Background

Swissmedic primarily conducts inspections for category B and C clinical trials. Inspections involve considerable effort for the research groups and researchers are charged for Swissmedic's efforts. In order to mitigate these cost risks for research projects, DKF now offers an inspection insurance.

Benefits

With a one-time contribution of CHF 1000 per study, the insured parties are covered as follows: DKF covers the costs invoiced by Swissmedic of up to CHF 15'000 per inspection. Likewise, the Quality Affairs Team supports the preparation and follow-up of the inspection.

Criteria for taking out a DKF inspection insurance

• The insurance is taken out before Swissmedic announces an inspection.
• The insurance covers an Investigator-initiated clinical trial.
• The Sponsor-Investigator of the trial is a member of a DKF research group.
• For multicenter studies, only the centre of the DKF research group is insured.
• The study must maintain a quality management system (QMS) with a dedicated person responsible for the QMS.