Monitoring & Quality control

Monitoring in Clinical Studies

Monitoring is a mandatory quality control measure for clinical trials involving medicinal products and medical devices. The monitor verifies that the rights, safety, and well-being of research subjects are protected and that the collected data is accurate. This is done by reviewing compliance with the study protocol, applicable laws and regulations, and ensuring that the study data is recorded correctly. Even when not legally required, monitoring can be a valuable tool to ensure the quality of other types of clinical studies.

Our research support

Monitoring Services

Clinical Studies Sweden offers monitoring services and can provide support with everything from developing a monitoring plan to conducting monitoring throughout the clinical study.

Coordinated Monitoring

Clinical Studies Sweden has developed a process for coordinated monitoring of investigator-initiated multicentre studies with study sites across Sweden. In coordinated monitoring, the process is managed by a monitor or monitoring organisation, and the actual monitoring is carried out by local monitors close to each study site.

Templates and Supporting Documents

To facilitate quality control in clinical studies, we have developed templates and supporting documents. Most documents are available in Swedish, and a selection is also available in English.

Templates and supporting documents for coordinated monitoring (in Swedish)