Why do I have to fill out training logs every time there is a Protocol Amendment?  The answer is that you don’t.

GCP Section 4.2.4 requires “all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions”.  GCP does not specify how this training is done.   GCP does not even specify that training has to be documented. BUT, in an audit the onus is on the site to prove that training did take place, which is very difficult to do without documentation.  Remember the old mantra: if it isn’t documented, it didn’t happen!

Personally, I find the training logs the simplest way to document training but it may not work for every site.  Educational sessions with an attendance list, departmental meeting minutes and File Notes are some alternatives.  Its up to your site to work out what is best for you.



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