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, Investigator Site, and monitors can now be divided into separate volumes, and the Clinical Trial Review Committee does not need to review any changes except those related to the investigator's own hospital if the list is divided into separate volumes. When we checked whether or not the list of monitors in the clinical trial currently in operation had been divided into separate volumes, we found that there were places where the list of monitors had not been submitted. When we checked with the sponsor, they replied that they could not provide it to Investigator 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 a review by the Clinical Trial Review Committee?
JPMA's Opinion
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 Investigator Site.
The Guidance revises the names, etc. of monitors to be listed in the protocol as "the names of the monitors in charge of the Investigator 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 relevant Investigator Site should be listed in the clinical trial protocol or its sub-books. Therefore, it is not necessary to prepare and submit the list of monitors in charge of the relevant investigational sites as a clinical trial protocol or a separate volume of the clinical trial protocol. However, if a person who is not a monitor (or a representative if there are multiple monitors) listed in the study protocol or its volume (Article 7, Paragraph 1, Guidance 3 of GCP) inspects medical records, the Investigator Site must be able to identify the name of the monitor in some way (Article 7, Paragraph 1, Guidance 3 of GCP).
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
We have partially changed the opinion text in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).