Drug Evaluation Committee 2012-53 Issuance of Notification of Clinical Trial Results upon Review of a Clinical Trial by a Clinical Trial Review Committee for a Physician in Charge of the Trial
Related classification: Clinical Trial Review Committee
First published: May 2013
Revised publication date: December 2021
Question
Article 43, Paragraph 1, Guidance 1 of the GCP states that "Although it is acceptable to assign a physician to a clinical trial from the time of approval by the Chairperson of the site, a review by the investigational review committee is required for a physician who is to be assigned to the clinical trial. However, a review by a clinical trial review committee is required for the investigators who are to be assigned to the clinical trial. Is it interpreted that the issuance of a notification of the results of the clinical trial review is mandatory for this "review"?
Or, is it possible for the sponsor and the investigational site to agree on the following A to C?
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Response A
- Prepare an "Application for Change of Clinical Trial
- Obtain "Notification of Clinical Trial Review Results
- Obtain "List of Part-time Investigators and Clinical Research Collaborators
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Response B
- IRB will review the "List of Part-time Investigators/Cooperators" as a reference material.
- Obtain "Notification of Clinical Trial Review Results
- No need to issue "Application for Change of Clinical Trial
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Response C
- IRB will review the "List of Part-time Investigators/Cooperators" as a reference material.
- Record "Approved after IRB review" in the IRB minutes
- It is not necessary to obtain the "Notification of Clinical Trial Review Results". The monitor can confirm that the latest investigator information has been reviewed by the IRB through periodic review of the IRB minutes.
However, if the wording of Article 43, Paragraph 1 is strictly interpreted, then various documents and IRB review procedures will be required even if "one or more investigators are deleted".
JPMA's Opinion
The investigational review committee must notify the Chairperson of the results of the review (GCP Article 32, Paragraphs 1 and 3), and the Chairperson must notify the sponsor and investigator of his/her instructions and decision based on the opinion of the investigational review committee in writing (GCP Article 32, Paragraph 6). In addition, the eligibility of the investigator is subject to review by the investigator review committee (GCP Article 32, Paragraph 1/Section 2, Guidance 5). Therefore, the Notification of Clinical Trial Review Results is also required for the subinvestigators, and when a new subinvestigator joins during a clinical trial, it is necessary to obtain the Notification of Clinical Trial Review Results after submitting an application for change regarding the clinical trial.
In the case of removal of a subinvestigator that affects the clinical trial implementation system, a review by the Clinical Trial Review Committee is also required (GCP Article 43, Paragraph 1, Guidance 1).
Reason for revision
The opinion text has been partially changed in accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Council of Japan, No. 0730-3).