The regional cooperation body for research and innovation decided in its meeting on November 24, 2023, to strengthen the monitoring service. New is that the offer is now extended to include clinical studies that are not subject to mandatory monitoring. It is now possible to order monitoring of studies with increased risk.
Monitoring of clinical studies ensures that they are conducted, documented, and reported in accordance with the protocol, GCP, regulatory requirements, and relevant legislation. Monitoring is mandatory in drug studies and studies on medical devices that are to be CE marked. For other interventional studies, monitoring is optional. Experience from the Norwait study suggests that more studies than today should be monitored.
All health trusts in Helse Vest can report the need for monitoring. A form has been prepared as a guide for the trusts’ assessment of whether monitoring should be carried out. The completed form with relevant study documents is received by the monitoring service, which then assesses whether the study meets the criteria for the new scheme. Studies will be prioritized in case of high demand. A monitoring plan tailored to the individual study will then be prepared.
There is no co-payment for monitoring under this scheme.