Bioequivalence and Bioavailability Forum • Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?

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

posted by Obinoscopy – USA, 2020-09-01 01:50 (503 d 05:04 ago) – Posting: # 21904
Views: 1,505

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.

Regards,

—
Scopy

Complete thread:

Document Retention Period for Bioequivalence study Turkish Submission yatish gosai 2020-08-10 14:36 [Regulatives / Guidelines]
- Website of the Turkish Medicines and Medical Devices Agency Helmut 2020-08-10 15:15
- Document Retention Period for Bioequivalence study Turkish Submission Brus 2020-08-31 14:21
  - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ?Obinoscopy 2020-09-01 01:50
    - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Brus 2020-09-01 09:06
      - ICH = 2 Years after last approval based on study Ohlbe 2020-09-01 11:03