Criteria for validity

• Conclusion of inspection insurance BEFORE 15.04.2025 (Note: Inspection insurances are no longer offered since 15.04.2025),
• the insurance was taken out BEFORE the announcement of an inspection by Swissmedic,
• it was taken out for an investigator-initiated clinical trial of category B or C,
• the sponsor-investigator of the clinical trial is a member of a DKF research group,
• the study maintains a quality management system with a defined responsible person.

Scope of existing inspection insurances

• The following are covered
  • inspections by Swissmedic only,
  • in the case of multi-center studies, only the center of the DKF Research Group (contractual partner),
  • expenses invoiced by Swissmedic per inspection up to a maximum of CHF 15'000,
  • support from the DKF Quality Affairs team in the context of the announced inspection:
    • Preparation: presentation with opportunity to ask questions,
    • Support on the day of the inspection,
    • Follow-up: support with the preparation of CAPA plans after receipt of the inspection report.