Bioequivalence and Bioavailability Forum

Dear Rajdeep and Dan,

I agree with Dan: no consequence on the trial data / bioequivalence evaluation as you will be using real sampling times. Whether you consider it as a protocol deviation or not is another question, but as anyway you will have in your report a table listing all sampling time deviations it is not really an issue.

If a subject arrives late for an ambulatory sample you can't really help it. It may result in a protocol deviation, but it's not your fault. All you can do is remind the subject to come on time for the next sample. But I'm more uncomfortable about samples taken early. The subjects have been informed about the protocol constraints and they have given their consent. If the subject arrives early and you take the sample before the scheduled time, then you deliberately and voluntarily violate the protocol... which would be a GCP violation. Of course that's better than having a subject drop out, but I think you really should avoid taking the sample too early.

Regards
Ohlbe