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

posted by Brus – Spain, 2020-09-01 07:06 (51 d 04:38 ago) – Posting: # 21905
Views: 916

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

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