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In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records...

In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC’s review after a trial has been completed?

A.

At least 3 years

B.

At least 15 years

C.

Until the regulatory authority has approved the investigational product for use

D.

Indefinitely

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