The Agency may at any time carry out an inspection to determine whether the conduct of the clinical trial meets the requirements specified in this Act and in the Human Research Act of 30 September 20111.
The Federal Council may, having regard to recognised international regulations, specify notification and information requirements, concerning in particular:
the completion or discontinuation of a clinical trial;
adverse events observed in connection with a clinical trial;
incidents occurring during the conduct of a clinical trial which may affect the safety or health of the participants or call into question the acquisition of reliable and robust data.
It shall regulate the notification procedure and the exchange of information. It may stipulate that notification and the exchange of information must be effected electronically.