Drug Evaluation Committee 2009-24 Preparation of Clinical Trial Review Committee Minutes by IRB Office Staff Who Also Serve as Clinical Research Collaborators (CRCs)
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
Is it a violation of GCP for an SMO CRC to attend an investigational review board (IRB) meeting as a clinical research coordinator and take minutes? This CRC is registered as a clinical trial coordinator on the investigator list.
Background
The resident SMO to which the CRC belongs has a clinical trial support agreement with the hospital director. The details of the agreement are as follows
Scope of SMO's duties
At the request of the hospital, the SMO performs clerical support for the following tasks related to the implementation of the clinical trial
- Establishment and operation of the clinical trial office
- Duties related to the implementation of clinical trials
- Duties related to IRB
- Duties related to management of investigational new drugs
- Explanation to subjects about the clinical trial and obtaining their consent
- Duties related to the implementation of clinical trials (clinical tests, observation, etc.)
- Monitoring and auditing by the sponsor and cooperation in investigations by IRB and regulatory authorities
- Preparation of case reports
- Reporting of adverse events during a clinical trial
- Other tasks necessary for the conduct of the clinical trial
The CRC supports the investigator's work under the supervision of the investigator based on the above contract, and supports the clinical trial secretariat and IRB secretariat work as a clinical trial secretariat member under the supervision of the hospital director.
According to GCP, investigators are not allowed to participate in IRB deliberations and voting, but it does not state that they must leave the IRB after attending a meeting to explain the trial. In reality, it may be difficult to operate an IRB in compliance with GCP in many cases if a CRC does not participate.
Question 1
We do not see a problem with CRCs attending as IRB clerical staff, since they are on the list of investigative collaborators but do not participate in the deliberations and voting. What do you think?
Question 2
Is it possible for an internal CRC whose name is on the list of clinical trial collaborators to attend IRB meetings and take minutes?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 4 of the GCP stipulates the appointment of a person to perform the duties of the investigational review committee, but it does not specify the responsibilities and positions of the person who is to serve as the person in charge. In addition, Article 29, Paragraph 1 of the GCP stipulates that a cooperative investigator may not participate in the deliberation and voting on a clinical trial subject to review, but there is no provision prohibiting a cooperative investigator from attending a clinical trial review committee as a secretariat and taking minutes of the proceedings. Furthermore, although there is no specific provision in GCP, the minutes of a clinical trial review committee meeting are usually considered to be fixed by the approval of the chairperson and committee members.
Therefore, we do not think there is any problem under GCP for an investigator who also serves as the secretariat of a clinical trial to attend a clinical trial review committee meeting as the secretariat of a clinical trial and prepare draft minutes.