Drug Evaluation Committee 2013-50 Procedures for Discontinuation of Clinical Trial by Notification from the Sponsor
Related classification: clinical trial contracting procedures
Initial release date: March 2014
Revised publication date: December 2021
Question
We have not been able to consider how to handle the case of discontinuation of a clinical trial, and how it should be stipulated in the SOP.
In the following three cases, (1) and (3) are acceptable, but in case (2), we are left with the question of whether Form 17 should be created. Is the interpretation that Form 17 does not need to be completed in case (2) based on the current unified form and GCP?
Even if the study is terminated for the sponsor's convenience, I do not feel that the investigator has a responsibility to report the GCP compliance status, safety, etc. to the IRB.
（I feel that (2) should be written as "・・・・ The investigator shall report to the hospital director the termination of the clinical trial (Form 17) and notify the subject of the termination and provide appropriate medical care".
Thank you in advance for your guidance.
(1) The clinical trial is terminated
The investigator reports the completion of the clinical trial to the hospital director (Form 17)
Hospital Director notifies IRB and sponsor (Form 17)
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As of December 2023(4) Reporting of results to subjects as necessary
(2) The clinical trial is discontinued at the discretion of the sponsor
The sponsor notifies the hospital director of discontinuation of the clinical trial (Form 18)
Hospital Director notifies IRB/Investigator (Form 18)
The investigator notifies the subject and provides appropriate medical care
(3) The clinical trial is discontinued at the discretion of the investigator
The investigator reports discontinuation of the clinical trial to the hospital director (Form 17)
Hospital Director notifies IRB and sponsor (Form 17)
The investigator notifies the subject and provides appropriate medical care
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When a clinical trial is suspended or discontinued at the discretion of the sponsor, the sponsor must promptly notify to that effect and the details of the reason in writing to the heads of all the sites involved in the clinical trial (GCP Article 24, Paragraph 2). Furthermore, the head of the site receiving the notification must notify the investigator and the investigator review committee in writing (GCP Article 40, Paragraph 2).
GCP does not stipulate that the investigator who receives such notification must report to the head of the site the outline of the clinical trial up to its interruption or discontinuation.
Therefore, there is no provision in GCP for the head of the site or the investigational review committee to request a report in response to a notice from the sponsor regarding the interruption or discontinuation of a clinical trial.
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.