Drug Evaluation Committee 2010-51 Agreement on Commissioning of Review by Clinical Trial Review Committee (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: Apr. 2011
Question
When outsourcing the review of a clinical trial review committee, an agreement between the head of the medical institution and the establisher of the clinical trial review committee is required, but can the agreement be comprehensive? Is it possible to make the contract comprehensive or must it be concluded for each clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 27, Paragraph 1, Guidance 2 states, "The head of the implementing medical institution shall establish the procedures necessary for selecting an appropriate investigational review committee, and shall select an investigational review committee that has sufficient personnel to conduct investigations and deliberations, and is capable of deliberating and evaluating from ethical, scientific, and medical/pharmacological perspectives, for each clinical trial. The regulations stipulate that "an appropriate committee shall be selected for each clinical trial, and a request for investigation and deliberation shall be made to the committee. The regulation stipulates that "a clinical trial review committee that is capable of deliberation and evaluation from scientific, ethical, scientific and medical/pharmacological perspectives shall be appropriately selected for each clinical trial and requested to conduct investigations and deliberations. On the other hand, Article 30, Paragraph 2 of the GCP requires the conclusion of a contract when requesting investigation and deliberation, but does not specify the form of the contract.
Therefore, as long as an appropriate investigational review committee can be selected for each clinical trial and a request for investigation and deliberation can be made, either a comprehensive contract or a contract for each clinical trial is acceptable. In other words, even if a comprehensive contract is concluded, it should be noted that the head of the site must select the appropriate investigational review committee for each clinical trial in accordance with the established procedures to determine whether the request for investigation and deliberation by the investigational review committee is appropriate for that clinical trial. Furthermore, as stated in Article 30, Paragraph 2, Guidance 4 of the GCP, it is necessary to set a time limit for the investigational review committee to give its opinion in accordance with the characteristics of the clinical trial, so in the case of a comprehensive agreement, it is necessary to confirm for each clinical trial whether the time limit is appropriate.