What is it? Why is it important?

KOFAM is the Federal Office of Public Health (FOPH) coordination portal for human research in Switzerland


The KOFAM website provides extensive basic information needed for the implementation of human studies, such as:

  • The risk categorisation of human studies (e.g. influencing factors, what authorisation procedures apply, what conditions must be fulfilled)
  • Application procedures (e.g. authorisation requirements, submission procedures to the Ethics Committee (EC), Regulatory Authorities (e.g. Swissmedic), FOPH, Federal Office for the Environment (FOEN))
  • Regulatory updates (e.g. the Swiss law, applicable EU laws)
  • The SNCTP study registry, where all BASEC submitted studies / projects are listed

What do I need to do?

As a SP-INV or project-leader make sure to register your study / project in the SNCTP registry under KOFAM. Make appropriate updates during study conduct and document the completion or interruption of your study.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Experienced staff at your local CTU can provide you with support on this topic

External Links

Swissethics  – see in particular  


KOFAM: Coordination portal for human research – see in particular

  • The SNCTP portal for study registration
  • Online wizard for risk categorisation
  • Applications & procedures

FOPH – Federal office of Public Health

FOEN – Federal Office for the Environment

SNCTP - Swiss National Clinical Trial Portal

Swiss Law

HRA – see in particular article

  • Art. 56 Registration

ClinO – see in particular chapter

  • Chapter 5 Registration
  • BASEC – Business Administration System for Ethics Committees
  • EU – European Union
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • KOFAM – Coordination Office for Human Research
  • SNCTP – Swiss National Clinical Trial Portal
  • SP-INV – Site Investigator
Basic ↦ Ethics and Laws ↦ Human Research Coordination Portal ↦ Federal Office of Public Health

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Human Research Coordination Portal ↦ Federal Office of Public Health

Please note: the Easy-GCS tool is currently under construction.