Requirements for study protocols according to the Human Research Act (HRA), the ordinance on clinical trials in human research (ClinO), the ordinance on clinical trials of medical devices (ClinO-MD) and the ordinance on human research with the exception of clinical trials (HRO)

This document must be submitted to the ethics committee and distributed to all investigators in Switzerland along with the study protocol if the study protocol was prepared using the ICH-M11 template «Clinical electronic structured harmonised protocol (CeSHarP)».