Monitoring & Quality control
Mandatory quality control for clinical trials
Monitoring is a mandatory quality control for clinical trials with medicinal products and medical devices. The monitor verifies that the rights, safety and well-being of research subjects are protected and the accuracy of collected data. This is done by checking that protocols, legislations and regulations are followed and that study data are recorded correctly. Monitoring, even when it is not a legal requirement, can also be advantageous when carried out for other types of clinical studies to ensure the quality of the study.
Monitoring services in clinical studies
Clinical Studies Sweden offers monitoring services and can provide support with everything from the design of a monitoring schedule to the implementation of monitoring in the clinical study. We also offer templates and supporting documents to facilitate quality control of the clinical study.
Clinical Studies Sweden also offers a service for coordinated monitoring of investigator-initiated multicentre studies with study centres in different locations in the country. For this collaborative monitoring, the monitoring is coordinated via one of the nodes of Clinical Studies Sweden. Monitoring is then carried out by local monitors close to the study centre.