Documentation of protocol deviations

To be able to monitor the quality of the trial, it is important to have a good system in place for reporting of protocol deviations, see SOP Protocol Deviation Handling, point. 4.2. For each trial a specific handling plan should be written, see Protocol Deviation Handling Plan.

The best is to have an electronic system to gather deviations and if it is a multicenter trial, the system should be web based. If that is not possible, the following tools can be used: