Drug Evaluation Committee 2011-35 Permission to substitute minutes for meeting summaries of Clinical Trial Review Committee meetings for public release
Related classification: Clinical Trial Review Committee
Date of first publication: Apr. 2012
Question
I believe that the 2008 Revised GCP Ministerial Ordinance stipulates the publication of summaries of clinical trial review committee meeting records, etc. The ordinance states, "It is desirable to publish the minutes of clinical trial review committee meetings on the website of the site, but if the site does not have a system in place, the minutes may be made available for public inspection by being kept at the site office, etc. However, in cases where no such system is in place, it is acceptable to make the information available to the public by keeping it in an office, etc.".
Our hospital has a website, but we do not have a system in place to publish summaries of meeting minutes, etc. (there is no staff in the hospital who can regularly update the website), so we keep them in writing at the Clinical Trial Office.
When we asked a pharmaceutical company about the necessity of preparing a summary of the meeting minutes, etc., as stipulated in the GCP, because we cannot publish them on our website, the company replied, "As long as the items required for publication are covered in the minutes, there is no need to prepare a separate summary of the meeting minutes, and there is no problem by replacing the minutes with the summary of the meeting minutes. If there is a request for access to the minutes, we will ask other pharmaceutical companies to provide a copy of the minutes. If there is a request for access to the minutes, the minutes of other sponsor's clinical trials are published with necessary measures such as masking.
However, the sponsor of a clinical trial that has recently started said, "Minutes are minutes and summaries are summaries, so even if all the necessary items are covered in the minutes, a summary of the meeting record needs to be prepared. We would like the summary of the meeting record to be kept on file along with the minutes. I explained that I had not prepared a summary because we did not have a system in place to publish it on our website, and also because I had been told that there would be no problem with replacing the summary with the minutes.
Is it "minutes are minutes and a summary is a summary," or is it "if the content is covered, we don't have a publication system in place.
If there are necessary items in the minutes, there is no problem to read them over"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you mentioned in your question, if the "summary of meeting records" contains the necessary items in the "minutes," there should be no problem with replacing the "minutes" with the "summary of meeting records.
As stipulated in Article 28, Paragraph 3, Guidance 3 of the GCP, the "summary of the record of meetings" of the clinical trial review committee must be available for public inspection through the website of the implementing medical institution, etc. or by being kept in the office. In addition, when the public is allowed to inspect the documents, any content that infringes on the sponsor's intellectual property rights must be disclosed after taking measures such as masking (GCP Article 28, Paragraph 3, Guidance 5). For this reason, it is common practice to prepare a "summary of the meeting record" for public inspection and keep it at the office so that it can be presented promptly upon request for public inspection, always masking the necessary items. Since the "minutes" are expected to contain more information than the "summary of the meeting record," it is necessary to ensure that the predetermined portions are masked at the time of the request for inspection before making them available for public inspection. In addition, it is recommended that this be documented as a common procedure for the relevant Clinical Trial Review Committee (e.g., in the Clinical Trial Review Committee's procedure manual) so that the sponsor is also aware of this.