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Substantial or non-substantial modification in clinical studies

#1
Hello!

Can anyone tell me whether there is some guidance as to when to consider a modification to a clinical study protocol as substantial or non-substantial?

Thank you!
 
Last edited:

FoGia

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#2
ISO 14155 provides some guidance. I won't quote the standard here but in essence you have to look at impact of the modifications on the safety and the validity of your trial.
 
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