Bioequivalence and Bioavailability Forum

Dear Dixit,

❝ As per ICH E6 - section 5.14 The sponsor should not supply an

❝ investigator/institution with the investigational product(s) until the

❝ sponsor obtains all required documentation (e.g., approval/favorable

❝ opinion from IRB/IEC and regulatory authority(ies)).

As per CDSCO GCP Section 3.1.9 The Sponsor should not supply an Investigator / Institution with the Product until the Sponsor obtains all required documentation (e.g. approval / favourable opinion from Ethics Committee and Regulatory Authorities).

All the applicable guidelines says that the IPs shall not be sent to CRO and this responsibility lies with the Sponsor.

But If the sponsor doesnot comply the regulations and sends the Inestigational products prior to IRB approval CRO shall have written procedures for the receipt and handling of of Investigational products (whether to receive or not to receive the IPs prior to IRB approval).


Thanks & Regards
KK

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Edit: Quoted text restored. [Helmut]