Drug Evaluation Committee 2008-53 Response to the Publication of Procedures, etc. of Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
Question 1
According to Article 28-3 of the GCP, "The establisher of a clinical trial review committee shall make public a summary of the ・・・・・ meeting records.
In medical institutions that outsource clinical trial review to an external Clinical Trial Review Committee, is it necessary to make the "summary of meeting records" available for review in addition to the Clinical Trial Review Committee's Procedures, etc.?
Question 2
In relation to the items that must be included in the explanatory document provided to subjects under GCP Article 51, Paragraph 1, Item 15), must it also be stated that the "summary of the meeting record" can be confirmed in addition to the clinical trial review committee's procedures, etc.?
Question 3
Although it may vary depending on the result of the above question, which of the following (1) to (3) may be actually taken at a medical institution that outsources clinical trial review to an external clinical trial review committee, and which of them corresponds to the method required by GCP?
(Excluding cases in which the investigational review committee that conducted the review discloses the results on its website)
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(1)If a subject requests disclosure of clinical trial review, it is disclosed at the Clinical Trial Review Committee as written in the explanatory document, so it is sufficient if the subject can confirm the information by going there.
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(2)Since the investigational study review procedure manual and list of committee members are already available at the time of the request for review, an agreement should be made with the establisher of the investigational study review committee so that the "summary of meeting records" can also be obtained and disclosed upon request.
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(3)The "Summary of the meeting record" should be obtained and placed at the end of each review to respond to the subject's request for disclosure.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
As stated in your question, the obligation to publicize the procedures, etc. of a clinical trial review committee lies with the establisher of the relevant clinical trial review committee. Therefore, in cases where the review is requested to an external clinical trial review committee, the medical institution is not obligated to publicize the procedure manual, etc. of the relevant clinical trial review committee.
Question 2
GCP Article 51, Paragraph 1, Guidance 4 states, "The explanatory document to be delivered to subjects of a clinical trial shall include a statement to the effect that the procedure manual, etc. of the investigational review committee can be checked..." This "procedure manual, etc. of the investigational review committee" refers to "the procedure manual, list of committee members and summary of meeting records of the investigational review committee" (GCP Article 28, Paragraph 3, Guidance 4). (See GCP Article 28, Paragraph 3, Guidance 1). Therefore, it is necessary to state in the explanatory document that the summary of the meeting record can be confirmed.
Question 3
Under the provisions of GCP, we do not see any problem if it can be handled in (1) (Disclosure at the Clinical Trial Review Committee).
However, considering the time and effort required for subjects in cases where the external review committee is located far away, it may be desirable to prepare a system that can respond to (3) after performing (2) (contracting with the establisher of the clinical trial review committee) in addition to (1), but the extent to which this should be done may depend on the judgment of the site. However, the extent to which this should be done may depend on the judgment of the site.