Bioequivalence and Bioavailability Forum

Dear Dixit
It all depends on the company policy and SOPs if you have one to receive the IPs. Most sponsors send the IPs once after the protocol is finalized.
But some sponsors send them before the finalization of the protocol, it all depends on the comfort levels with the CRO and the sponsor. If the sponsor is tied up with a CRO, he can supply the IPs once after all the formalaties are completed [import licence, etc].
Hope you can decide on how to go about.
Thanks
Suds

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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)).

So as per my opinion it IP shoould be received after protocol approval

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]