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 interventional studies, with the exception of clinical trials of Medical Devices (ClinO-MD).

 

In these studies, participants are prospectively assigned to one or more interventions, which are evaluated based on its effect on health, bodily structure, and/or function.

 

The ordinance regulates studies with:

More

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 to information on clinical trials in Switzerland

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, or transplant products, or transplantation, 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 ClinO 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 Research Support Centre can assist you with experienced staff regarding this topic

  • Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

  • Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

  • Bern, Department of Clinical Research (DCR), dcr.unibe.ch

  • Geneva, Clinical Research Center (CRC), crc.hug.ch

  • Lausanne, Clinical Research Center (CRC), chuv.ch

  • St. Gallen, Clinical Trials Unit (CTU), h-och.ch

  • Zürich, Clinical Trials Center (CTC), usz.ch

References

HumRes: Coordination portal for human research in Switzerland

Swiss Law

ClinO – see in particular articles and annexes

  • Art. 1 Purpose
  • Art. 2 Definitions
  • Art.19 Categorisation of MP studies and transplant products
  • Art. 22 Categorisation of studies with gene therapy, genetically modified or pathogenic organisms: refer to Art. 19
  • Art. 49 Categorisation of transplantation studies
  • Art. 61 Categorisation of other clinical studies
  • Annex 3 Application documents to EC
  • Annex 4 Application documents to Swissmedic / FOPH
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HumanRes – Human Research Switzerland
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Aim

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