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Hello everyone! This is Vanessa Montanari from the clinical research blog.

You found an undeclared SAE at least four weeks ago on the site, what can you do?

First of all, if the CRC is present, the best thing to do is to ask her to complete the SAE immediately for submission. If the investigator is present, the investigator should also be asked to sign the serious adverse event. If the investigator is not present, this is not a problem. You send it anyway, to the VP department immediately. Complete even without the doctor’s signature. If the CRC is not there, if the doctor is not there, you have to make the decision to send the completed SAE. You complete the SAE yourself and send it. Either way, it will be corrected later by the centre if there is an error or problem.

The next step is to retrain the investigator and the CRC, because if they have left an SAE on the site for four weeks without reporting it, there is a problem. So they have to be re-trained and you have to document that training on a training form so that you can go up in case there’s a concern afterwards that you’ve trained the centre well and they were aware, they were trained on the initiation notice, they’re re-trained a second time.

Lastly, you document all this in your monitoring report and in your follow-up letter so that the investigator is clearly informed that there has been a deviation from good clinical practice and that he must be careful for the next few times.

I hope that this will not happen to you, and I wish you good luck with your monitoring visits.

See you soon!

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