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

posted by Obinoscopy  – USA, 2020-09-01 01:50 (51 d 12:48 ago) – Posting: # 21904
Views: 936

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

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