Bioequivalence and Bioavailability Forum

Dear Joy,

What I often see in protocols is that any time deviation of more than a certain value will be considered as a protocol deviation and will be reported as such in the study report. But all time deviations are reported and are considered in the PK analysis.

I have seen strange interpretations of such protocol provisions: allowed deviation ± 2 min, actual deviation + 5 min, reported deviation + 3 min...

I agree with Helmut: there is no reason why any sample should be collected early. Meaning that any sample collected early should be considered as a protocol deviation. After all, if a subject arrives late for an ambulatory sample there is little you can do; but if he arrives early you can ask him to wait. He was informed of the protocol constraints and agreed to them when signing the consent form.