Risk assessment in the planning stage
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 controlling the various risks. The risks to be controlled by monitoring must be incorporated into a monitoring plan. Monitoring is a statutory quality control of the implementation of the trial (see SOP Monitoring). More information about the tools to be used can be found here. 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 the page Documentation of deviations in the planning stage).