Drug Evaluation Committee 2013-34 Change of the representative of the establishment in the Joint Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: November 2013
Question
Background of the Clinical Trial Review Committee
Clinical Trial Review Committee jointly established by the presidents of three hospitals (A, B, and C)
SOP stipulates that the director of Hospital A as the representative of the establishment shall be responsible for contracts, etc. for contracted review by the said committee.
The specific contracts in which the name of the representative of the establishment was used are as follows
- Contract for entrustment of clinical trial review (a comprehensive contract, not a case-by-case contract), and
- Memorandum of understanding on clinical trial review costs (contract for each clinical trial project), etc., with Hospital A (representative of the establishment).
- Hospital A (the representative of the establisher) concludes with the implementing medical institution and the sponsor of the clinical trial.
Question
If the representative of the three hospitals is changed from Hospital A to Hospital B (revision of the SOP), how will the contracts and other documents be handled? Will the contracts concluded in the past become invalid, and will we need to re-sign with the representative installer after the change? Or is it possible to notify the customer of a "Notice of Change of Representative Installer" or the like, and then readjust the contract? Please let us know if there are any other matters to be noted in relation to the above changes other than those related to contracts.
JPMA's opinion
It is stipulated that the Chairperson of the site and the establisher of the Investigational Review Committee must conclude an agreement in accordance with Article 30, Paragraph 2 of the GCP.
The investigational review committee in the case in question falls under the category of an investigational review committee jointly established by the heads of multiple medical institutions as stipulated in Article 27, Paragraph 1, Item 1 of the GCP, but because the investigational review committee itself is not changed and the representative person who established it is changed, the contract between the head of the implementing medical institution and the establisher of the investigational review committee does not lose its validity. However, the contract between the head of the institution and the establisher of the investigational review committee will not lose its validity. There is no problem in notifying the medical institution and the sponsor of the clinical trial of the change in the representative of the establishment.
Please note that if the name of the representative of the establishment is written in the procedure manual and related forms, etc. of the relevant clinical trial review committee, these should also be revised.