sign once every three weeks the PI could rate each AE is “unrelated”. If there had been an AE log the PI might see a pattern of AE’s and begin to rate them differently.  For the CRC the AE log is a great tool to look at when doing a participant’s last visit. The CRC can take a quick look to make sure that all of the participant’s AE’s are closed or reassessed to end that portion of the documentation for the clinical trial.

A Protocol Deviation log holds a similar purpose. The site’s PI or clinical management team can take a quick look to see the types of protocol deviations that are occurring and assess if there are trends they need to address. This could include retraining staff, working with the sponsor, changing source documents, etc. A Protocol Deviation log also ensures that the IRB has been notified as appropriate for any protocol deviations that were made.

So even though there is no FDA guidance or ICH-GCP verbiage that requires these types of logs, these logs remain important tools. The logs go a long way in helping a clinical site stay on track and keep up with efficient quality operations which is key to each site’s success.  Contact Us

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