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Good Clinical Practice (GCP) Questions and Answers - Agreements

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India: Sponsor-Investigator Agreements

Indian GCP guidelines - Section 3.1.3. states: "The Sponsor and the Investigator(s) should sign a copy of the protocol and the SOPs or an alternative document to confirm their agreement". I would be grateful if the members of the GCP Committee could share their understanding of this statement.

Ref: KW03 Date: 26th February 2013

Investigator responsibilities are generally covered in the protocol for the clinical conduct of the study and in the contract for the investigator responsibilities, e.g. which regulations to follow, which documents to provide when etc. Since the investigator and the sponsor signs the contract and the protocol, this would be sufficient to document delegated and accepted responsibilities. Therefore, the contract could be considered as ‘an alternative document to confirm their agreement.’ Signing such an agreement also complies with sections 3.3.1 and 3.3.5 of the GCP Guidelines.

Other potential considerations are pharmacy responsibilities which can also be covered in the contract. However, some sites require a separate pharmacy agreement.

If there truly is a process that needs to be agreed specifically for the site or study, then it could be covered in protocol or contract – or if needed, in a study specific SOP. Here it might be required to have the investigator and sponsor signature if the process is covering both.

There are some sites that have some site specific SOPs and here it would need to be evaluated if they are in line with protocol/study and other requirements and it would need to be determined what is being done if there are discrepancies, and also if they are following in addition to sponsor Sops or instead. This should be documented in the contract.

 

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