What is it? Why is it important?

In order to guarantee research transparency all studies should be registered. The following registration guidelines apply.


Studies (e.g. ClinO, ClinO-OthersClinO-MD), irrespective of risk-category must be registered in:

  • An international public registry, namely in:
    • A primary registry recognised by the World Health Organization (WHO), or
    • The registry of the U.S. National Library of Medicine - clincialtrials.gov
  • A federal database, such as the SNCTP (Swiss National Clinical Trials Portal) to be found on the KOFAM website. Note: all information must be entered in a Swiss national language


The SP-INV is responsible for the accuracy and completeness of all data entered in the registry.


Registration of HRO projects is not required. Still, project registration promotes research transparency, and increases the chance for journal publication. Research projects can be registered in the “Registry of all projects in Switzerland” (RAPS) by swissethics.

What do I need to do?

As a SP-INV, familiarize yourself with how to register your study. Procedures include to:

  • Register the study upon EC/RA (e.g. Swissmedic) approval but prior to study conduct. An exception are first in human studies that must be registered no later than 1 year after completion.
  • Enter study information in an international public registry and transfer the allotted ID back into BASEC (swissethics submission portal). By activating the data transfer button in BASEC your study information is automatically transferred to the federal database (SNCTP)
  • Enter and update study information in accordance with requirements of the registry in question, but at least once a year


In order to allow for the automatic data transfer from BASEC to SNCTP, activate in BASEC the button with the following text:

  • “I agree to the automatic transfer of the relevant data into SNCTP”

Where can I get help?

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

External Links

Swissethics – see in particular

  • BASEC: EC submission portal
  • RAPS: EC approved projects in Switzerland
  • SNCTP: FOPH Swiss national clinical trial portal


For study registration access:

Swiss Law

HRA - see in particular article

  • Art. 56 registration

ClinO – see in particular articles

  • Art. 64-67 Registration

ClinO-MD - see in particular article

  • Art. 41 Registration
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Author
  • HRO – Human Research Ordinance
  • KOFAM – Coordination Portal for Human Research
  • RAPS – Registry of all Projects in Switzerland
  • SNCTP – Swiss National Clinical Trials Portal
  • SP-INV – Sponsor-Investigator
  • WHO – World Health Organisation
Set-Up ↦ Management ↦ Registration ↦ Research Transparency

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): Set-Up ↦ Management ↦ Registration ↦ Research Transparency

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