Drug Evaluation Committee 2014-40 Clinical Trial Review Committee Meeting Records
Related classification: Clinical Trial Review Committee
First published: Feb. 2015
Revised publication date: Mar. 2021
Question
I would like to ask a question because an audit was conducted at the site I am in charge of and I have questions about the points raised there.
Background
- The site (we will refer to it as site A) has conducted a clinical trial in the past. The clinical trial has never been conducted in the past at the relevant implementing medical institution (we will refer to it as "Implementing Medical Institution A").
- The clinical trial implementation system at site A consists of two investigators and two CRCs (both of the two investigators are clinical research coordinators). (Both of the two investigators have experience in several clinical trials, and the CRC has sufficient experience.)
- The investigator at site A has no clinical trial experience. (They are familiar with the area and have time to spare.)
- The investigator received training on GCP and SOPs from the SMO prior to conducting the trial, and there is a record of the training signed by the investigator.
Matters pointed out in the audit
- The investigator has no clinical trial experience, but there is no record of the review of the investigator's eligibility in the minutes of the initial Clinical Trial Review Committee review.
- Since there is no record in the minutes, it cannot be said that the investigator was reviewed for eligibility, which is a violation of GCP.
Question
When the request for review was made to the Clinical Trial Review Committee, the request form stated that the investigator's curriculum vitae was a review document, and the Clinical Trial Review Committee used the curriculum vitae to discuss the investigator's eligibility, but since there were no questions or answers, the minutes of the meeting did not specifically state this. Since the investigator's curriculum vitae was used as a review document (it was also recorded in the clinical trial request form), I believe that the investigator's eligibility was reviewed by the Clinical Trial Review Committee, but since it was not mentioned in the minutes, does that mean that the eligibility was not reviewed?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 2, Guidance 8 of the GCP stipulates that "the minutes of a clinical trial review committee meeting (so-called minutes) should contain not only the conclusions of deliberations (approval, disapproval, etc.) but also the names of committee members who participated in the deliberations and voting, as well as a summary of the proceedings. However, it does not specify specific items that should be included in the agenda.
The materials to be reviewed by the Clinical Trial Review Committee include the "curriculum vitae of the person to be the principal investigator, etc." (GCP Article 32, Paragraph 1, Item 4), and the materials used for this review are preserved together with the minutes in accordance with GCP Article 34. In addition, the investigational review committee submits to the head of the institution a "document in which the investigational review committee itself confirms that the investigational review committee is organized and operates in accordance with GCP" along with a notification document containing the materials used in the review and the conclusions of the review. In general, when these materials and documents are reviewed together, it can be explained that the investigator's eligibility was reviewed. If the investigator's eligibility was reviewed as a matter of fact, there should be no problem even if there is no statement such as "the investigator's eligibility was confirmed" in the minutes.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.