Drug Evaluation Committee 2009-02 Confirmation of Clinical Trial Completion by Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
I am in charge of the secretariat of the IRB, which is operating only one case, and will soon be submitting a report on the completion (discontinuation or suspension) of a clinical trial. When a clinical trial termination (discontinuation or suspension) report is submitted by the head of the site to the IRB chairperson, it is often reported to the IRB members at the most recent meeting of the main review.
I believe the following methods are possible, but I would like to know your opinion on whether or not the following (1) through (3) should be taken. Please let us know if there is any other way to handle the situation.
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Although there is no plan to hold a meeting in the near future, there is a possibility that a meeting will be held in 2-3 months, and the end of the clinical trial will be reported at the main review. In this case, how many months after the submission of the termination report can we report the termination to the IRB?
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Since there are no other matters to be discussed and there is no recent IRB main review, the IRB member is called for the termination report.
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Since there are no other matters for discussion and there is no recent IRB main review, we report the completion of the clinical trial to each IRB member by letter, etc., and each IRB member replies in writing that he/she has confirmed the completion report.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When the investigator reports the termination of a clinical trial, the head of the site must notify the investigational review committee and the sponsor of the termination of the clinical trial and a summary of the results in accordance with Article 40, Paragraph 4 of the GCP. Of these, notification to the Clinical Trial Review Committee is not subject to deliberation under GCP. Therefore, the handling of the submitted termination notification documents, etc., should be in accordance with the procedures of the Clinical Trial Review Committee.
However, if there is no procedure stipulated in the procedure manual for cases such as the one in question, there should be no problem if the chairperson of the investigational review committee selects the method (1) or (3), etc., after considering the details of the termination of the results of this clinical trial. If such a case is expected to occur in the future, we recommend that it be stipulated in the procedure manual.