Drug Evaluation Committee (9) Clinical Trial Protocol and Record of Designation of Monitors
Related classification: Clinical trial contract procedures
First published: December 2004
Revised publication date: December 2021
Question
Is it acceptable for monitors who are not listed in the study protocol to conduct monitoring? If so, what is the significance of including monitors in the protocol?
JPMA's Opinion
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
We have made minor changes to the descriptions in accordance with the issuance of GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).