Missing periods in replicate designs [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2019-10-16 17:10 (1516 d 14:08 ago) – Posting: # 20693
Views: 9,148

Hi Hötzi,

❝ I would say:

Did you see cases like this? And if yes, do you know why?

Not a definitive answer, but at some CROs they have SOPs in place to the effect of allowing subjects to come back after they have skipped a period , or fractions of one. This, I think, relates originally to FDA's data driven policies. A subject can walkout on her/his own initiative without even stating a reason, that's how GCP works. There is no clause saying she/he can't come back.
I know, this is messy, but that's the way it is in some clinics.

The alternative may be worse, depending on how you look at it: If a subject misses an ambulatory pk-sample ("I forgot", "I sat stuck in a traffic jam", "My parrot suffered an anxiety attack", "Don't you fucking ask me what I did yesterday, it's none of your business", "I had to watch Conchita Wurst win the Grand Prix" etc.) should she/he then be considered completely out?

Pass or fail!

Complete thread:

UA Flag
 Admin contact
22,823 posts in 4,786 threads, 1,633 registered users;
27 visitors (0 registered, 27 guests [including 6 identified bots]).
Forum time: 06:18 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz