Bioequivalence and Bioavailability Forum

Dear ElMaestro,

This thread has generated so many comments from enthusiastic crowds that I can't resist adding my twopence.

I think that just like most of the rest of ICH E6, the few bits and pieces on central monitoring were written with Phase 2-3 trials in mind. Or at least, multicentre studies using eCRF (not necessarily EDC systems for patient reporting outcome, such as these nice e-diaries where you can so easily see that all data from a 3-month period were entered on the day before the next visit to the Doc, or even while at the trial site because the Study Nurse is not happy).

I don't quite see the applicability to BE trials. Particularly considering the way the monitoring of BE trials is often organised in my experience: visits during the trial conduct, which are half-way between monitoring and in-process auditing, and quite different from the way they are done in Phase 2-3.