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):

Protocol template according to ClinO, for Investigator initiated trials (IIT)

Protocol template according to ClinO chapter 4: other clinical trials

Clinical Investigation Plan (CIP) for investigations with medical devices (template for Investigator initiated trials (IIT)).  

Clinical Performance Study Plan (CPSP) for IVD devices performance studies (template for Investigator initiated trials (IIT)).

Project plan template: Research involving human subjects with the exception of clinical trials

Template for the submission of a project "further use with consent" according to HRA/HRO

Note: Use the template for the submission of a project "further use without consent" according to HRA Art.34/HRO in case there is no consent for some or for all the health-related personal data and/or biological material used in the research project.

Template for the submission of a project "further use without consent" according to HRA Art.34/HRO

Template for the submission of a project involving deceased persons, according to HRA/HRO

Template for the summary of the study protocol (Synopsis)