Bioequivalence and Bioavailability Forum

Hi Prashant

Based on your in house SOP the decision should be taken .

In general, as non compliance is the reason for dropping out the subject and if there is any provision in your system for addressing non compliance, relevant form to be filled up. Protocol deviation generally be done when subject still allowed for the study and to assure the regulatory that deviation has not affected the outcome in a significant way.

Again, it can vary for different organization. The main concern to be reporting of the non compliance.

Other suggestion is welcome .

Thanks

Bani
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Edit: Full quote removed. Please see this post! [Ohlbe]