Drug Evaluation Committee 2013-60 Form of Contract between a National Clinical Research Supervisor and a CRO
Related classification: Other
First published: Apr. 2014
Revised publication date: December 2021
Question
An overseas company headquartered overseas and having no business office in Japan requests CRO A, which is different from our company, to provide in-country caretaker services for a clinical trial, but CRO A does not have an organization to perform monitoring services, so CRO B, which is our company, is requested to provide monitoring services on a contract basis. In this case, is the following type of contract appropriate?
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1) Number of reports and countries from which data was obtainedRegarding in-country caretaker services for clinical trials, an outsourcing agreement should be concluded between an overseas company and CRO A, and a further outsourcing agreement for monitoring services should be concluded between CRO A and CRO B.
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2)
A contract of trust for domestic clinical trial administrator services is concluded between the overseas company and CRO A, and a contract of trust for monitoring services is concluded between CRO A and CRO B,
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(a)CRO A and CRO B conclude an outsourcing agreement for monitoring services between the overseas company and CRO B, and
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(b) The head of Medical Institution G shall conclude with the heads of Medical Institutions A through E respectively.Clarify the division of duties between CRO A and CRO B.
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In both cases 1) and 2) above, a tripartite contract should be concluded between the implementing medical institution, CRO A, and CRO B.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the contract with CRO B, which is entrusted with monitoring, whether the overseas company, which is the sponsor of the clinical trial, or CRO A, which is the domestic manager of the clinical trial, will be the contracting party will depend on the details of the contract between the overseas company and CRO A. If CRO A, as the in-country caretaker of the clinical trial, outsources (or, from the overseas company's perspective, sub-commissions) monitoring services to CRO B, then CRO A would be the contracting party. If the overseas company outsources such work to CRO B, then the overseas company becomes the contractor. However, it is important to clarify the roles of the overseas company, CRO A, and CRO B, so we recommend a three-party contract including CRO A.
With regard to the clinical trial contract with the site, Article 13, Paragraph 1, Guidance 2 of the GCP states, "Upon agreement between the party requesting the clinical trial, the contract research organization, and the site, a two-party contract between the contract research organization and the site may be acceptable. tosareteimasu。 In other words, if CRO A, CRO B, and the implementing medical institution agree, a two-party contract between CRO B and the implementing medical institution is also possible.
Reason for revision of opinion
The opinion text has been partially revised in accordance with the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020).