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 clinical trials

Protocol template according to ClinO chapter 4: other clinical trials

Clinical Investigation Plan (CIP) for investigations with medical devices.

Clinical Performance Study Plan (CPSP) for IVD devices performance studies

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)