What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) requirements needed for the conduct of human health-related interventional studies, excluded are clinical trials of Medical Devices.


In these studies, participants are assigned to a health-related intervention, which is evaluated based on its effect on health, bodily structure, and/or function.


Interventional studies include any preventative, diagnostic, therapeutic, palliative, or rehabilitative measure based on the use of a:


In addition, the ordinance regulates:

  • Ethics Committee (EC) / RA (e.g. Swissmedic) / Federal Office of Public Health (FOPH) authorisation and reporting procedures
  • EC/RA/ FOPH duties and responsibilities
  • Study registration and public access

What do I need to do?

As a SP-INV and Site-INV performing studies involving human beings, you are required to know and comply with the HRA act and its ordinances.


The Clinical Trial Ordinance:

  • Is divided into chapters and articles based on study type (e.g. interventions with the use of a MP, MP in combination with a MD, transplantation or transplant products, or “other clinical trials”)
  • Defines risk-categories based on expected study risks (e.g. A, B, or C with A having the lowest- and C the highest risk)
  • Lists Ethics Committee (EC), RA (e.g Swissmedic), and Federal Office of Public Health (FOPH) submission requirements


Read the ClinO ordinance and based on your study:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study. Tag them in order to ensure compliance

Where can I get help?

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


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

  • Art. 1 Purpose
  • Art. 2 Definitions
  • Art.19 Categorisation of MP studies
  • Art. 22 Categorisation of studies with genetically modified or pathogenic organisms: refer to Art. 19
  • Art. 49 Categorisation of transplantation studies
  • Art. 61 Categorisation of other clinical studies
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • GMO – Genetically Modified Organisms
  • HRA – Human Research Act
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • MP – Medicinal Product
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Aim

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 ↦ Clinical Trials Ordinance ↦ Aim

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