Drug Evaluation Committee 2010-12 Positioning of "Reporting" in Clinical Trial Review Committee (Part 3)
Related classification: Clinical Trial Review Committee
First published: Jun 2010
Question
Regarding the "Position of 'Reporting' in a Clinical Trial Review Committee," there have been Q&A ( 2009-12, 2009-27 ) in the past, but the statement "There are two review methods, meeting review and expedited review, but 'reporting' is not indicated in the GCP Ministerial Ordinance. Which of the following is the above statement?
- The only review methods are meeting review and expedited review, and there is no "report" method of review
- Reporting is not indicated as a review method, but it does not mean that it is prohibited.
At the Clinical Trial Review Committee that we are currently handling, revisions to the Appendix of the protocol and changes to the top page of the website for recruiting subjects are minor changes, such as adding or deleting additional sites or monitors, or changing the design of the page. Therefore, we do not discuss these changes, but instead "report" them to the members of the Clinical Trial Review Committee by saying, "Please confirm that the changes have been made in this way.
Our view is that the latter "reporting is not indicated as a review method, but it does not mean that it should not be done"; is this wrong?
If the opinion is the former, and in response to past Opinion 2009-27, "If the head of the site determines that there is no need to hear the opinion of the Clinical Trial Review Committee, there is no need to report to the committee members about the change in the relevant administrative matters." So, does this mean that there is no "report" at the Clinical Trial Review Committee and all minor changes will be handled through expedited review?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 32, Paragraph 1 of the GCP, "When asked for its opinion by the head of the implementing medical institution, the investigational review committee shall review whether the clinical trial under review is ethically and scientifically appropriate and whether the said clinical trial is appropriate to be conducted at the said implementing medical institution, based on the data and shall state its opinion in writing. The committee is responsible for "reviewing the materials and giving its opinion in writing as to whether or not the clinical trial to be reviewed is ethically and scientifically appropriate and whether or not it is appropriate to be conducted at the institution.
Therefore, if the head of the site judges that there is no need to hear the opinion of the committee on minor changes such as the one in your question, there is no need to "report" the matter to the committee, and the secretariat of the committee should simply keep records to understand these changes.
From the viewpoint of streamlining the work of the Clinical Trial Review Committee, we do not think it is necessarily necessary to use the method of "reporting" to inform the members of the Clinical Trial Review Committee of clerical matters.