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
The Investigator Site I am in charge of has been audited, and I have some questions about the remarks I received there.
Background
- The Investigator Site (we will refer to it as "Investigator Site A") (We will assume that the investigational study has never been conducted at the site (site A) in the past.
- Investigator Site A has a clinical trial implementation system with 2 investigators and 2 CRCs. (Both of the two investigators have experience in several clinical trials, and the CRC has sufficient experience.)
- The investigator at Investigator 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?
JPMA's Opinion
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 the specific items that should be included in the agenda.
The materials used for review by the Clinical Trial Review Committee include the "curriculum vitae of the person to be the principal investigator" (GCP Article 32, Paragraph 1, Item 4), and these materials are stored with the minutes of the meeting based on GCP Article 34. In addition, a "document in which the Investigator Site's Clinical Trial Review Committee confirms that the committee is organized and operates in accordance with GCP" is submitted by the committee to the Investigator Site Chairperson, 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 viewed 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
We have made minor changes to the descriptions in accordance with the issuance of GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).