Drug Evaluation Committee 2021-40: On the Necessity of IRB Review for Amendments to Clinical Trial Protocols After the Completion of a Clinical Trial
Related Category: Institutional Review Board
Initial Publication Date: October 2021
Question
This is
a question regarding amendments to the clinical trial protocol after the trial has concluded
.
The currently ongoing clinical trial is a multicenter trial. The trial itself has concluded at each Investigator Site, and at this time, the principal investigators at all Investigator Sites have submitted completion reports to the heads of their respective institutions.
Although the work at the Investigator Sites has been completed, due to a change in the specifications of the data analysis system, it has become highly likely that some of the analyses described in the clinical trial protocol will not be performed.
If we do end up amending the clinical trial protocol, our internal ethics committee plans to follow the procedures for protocol amendments; however, since the trial has already been completed at each Investigator Site, they are unable to review the updated protocol.Please note that the amendment to the clinical trial protocol merely involves omitting a portion of the originally planned analyses and does not involve any changes related to the ethical treatment of trial participants.
In this case, would it be permissible for the Investigator Sites to proceed with the analysis by following only the internal ethics committee’s protocol amendment procedures—without submitting the amended protocol to the Institutional Review Board (IRB) for review?