Drug Evaluation Committee 2016-33 Timing for Submission of Clinical Trial Termination Report (Part 3)
Related classification: Clinical Trial Review Committee
Date of first publication: October 2016
Question
Is there any problem if I submit a clinical trial termination report beyond the clinical trial period? Please let me know if the Clinical Trial Review Committee needs to review the extension.
The Visit stipulated in the clinical trial protocol will end within the period of the clinical trial protocol (clinical trial agreement), but there is now a possibility that a follow-up may occur. Therefore, the submission of the Termination Report will also exceed the duration of the clinical trial. Although the study protocol itself will not be extended, since the subject handling will continue, is it necessary for the Clinical Trial Review Committee to review the extension? If not, may we submit a termination report beyond the period?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When a clinical trial is terminated, the investigator must report to that effect and a summary of the results in writing to the head of the site (GCP Article 49, Paragraph 3). Therefore, when a clinical trial is terminated, a report on the termination of the clinical trial must be submitted to the head of the site. However, there is no provision in the GCP that states that such a report must be submitted during the clinical trial period as stipulated in the protocol or clinical trial agreement.
In the case in question, it seems that the medication and observation specified in the protocol have been completed, so if it is possible to fulfill the requirements specified in the report at the medical institution, a termination report should be submitted, and at that time, a report stating that a follow-up survey is being conducted on some of the subjects should be submitted. If you are able to fulfill the requirements for reporting at the medical institution, we believe that there is no problem in submitting a termination report and reporting that you are conducting a follow-up survey on some subjects.