medical event before dosing [Study Per­for­mance]

posted by drsatishmc – 2011-06-14 12:34 (5496 d 03:43 ago) – Posting: # 7121
Views: 6,426

Dear all

If a medical event takes place after checkin but before dosing it is not an AE as per ICH GCP. So how we have to capture that.

Regards
satish


Edit: Category changed. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
252 visitors (0 registered, 252 guests [including 16 identified bots]).
Forum time: 16:18 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5