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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
Experienced staff at your local CTU can provide you with support on this topic
KOFAM: Coordination portal for human research – see in particular
- The SNCTP portal for study registration
- Online wizard for risk categorisation
- Applications & procedures
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