During category C clinical trials, sponsors have various authorisation and reporting obligations towards Swissmedic.
An application for authorisation has to be submitted to Swissmedic in the following cases:
- modifications that are likely to have a substantial impact on the safety, health or rights of the subjects
- or on the robustness or reliability of the clinical data generated by the clinical trial,
- change of sponsor.
The following must be reported to Swissmedic:
- Reportable serious adverse events (SAE), incl. possible serious device deficiencies.
- Safety and protective measures.
- An annual safety report comprising an updated written report and the list of SAEs incl. device deficiencies covered by the report must be submitted.
- Changes to the trial and documents that do not require authorisation.
- Completion, discontinuation or interruption of the trial and final report.
For more detailed information, see section 7 of Information sheet BW600_00_0015e_MB.
The procedures and documents prepared to satisfy the reporting obligations must be described in the trial investigation plan and recorded in the case report forms. These documents are reviewed during the Swissmedic authorisation procedure.
Incidents that occur during category A trials (trials not subject to Swissmedic authorisation) are subject to the reporting obligations for materiovigilance.