Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-17 05:53 CEST (UTC+2h)
 
suchit_bhavsar
Regular

India,
2017-04-14 08:30

Posting: # 17238
Views: 651
 

 written consent from volunteers [GxP / QC / QA]

Hello to all of you.

As per ICH GCP E6, section No. 4.8.2 "Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favorable opinion in advance of use"

Is it required to get screening consent approved from Ethic committee before starting of the screening (in case of general screening)

Thanks in advance

Regards,
Suchit Bhavsar


Edit: Category changed; see also this post #1. [Helmut]
Ohlbe
Hero

France,
2017-04-14 18:17

@ suchit_bhavsar
Posting: # 17240
Views: 527
 

 written consent from volunteers

Dear Suchit,

» Is it required to get screening consent approved from Ethic committee before starting of the screening (in case of general screening)

Clearly: yes.

Regards
Ohlbe
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,394 Posts in 3,725 Threads, 1,071 registered users;
30 users online (0 registered, 30 guests).

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed