IEC/IRB approval [Regulatives / Guidelines]

posted by hsan – 2008-02-05 12:36 (6719 d 22:54 ago) – Posting: # 1585
Views: 2,650

Though there is no specific timeframe mentioned on the subject. A reasonable time should be there for thorough evaluation of the protocol. This depends on the design and IP and associated AE/SAEs and other work taken up by committe on that sitting. If any protocol is approved in less than 24 hours, it is doubtful.

--
Edit: Full quote removed. Please see this post and the Forum's Policy as well! [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
343 visitors (0 registered, 343 guests [including 19 identified bots]).
Forum time: 12:31 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

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