Drug Evaluation Committee 2013-48 External Members in the Roster of Members of Contractor Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
Date of first publication: January 2014
Question
Our hospital has an agreement with a clinical trial review committee established by another medical institution (clinic director) to which we are entrusted to review. The classification of committee members in the "Nomination and Roster of Clinical Trial Review Committee Members" available to our hospital considers the implementing medical institution to be an external clinic, and does not indicate whether or not there is a conflict of interest with our hospital.
In addition, perhaps because the director of the external clinic also serves as the chairman of the board of directors, there are cases where the director's seal is used on documents that should be issued in the director's name, and cases where the chairman of the board of directors' seal is used, as shown below.
Contract for entrustment of a clinical trial review committee: Director's seal
Nomination form and list of Chairpersons: Director's seal and Chairman's seal
Question 1
Is it necessary to obtain a "Nomination Form and Roster of Members of the Clinical Trial Review Committee" that specifies our hospital as the site of the study and the committee member categories that indicate whether or not they have an interest in our hospital?
Question 2
Is it necessary to unify documents in the name of the director of the external clinic with the director's seal?
JPMA's Opinion
Question 1
Since Article 28, Paragraph 3, Guidance 4 of the GCP states that "the list of members of a clinical trial review committee shall include their occupation, qualifications and affiliation," we believe that it is possible to determine from the list of members whether or not "a person who has no interest in the implementing medical institution (your hospital)" has been added to the list. Therefore, we do not think it is necessary to issue a separate list that includes "the classification of committee members that indicates whether or not they have an interest in your hospital.
Question 2
If a clinical trial review committee established by another medical institution is to be asked to conduct investigations and deliberations, an agreement must be concluded in advance between the Chairperson of the medical institution and the head of the medical institution that established the clinical trial review committee. In addition, the head of the medical institution who establishes the clinical trial review committee is responsible for appointing the committee members. On the other hand, GCP does not permit a medical corporation (e.g., Chairperson) to establish a clinical trial review committee (see Opinion 2007-04). Since the seal is an action that indicates who made the decision and in which capacity, it is necessary to use a seal that indicates the correct position (Director) when stamping the documents in question in order to avoid misunderstandings from third parties.