Study protocols

Templates and documents that were updated in the last 2 months are marked with green color.

Requirements for study protocols according to the Human Research Act (HRA)

Requirements for study protocols according to the Human Research Act (HRA), the ordinance on Clinical Trials in Human Research (ClinO) and the ordinance on Human Research with the Exception of Clinical Trials (HRO):

English
4.0
updated: 31.05.2021
Clinical trials according to ClinO

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

English
1.0
updated: 15.04.2021
Clinical trials according to ClinO chapter 4: Other clinical trials

Protocol template accoring to ClinO chapter 4: other clinical trials

English
1.1
updated: 02.12.2020
Clinical investigations (clinical trials) with medical devices according to ClinO-MD

Clinical Investigation Protocol template for Investigator initiated trials (IIT)

English
1.0
updated: 15.04.2021
Research projects with persons (HRO chap. 2) (Human research other than clinical trials)

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

English
2.2
updated: 20.04.2020
Further use with consent (HRO chap. 3)

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

Deutsch
3.0
updated: 11.11.2020
Français
3.0
updated: 11.11.2020
Italiano
3.0
updated: 11.11.2020

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.

Further use without consent (HRO chap. 3)

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

Deutsch
3.0
updated: 11.11.2020
Français
3.0
updated: 11.11.2020
Italiano
3.0
updated: 11.11.2020
Research involving deceased persons

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

Deutsch
1.0
updated: 20.07.2019
Français
1.0
updated: 19.07.2019
Italiano
1.0
updated: 22.09.2017
Protokollsynopsis

Template for the summary of the study protocol (Synopsis)

Deutsch
1.1
updated: 17.04.2019
Français
1.1
updated: 17.04.2019
Italiano
1.1
updated: 17.04.2019
English
1.1
updated: 17.04.2019