Drug Evaluation Committee 2020-52 Contracting Procedures for Clinical Trials for which a National Clinical Research Supervisor is Appointed
Related classification: clinical trial contracting procedures
First published: Apr. 2021
Question
We received a request for a clinical trial with the following operation.
- Sponsor Overseas pharmaceutical company → Company A
- In-country clinical trial manager Domestic affiliate of Company A → Company B
- Client's agent CRO located in Japan
The CRO has a letter of attorney regarding the execution of sponsor operations on behalf of Company A. There is no contract of commission, etc. between the CRO and Company B, and the letter of attorney from Company A clearly states that the CRO is to submit the application documents for Company B. In addition, Company B has no authority to contract.
According to Article 15 of the GCP, the procedures for a clinical trial must be carried out by a person who is not a domestic manager of the clinical trial. However, according to Article 15 of the GCP, I think that a contract is not included in the procedures related to a clinical trial.
| Signature/name and seal on the contract |
Address |
|---|---|
| Client's representative in the clinical trial |
Address |
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
With regard to the responsibilities of the in-country caretaker, Article 15 Guidance 1 of the GCP stipulates that "...the in-country caretaker shall perform all procedures related to the request for a clinical trial in Japan in accordance with the criteria for requesting a clinical trial..." and this "all procedures" includes the conclusion of a clinical trial agreement with the investigational institution based on Article 13 of the GCP (GCP Article 13). This "all procedures" includes the conclusion of a clinical trial agreement with the site under Article 13 of the GCP (Article 57 of the GCP). On the other hand, Article 13, Paragraph 1, Guidance 2 of the GCP stipulates the contractor of a clinical trial with a site, and when there is an agreement among the site, the sponsor and the contract research organization, and when operations related to the conduct of the clinical trial can be smoothly conducted at the site, a three-party contract, a bilateral contract between the site and the sponsor, a tripartite contract between the site and the sponsor, and a tripartite contract between the site and the contract research organization. Although Article 13, Paragraph 1, Guidance 2 of the GCP does not mention cases involving an NDA, based on these provisions and the concept, if there is an agreement among the four parties including the NDA, the question may be asked to the sponsor. However, in light of these provisions and the concept behind them, we believe that if there is an agreement among the four parties including the in-country clinical trial manager, a contract in the form you are asking about may be acceptable.
However, since the NAC has the responsibility as an agent of the sponsor for the stakeholders of the clinical trial, including notification of the clinical trial to the regulatory authorities and reporting of adverse drug reactions to the regulatory authorities, procedures must be established to enable the NAC to fulfill its responsibilities, including reporting and problem-solving routes. Therefore, it is a prerequisite that procedures sufficient to fulfill the responsibilities of the in-country caretaker of a clinical trial, including reporting and problem-solving routes, are established.