Drug Evaluation Committee 2008-52 Scope of Information to be Included in the Summary of Clinical Trial Review Committee Meeting Records
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
On February 5, 2009, the Drugs and Foods Administration Bureau issued a "Q&A on Periodic Reporting of Adverse Reactions to Clinical Trials and Preparation of Summaries of Clinical Trial Review Committee Meeting Records" in the form of an administrative communication, and we have received the following questions from many sponsors of clinical trials.
- I would like to have a summary of the minutes of the pre-publication meeting confirmed each time before publication.
- Is it possible to mask the outline of the minutes before publication after confirmation by the sponsor?
- After publication, how can we ask the sponsor to reconfirm that the summary of the minutes confirmed by the sponsor is as per the indicated masking? (in person, by PDF, or by fax)
In accordance with the February 5, 2009, Office Communication, we intend to conduct the trial as described above in the examples, but do we have to respond to each sponsor's confirmation of the summary of the proceedings individually?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 28, Paragraph 3, Guidance 5 states that "If the establisher of a clinical trial review committee receives a request from a sponsor, etc. to confirm in advance whether the summary of the meeting record contains any content that infringes the intellectual property rights of the sponsor, etc., the investigator shall comply with the request and, if necessary, take measures such as masking the record and make it public. If necessary, the investigator shall take measures such as masking the information and disclose it to the public. Therefore, if there is a request from the sponsor, it is necessary to take measures such as presenting a summary of the meeting record to be released in advance and masking the contents that infringe on intellectual property rights. However, if the summary of the meeting record is prepared in accordance with the attachment (Model Summary of Clinical Trial Review Committee Meeting Record) to the administrative communication mentioned in your question, it should not infringe on the sponsor's intellectual property rights in general. It is considered that an explanation to the sponsor in advance that the summary of the meeting record will be prepared in accordance with the above-mentioned administrative communication will be understood by the sponsor. Even in this case, some trial sponsors may request confirmation before publication, and we would appreciate their cooperation.
In this case, we would appreciate your cooperation. If the sponsor is informed of the timing of publication in advance, it will facilitate the confirmation by the sponsor.