Drug Evaluation Committee 2017-03 Scope of Responsibility of Monitors
Related classification: Other
Initial publication date: June 2017
Revised publication date: Mar 2021
Question
In clinical trials where risk-based monitoirng is being conducted, due to the limited number of visits Is the sponsor not directly responsible for providing explanations?
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1.Agreeing on revisions to the study protocol, investigational new drug summary, etc. by mail
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2.Explanation to staff regarding 1. is conducted by the investigator and a record is kept
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor is supposed to provide the investigator with the latest investigational new drug summary or documents describing scientific findings and other necessary materials and information, such as the draft study protocol (GCP Article 7, Paragraph 4/5 Guidance 1). In addition, the investigator is to provide sufficient information, guidance and supervision of the investigator, subinvestigators and collaborators regarding the protocol, the investigational drug and their respective duties (GCP Article 43, Paragraph 2, Guidance 1).
GCP does not stipulate that the sponsor must directly explain the revision of the protocol or drug profile. On the other hand, monitors are required to play a leading role in the exchange of information between the sponsor, investigator, and site, etc., and to confirm that the site director, investigator, subinvestigator, collaborator, and investigational drug manager are fully informed about the clinical trial (GCP Article 21, Paragraph 1 Guidance 9 (1) and (7)). Therefore, monitors need to carefully judge how to provide appropriate information to investigators based on the revised protocol. In addition, the method of informing staff other than the investigator should also be discussed with the investigator based on the revised content.
In the case of your question, we do not know how the sponsor conducts "risk-based monitoring," but we believe that the fact that the number of visits is limited is not a reason for the monitors not to explain the revisions directly to the investigators. I am not sure how the "monitoring" is implemented.
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.