Drug Evaluation Committee (9) Clinical Trial Protocol and Record of Designation of Monitors
Related classification: clinical trial contracting procedures
First published: December 2004
Revised publication date: December 2021
Question
Is it acceptable for a monitor who is not listed in the study protocol to conduct monitoring? If so, what is the significance of including monitors in the protocol?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The names and telephone numbers of monitors (or their representatives if there are multiple monitors) may be listed in a separate volume of the protocol, and only those pertaining to each site concerned need to be submitted. If the names, etc. of the monitors are not listed in the separate volume during monitoring with direct inspection, it is necessary for the site to be able to identify the names, etc. of the relevant monitors.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.