Drug Evaluation Committee 2011-43 Clinical Trial Protocol, Volume 2, Necessity of Providing a List of Monitors
Related classification: Other
First published: Apr. 2012
Revised publication date: December 2021
Question
The list of investigators, sites, and monitors can now be divided into separate volumes, and the Clinical Trial Review Committee does not need to review any changes other than those related to the investigator's own hospital if the volume is divided. When we checked whether or not the list of monitors had been separated in the clinical trials currently in operation, we found that some of them had not submitted the list of monitors. When we checked with the sponsor, they replied that they could not provide the list to the site. Is the submission of the list of monitors (only those related to the relevant medical institution) not required under GCP? If it is not required, is it correct to say that submission is not necessary and that even if the monitor in charge of our hospital changes, there is no need for review by the Clinical Trial Review Committee?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As per GCP Article 7, Paragraph 1, Guidance 2, "The specific items that should normally be included in the investigational protocol (including the revised version) are as follows. In addition, the guidance in Article 7, Paragraph 1, Guidance 2 of the GCP states that "For specific items that should normally be included in the clinical trial protocol (including the revised version), refer to Report 10 of the Central Pharmaceutical Affairs Council as appropriate". The guidance also stipulates the handling of the names of monitors in charge of each site.
This guidance revises the names of the monitors to be listed in the clinical trial protocol and its subparts to "the names of the monitors in charge of the site (or the representative if there are multiple monitors) and ...," so that normally only the representative is required to be listed, and the list of monitors in charge of the site is not required to be listed in the clinical trial protocol or its subparts. Therefore, it is not necessary to prepare and submit the list of monitors in charge of the relevant investigational sites as the clinical trial protocol or a separate volume of the protocol. However, if a person who is not a monitor (or a representative if there is more than one monitor) listed in the protocol or its volume is to inspect the medical record, the name of the monitor must be made available to the medical institution in some way (GCP Article 7, Paragraph 1, Guidance 3).
As stated in the past opinions (2009-12 and 2009-27), the change of monitors does not require the review of the Clinical Trial Review Committee.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).