Drug Evaluation Committee 2007-06 Clinical Trial Agreement when CRO is Involved from the Start of Clinical Trial Implementation
Related classification: clinical trial contracting procedures
First published: August 2007
Revised publication date: Mar. 2021
Question
Currently, a clinical trial is being conducted under a two-company contract between a medical institution and a sponsor, but the sponsor has decided to outsource the work to a CRO in the middle of the trial.
From now on, the clinical trial will be conducted by three companies in effect, but what should the contract be like? Should we add a memorandum of understanding to the current two-company contract to make it three companies, or should we dissolve the two-company contract and have a new three-company contract concluded?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When the sponsor outsources a part of the work and the contracted contract research organization (CRO) performs the work at the site, the contract for the clinical trial under Article 13, Paragraph 1 of the GCP must be concluded in writing between the sponsor, site, and contract research organization (CRO). The contract must be concluded in writing between the sponsor, the site and the contract research organization (CRO).
Article 13, Paragraph 1, Guidance 2 of GCP states "When operations related to preparation and management of a clinical trial by a person who intends to request a clinical trial and operations related to implementation of a clinical trial at a medical institution can be smoothly implemented, a contract shall be concluded between the person who intends to request a clinical trial and the medical institution, and between the person who intends to request a clinical trial and the (2) In the case where the clinical trial can be smoothly conducted, it is acceptable to conclude an appropriate contract in writing between the party who intends to request the clinical trial and the site, and between the party who intends to request the clinical trial and the contract research organization. It is also acceptable to make it a bilateral contract between the contract research organization and the contract research organization upon agreement among the person who intends to request the clinical trial, the contract research organization, and the contract research organization. The law also states that "a contract between a contracting organization and an implementing medical institution is acceptable. There is no particular provision in GCP regarding the form of contract in the case of outsourcing to a CRO in the middle of a clinical trial, and there is no problem with any of the following.
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New three-party contract
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A memorandum of understanding to the effect that a two-party contract is to become a three-party contract
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A memorandum of understanding to the effect that CRO outsourcing is added to the two-party contract together with the contract between the sponsor and the CRO.
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A memorandum of understanding is concluded between the three parties to the effect that the contractor is changed from the sponsor to the CRO, and any subsequent changes to the contract are handled in a bilateral memorandum of understanding between the CRO and the site.
When using a memorandum of understanding, it is necessary to specify the scope of work entrusted to the CRO by the sponsor and to replace "the sponsor (e.g., B)" in the original contract with "the sponsor (e.g., B) and the contract research organization (e.g., C). In this case, please note that "B" may be changed to "B and C" or "B" may remain the same, depending on the terms of the original agreement.
In addition, when concluding a new tripartite agreement with a CRO in addition to the original two-party agreement, there are also matters to be noted. In order to clarify the history up to that point, the former agreement should be preserved. Care must also be taken to ensure that there is no gap in the contract period between the two-party contract and the three-party contract.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor improvements have been made to the description.