Substantial modifications to an approved clinical trial, in accordance with Article 15 paragraph 1, must be submitted to Swissmedic for approval prior to their implementation. This obligation does not extend to measures that have to be taken immediately to protect trial participants.
The sponsor shall submit to Swissmedic the application documents as specified in Article 16 paragraph 1 that are affected by the modification. The sponsor shall submit information on the nature of and reasons for the modifications at the same time.
Swissmedic shall make its decision within 38 days of receiving all the application documents affected by the modification. Article 19 applies mutatis mutandis. This period may be extended by seven days.
Other modifications applicable to the application documents submitted to Swissmedic must be notified to Swissmedic as quickly as possible.
For conformity-related clinical trials in sub-categories C1 and C2 that are also being conducted, or are also due to be conducted, in states of the European Union (EU) or the European Economic Area (EEA), the sponsor shall notify Swissmedic of the reasons for and nature of substantial modifications to the clinical trial in EU or EEA states that affect the clinical trial plan, the device to be investigated or the instructions for use for the device to be investigated.60
The sponsor of a conformity-related clinical trial in sub-categories C1 and C2 shall also notify the contracting states in which the clinical trial is being conducted or is due to be conducted of the nature of and reasons for the modifications; it shall attach the documents as specified in Annex 1 which are affected by the modifications.