Retention of Investigational products - EMEA [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2010-03-15 12:10 (5951 d 07:32 ago) – Posting: # 4913
Views: 4,167

Dear Prakash
You will not find a guideline telling you the requested information. It is the responsibility of the sponsor to decide how to deal with it. The following answers are based on our procedures:

❝ 1. Number of investigational product to be required for retention?

=> sufficient for two full analyses

❝ 2. Duration until which the investigational products retention should be

❝ done?

=> 5 years

❝ 3. Responsibility of the retention of the investigational product. Sponsor

❝ or CRO ?

=> Sponsor/manufacturer
I hope this helps
Dan

Edit: Standard quotes restored. [Helmut]
—
Kind regards and have a nice day
Dr_Dan

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