Drug Evaluation Committee 2009-26 Procedures for changing a clinical trial contract due to a change in CRO
Related classification: clinical trial contracting procedures
Initial release date: January 2010
Revised publication date: March 2021
Question
We have a three-way contract with a sponsor, a CRO, and our hospital for a clinical trial that will last until next April. Recently, the CRO informed us that the contract with the sponsor will expire in December of this year, and that another CRO will take over the contract without extending it. They also said that they would like to continue monitoring for the period they have been in charge after the contract ends.
In this case, what should the contract be like?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since the details of the contract between the sponsor and the CRO are unknown, I will answer from a general perspective.
The CRO will be involved in the clinical trial under an outsourcing contract with the sponsor based on Article 12 of the GCP. Furthermore, when another CRO (hereinafter referred to as "new CRO") is to conduct the relevant clinical trial at the site after December, a contract must be concluded in writing between your hospital, the sponsor, and the new CRO. If the work related to the preparation and management of the clinical trial by the sponsor and the implementation of the clinical trial at the site can be carried out smoothly, it is acceptable to conclude an appropriate contract in writing between your hospital and the sponsor, and between the sponsor and the new CRO. If the operations related to the implementation of a clinical trial at a medical institution can be conducted smoothly, it is acceptable to conclude appropriate agreements in writing between your hospital and the sponsor and between the sponsor and the new CRO. It is also acceptable for your hospital, the sponsor, and the new CRO to enter into a bilateral agreement between your hospital and the new CRO upon agreement by the three parties (GCP Article 13, Paragraph 1, Guidance 2).
Please note that once the contract with the CRO that has been conducting the work up to this point (hereinafter referred to as the "old CRO") is terminated, the new CRO will no longer be the CRO for the clinical trial in question and will not be able to conduct monitoring. If the former CRO continues to perform monitoring after December, the contract between the sponsor and the former CRO should be extended, and the clinical trial agreement should clarify the division of duties between the former and new CROs and the period of overlapping monitoring. First, please discuss with the sponsor the necessity of monitoring by the old CRO.
Reason for revision of opinion
In accordance with the revision of the GCP Guidance (August 31, 2020), we have changed the explanations in the relevant sections.