Risk assessment and monitoring plan

SOP Quality and Risk Management, section 4.1.1.

If not already done, a risk assessment must be made before the trial starts. This template can be used. It is important to decide who is responsible for checking the various risks. The risks to be checked by monitoring must be incorporated into a monitoring plan. Furthermore, a plan for further risk assessment should be set up.

The writing of the monitoring plan may also be affected by the deviations about which it is desirable to receive continuous reporting (see Documentation of deviations).