medical event before dosing [Study Per­for­mance]

posted by drsatishmc – 2011-06-14 12:34 (5081 d 09:36 ago) – Posting: # 7121
Views: 5,316

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
23,424 posts in 4,927 threads, 1,671 registered users;
61 visitors (0 registered, 61 guests [including 33 identified bots]).
Forum time: 22:10 CEST (Europe/Vienna)

If you shut your door to all errors
truth will be shut out.    Rabindranath Tagore

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