During category C clinical trials, sponsors have various approval and reporting obligations towards Swissmedic.
Substantial modifications
An application for approval has to be submitted to Swissmedic in the following cases:
- Changes that could have a significant impact on the safety, health or rights of the participants
- Changes that could have a significant impact on the robustness or reliability of the data generated by the study
- Change of sponsor
Substantial modifications in Switzerland
In Switzerland, you will always receive a written decision concerning substantial modifications to an approved clinical trial, and there are no waiting periods with tacit procedures.
You can find examples of substantial modifications to clinical investigations with medical devices on the websites of the European Commission (e.g. MDCG 2021-6). You can find additional examples and an overview of submissions in Switzerland in a publication issued by swissethics and Swissmedic (Guidance document on “Substantial modifications to clinical investigations of medical devices”). Similar examples for substantial modifications to performance studies with IVDs have not yet been published
Reporting and notification duties
The following must be reported or notified to Swissmedic:
- Serious adverse events that have a causal relationship with the investigational device, the comparator device or the study procedure or where such causal relationship is reasonably possible;
- Device deficiencies that might have led to serious adverse events if appropriate action had not been taken, intervention had not occurred or circumstances had been less fortunate;
- Safety and protective measures;
- Annual report on the safety of participants and on the general progress of the clinical trial;
- Other modifications that do not need to be approved;
- Completion, premature termination or interruption of the trial and final report.
For more information, see section 7 of Information sheet BW600_00_0015e_MB/ BW600_00_0016e_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 approval procedure.