What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) “other clinical studies” which do not include the use of:

  • A Medicinal Product (MP)
  • In vitro diagnostic Medical Devices (MDs) or products
  • Combination of MP and MD
  • Combination of non-viable human tissue/cells and MD
  • Transplantation and transplant products

These studies use or implement other types of medical, psychological, or physiological interventions or procedures (e.g. surgery, psychotherapy, physiotherapy, behavioural sciences, diet and nutrition).

Based on the study intervention, risk categories A or C apply, with A having a low and C a high risk.

More

Categorisation of health-related interventions in “other clinical studies”:

Category A: if the study

  • Entails only minimal risks and burdens; or
  • Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria

Category B if the study:

  • Entails more than minimal risks and burdens; and
  • Is not recognised as standard as specified under category A

In particular, minimal risks and burdens may be associated with:

  • Surveys and observations
  • Peripheral venous or capillary blood sampling and skin punch biopsies of limited extent
  • Non-invasive interventions removing or collecting bodily substances, in particular, saliva, urine and stool samples
  • Taking swabs
  • Magnetic resonance imaging scans without a contrast medium
  • Ultra-sound examinations or electrograms
  • Examinations using MDs which bear conformity markings and without using a contrast medium, or using authorised MP capable of emitting ionising radiation, provided that the effective dose is below 5 mSv per research project and per person concerned

What do I need to do?

For “other clinical studies” you are required to know and comply with the requirements defined in the ClinO ordinance:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study

“Other clinical studies” must be submitted and approved by the EC prior to implementation.

Thus, submit your application dossier to EC, who provides a reply within:

  • 30 days for monocentric studies
  • 45 days for multi-centre studies

Studies that fall under the category of “other clinical studies” in ClinO, are exempt from submission and approval by regulatory authorities (e.g. Swissmedic, FOPH).

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Other clinical trials

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. 2 Definition of minimal risks and burdens
  • Art. 61 Categorisation of other clinical studies
  • Art. 62 Procedures and deadlines EC
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • KOFAM – Coordination portal for human research
  • MD – Medical Device
  • MP – Medicinal Product
  • mSv – Millisievert
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Other Clinical Studies
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 ↦ Other Clinical Studies

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