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

posted by Brus – Spain, 2020-09-01 09:06 (507 d 12:58 ago) – Posting: # 21905
Views: 1,497

Dear Obinoscopy,


2 Years for ICH? Where did you find that?

I do not know the requirement of the Turkish agency. For our clinical trial we have followed the EMA criteria since our dossier will be presented in European agencies.



The EMA's criteria regarding the TMF has been specified in a recent guideline. Retention time appears in section 6.3:

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf

Complete thread:

Activity
 Admin contact
21,834 posts in 4,569 threads, 1,554 registered users;
online 19 (1 registered, 18 guests [including 6 identified bots]).
Forum time: Friday 21:04 CET (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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