Drug Evaluation Committee 2021-40 Necessity of Clinical Trial Review Committee Review of Changes to Clinical Trial Protocol after Clinical Trial Completion
Related classification: Clinical Trial Review Committee
Date of first publication: October 2021
Question.
I have a question regarding changes to the clinical trial protocol after the completion of a clinical trial.
The ongoing clinical trial is a multicenter clinical trial, and the clinical trial itself has been completed at each Investigator Site, and at this point, the investigators at all Investigator Sites have submitted the completion report to the head of the Investigator Site.
Although the Investigator Site has completed its work, due to a change in the specifications of the data analysis system, there is a high possibility that some of the analyses described in the study protocol will not be performed.
In the event that we actually decide to change the protocol, the Ethics Committee of the company is planning to implement the procedures for changing the protocol, but since the Investigator Sites have already terminated the clinical trial, we are unable to review the updated protocol. The changes to the protocol are only that some of the planned analyses will not be conducted, and are not related to the ethical aspects of the subjects.
In this case, is it acceptable for the Investigator Site to proceed with the analysis by implementing the procedures to change the study protocol only by the in-house Ethics Committee, without having the Investigator Site review the changed study protocol by the Trial Review Committee?