Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? [Regulatives / Guidelines]

posted by Obinoscopy  – USA, 2020-09-01 01:50 (139 d 20:10 ago) – Posting: # 21904
Views: 1,049

Dear Brus,

» I have recently conducted a study in Turkey, and according to the Turkish agency's calendar, a maximum of 45 days is taken to issue approval.

Thanks for this info.

Do you also know how long essential documents such as Case Report Forms (CRFs), Signed Protocols, Informed Consent Forms (ICFs), Ethics Committee Approval, etc. should be retained according to Turkey Regulatory Agency Guideline? I know it's 2 years for ICH and 5 years for Nigeria.



Complete thread:

 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 21:01 CET (Europe/Vienna)

I believe there is no philosophical high-road in science,
with epistemological signposts. No, we are in a jungle
and find our way by trial and error,
building our road behind us as we proceed.    Max Born

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