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.

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:

  • Medicinal products (MP)
  • Medicinal products in combination with medical devices (e.g. non-separable combinations of MP and device and where the MP assumes a primary function such as an insulin pump)
  • Transplantation and transplant products
  • In vitro diagnostic Medical Devices (MD) or products
  • Gene therapy and genetically modified organisms (GMO) and pathogenic organisms
  • Studies involving ionising radiation
  • Other clinical studies

More

In addition, the ordinance regulates:

  • EC/RA / FOPH authorisation and reporting procedures
  • EC/RA / FOPH duties and responsibilities
  • Study registration and public access

What do I need to do?

When performing studies involving human beings, you are required to know and comply with the HRA act, including its ordinances.

The Clinical Trial Ordinance provides:

  • Applicable articles and chapters according to 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”)
  • Definitions on how to risk categorise a study (e.g. A, B, or C with A having the lowest- and C the highest risk)
  • Criteria needed for EC, Swissmedic, and FOPH submission

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

References

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art. 1 Purpose
  • Art. 2 Definitions
  • Art.19 Categorisation of MP studies
  • Art. 20 Categorisation of studies of in vitro diagnostic MD and products
  • Art. 21 Categorisation of studies of transplant products: refer to Art. 19
  • 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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • 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
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Aim
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 ↦ Clinical Trials Ordinance ↦ Aim

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