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) for entrusted review. The committee member classifications in the "Investigator Site Nomination Form and Roster of Members of the Clinical Trial Review Committee," which is available to our hospital, consider the Investigator Site to be an external clinic, and do not indicate whether or not they have any vested interest in 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 the "Nomination Form and Roster of Members of the Investigator Site Committee," which specifies the categories of the committee members indicating 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 the investigational review committee shall include their occupation, qualifications, and affiliation," we believe that it is possible to determine whether or not "persons who have no interest in the Investigator Site (your hospital)" are added to the list of members. 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 Investigator Site's Chairperson and the Chairperson of the medical institution that established the relevant 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.