Documentation of deviations in the planning stage

It is necessary to agree how deviations are to be documented and collected (see SOP Protocol Deviation Handling section 4.2), and a plan must be prepared (see Protocol Deviation Handling Plan).

It is best to have an electronic online solution for collecting deviations. If this is not possible, you must consider a paper-based solution for reporting deviations (see Protocol Deviation Notification and Tracking Form). All deviations must then be logged (see Protocol Deviation Log Single Center Study or Protocol Deviation Log Multicenter Study).