What is it? Why is it important?

The portal for human research, or the coordination office for research involving humans (KOFAM), is the FOPH 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 EC/RA, FOPH, 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

References

KOFAM: Coordination portal for human research – see in particular

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.305 ClinO

HRA – see in particular article

  • Art. 56 Registration

ClinO – see in particular chapter

  • Chapter 5 Registration
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • EU – European Union
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • 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 ↦ Portals ↦ Human Research Portal
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Portals ↦ Human Research Portal

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