Drug Evaluation Committee 2009-27 Positioning of "Reporting" in Clinical Trial Review Committee (Part 2)
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
We would like to ask your opinion on the position of "Reporting" in a Clinical Trial Review Committee.
Question 1
According to Article 28 of the GCP, the mission of a clinical trial review committee is to deliberate and evaluate a clinical trial from ethical and scientific perspectives (ethical, scientific and medical/pharmacological). Administrative matters (e.g., changes in the organization or structure of the sponsor, changes in the name or department of the medical institution, changes in the location or telephone number of the medical institution or sponsor, changes in the title of the principal investigator, changes in monitors) are not considered appropriate items for the Trial Review Committee to discuss and evaluate from an ethical and scientific perspective. What do you think?
Question 2
In your opinion on question No. 2009-12, it is stated that the review method of "report" is not indicated in the GCP ordinance, and I think you are right. I think you are right. "Report" is different from "review".
In GCP Article 28, Paragraph 2, Operational Notification 2 (3) <4>, it is stated that when an expedited review is conducted, a "report" is made to the next meeting of the Clinical Trial Review Committee. Similarly, when the secretariat of a clinical trial review committee obtains the latest documents from the site regarding changes in administrative matters, from the perspective of ensuring that the members of the clinical trial review committee are aware of the changes, would it be appropriate to "report" such changes at the clinical trial review committee meeting?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
GCP Article 28, Paragraph 2, Guidance 2 (3) <4> states, "With regard to minor changes to an ongoing clinical trial that has already been approved by the Clinical Trial Review Committee, the conditions for expedited review and approval (scope of expedited review, who makes decisions, review methods, reports to the next meeting of the Clinical Trial Review Committee, etc.) shall be established. " It is stated as follows. As stipulated in Article 31, Paragraph 2, Guidance 3 of GCP, "Changes that affect the conduct of the clinical trial, may cause mental or physical harm to the subject, or increase the risk to the subject" should be subject to the opinion of the Clinical Trial Review Committee. The guidance states that the opinion of the Clinical Trial Review Committee should be obtained for "changes that affect the conduct of the clinical trial, may cause mental or physical harm to subjects, or increase the risk to subjects. However, if the head of the site determines that it is necessary to hear the opinion of the Investigational Review Committee in light of Articles 28 and 31 of the GCP, the Investigational Review Committee will conduct a review of the change. The clinical trial review committee will be charged with the responsibility of reviewing the clinical trial.
Question 2
Considering the responsibilities placed on the investigational review committee, if the head of the site determines that there is no need to hear the opinions of the investigational review committee, there is no need to report to the committee members regarding the change in the relevant administrative matters.