Drug Evaluation Committee 2009-12 Positioning of "Report" in a Clinical Trial Review Committee (Part 1)
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
A clinical trial site where an SMO supports the clinical trial secretariat and CRC services has been conducting an expedited review of minor changes since the initial procedure. In April 2009, the SOP was revised at these institutions, and in addition to the expedited review items, a committee report item was added. The contents are as follows.
The clinical trial review committee reports on administrative changes related to an ongoing clinical trial that has already been approved (changes in the sponsor's organization or system, changes in the name of the medical institution or department, changes in the investigator's position, changes in monitors, etc.) or corrections to typographical errors in the protocol (except when the corrections affect the conduct of the clinical trial). (2) The following matters may be handled as matters to be reported at the Clinical Trial Review Committee meeting. However, even if it is a reportable matter, this does not apply when the Director requests investigation and deliberation (when a Request for Investigational Review is submitted) or when the Chair determines that investigation and deliberation are necessary.
When I inquired the reason for the revision of this SOP to the SMO (the person in charge of the secretariat), he replied that Article 28.2.2(7)<2> (see the article below) of the GCP operation notice is the basis for the permissible reporting response at the IRB.
The regulations should require that deviations or changes from the study protocol not be initiated prior to obtaining written approval from the investigational review committee, except when medically unavoidable, such as to avoid an immediate risk to subjects, or when the change is related to administrative matters (e.g., abbreviated).
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1.I don't think the content of Article 28.2.2 (7) <2> of the GCP operation notice is the part that stipulates IRB review and reporting, but is it the basis for what the SMO says is acceptable reporting response?
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2.I was aware that IRB reporting does not exist in GCP, but is there any problem with reporting?
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3.If the hospital's response is that a review is not required for minor changes (changes that do not affect subjects), what actions should we take as monitors?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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1.Article 28, Paragraph 2, Guidance 2 (7) <2> of GCP stipulates the contents of the procedure manual to be prepared by the establisher of the Investigational Review Board (hereinafter referred to as "IRB"), and it is not allowed to start a clinical trial before the IRB review gives an approval document except when it is medically unavoidable to avoid an urgent risk or the change is an administrative change. The IRB is required to establish a rule that requires the investigator not to initiate deviations or changes from the investigational protocol prior to the issuance of the approval document by the IRB review, unless the deviation or change is medically unavoidable to avoid immediate hazards or is an administrative change. In other words, it does not stipulate the scope of IRB review that is not required or the method of review, and cannot be used as a basis for accepting reporting.
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2.The contents of IRB review at the request of the head of the site are roughly divided into two categories: "appropriateness of conducting the clinical trial" (GCP Article 30) and "appropriateness of continuing the clinical trial ("continuing review")" (GCP Article 31). There are two types of review methods: meeting review and expedited review, but the "report" review method is not indicated in GCP.
The head of the site must keep the documents subject to IRB review up-to-date throughout the clinical trial period, and the latest documents submitted by the sponsor must also be submitted to the IRB. At this time, if the content of the latest document falls under Article 31 of the GCP, or if the content falls under "other cases deemed necessary by the head of the site," as stipulated in Paragraph 2 of Article 31 of the GCP, the IRB must conduct a continuing review. On the other hand, there may be cases where the head of the site only submits the latest documents to the IRB at the discretion of the head of the site in response to the submission of the latest documents related to administrative changes from the sponsor, as in your question. -
3.The content of the continuing review is stipulated in Article 31 of the GCP. In this provision, "other cases deemed necessary by the head of the site" is defined in Article 31, Paragraph 2, Guidance 3 of the GCP as "a change that affects the conduct of the clinical trial, has the potential to be mentally or physically invasive to the subject, or increases the risk to the subject. The second paragraph of Article 2, Guidance 3, of the Article 211, states that "a change that affects the conduct of a clinical trial, may cause mental or physical harm to subjects, or may increase the risk to subjects. Therefore, the head of the site will determine the necessity of continuing review for minor changes.
If a change in a clinical trial constitutes a clerical change, it may be sufficient for the monitor to notify the site of the change (or to confirm that the site has been notified). However, in the case of a change that the sponsor thinks it would be better to obtain the opinion of the IRB from the perspective of protecting the human rights and ensuring the safety of subjects, it is necessary to confirm the decision of the head of the implementing medical institution.