Risk assessment

According to Good Clinical Practice the conduct of the trial has to be adapted to the risk inherent to the investigational medicinal products, the study procedures, the organisation, the data management etc, see SOP Quality and Risk Management, point 4.1.1. Also a plan for future risk assessments should be written.

The risk assessment should be undertaken before study start-up. Template Risikovurdering (Norwegian) can be used. It is important to describe the functions responsible for controlling the different risks. The risk that should be controlled by monitors should be reflected in the Monitoring Plan. Monitoring is a legal obligation to check certain aspects of the study conduct, see SOP Monitoring. More information about tools for monitoring can be found on a page for monitors. The risk assessment will be of value when defining which protocol deviations to focus on, see Documentation of protocol deviations.