News & Media

Increasing patient safety in clinical trials – new protocol deviations routemap released

We are pleased to announce the release of a new tool to help trial teams manage protocol deviations.

Clinical trials follow a protocol that is often more than 100 pages long. The protocol describes all the trial processes including everything about how potential participants should be approached, how treatment should be delivered, and the follow-up regimen.

Whenever an action occurs (or does not occur) as described in the protocol, there is a risk for participants. These protocol deviations need to be logged and reviewed. Should there be an immediate change to the protocol? Is the deviation a serious breach which should be reported to the UK regulator (MHRA)? Are there changes to the protocol that would make the trial easier for patients or site staff or those at the Clinical Trials Unit?

To help navigate protocol deviation processes and increase trial participant safety, we have created a protocol deviation routemap to guide those running clinical trials through the protocol deviation process and provide a safer clinical trial for participants.

You can view or download a copy of the routemap here.