Drug Evaluation Committee 2013-50 Procedures for Discontinuation of Clinical Trial by Notification from the Sponsor
Related classification: Clinical trial contract 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)
- *(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
JPMA's Opinion
When a clinical trial is suspended or discontinued at the sponsor's discretion, the sponsor must promptly notify the heads of all Investigator Sites involved in the clinical trial in writing to that effect and the details of the reasons (GCP Article 24, Paragraph 2). Furthermore, the Chairperson of the Investigator Site who receives such notification must notify the investigator and the Clinical Trial Review Committee, etc., 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 Investigator Site a summary of the clinical trial up to its interruption or discontinuation.
Therefore, there is no provision in GCP that requires the Investigator Site Director or the Clinical Trial Review Committee to report to the sponsor in response to the notification of the interruption or discontinuation of the clinical trial, and the Investigator Site or the Clinical Trial Review Committee will respond to such requests on an individual basis as necessary.
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).