What is it? Why is it important?

Beyond regulatory requirements for IMPs, IMDs including their combinations, the Human Research Act (HRA) regulates, through its ordinance (ClinO), additional requirements for investigations using radiation sources.

Requirements apply to investigations as well as (diagnostic) examination (e.g. CT scan, X-rays, etc.) using an effective person dose exceeding 5 mSv per year. In addition the radiopharmaceutical product under investigation:

  • Is not authorised in Switzerland
  • Is authorised in Switzerland, but where the investigation is not a routine nuclear medical examination, or
  • Another radioactive source is used altogether

The regulatory requirements and approvals for studies with radiation sources, are beyond existing regulatory requirements for studies with IMP, IMP/IMD combinations.

What do I need to do?

For studies investigating products capable of emitting ionising radiation, you are required to know and comply with requirements defined in the ClinO ordinance.

Aspects to consider:

  • The authorization status of the radiopharmaceutical under investigation (e.g. approval status in Switzerland)
  • Planned radiation dose and participant exposure
  • Required licence for administering radioactive substances to humans
  • Completion of the required research application form for FOPH submission

Submit an application to:

  • The FOPH, if the effective dose per person > 5 mSv per year
  • EC who grants authorisation of category A, B, and C studies and provides its first reply within:
    • 45 days, if the FOPH raises no objection to the study
  • Swissmedic who grants authorisation of category B and C studies and grants its first reply within:
    • 60 days, if the FOPH raises no objection to the study

More

The FOPH delivers its opinion to EC with respect to:

  • The compliance with radiological protection legislation and on the dose estimation

EC, FOPH, and Swissmedic submission can be done in parallel as they coordinate their assessments.

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 – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 814.50 RPA

ClinO – see in particular articles

  • Art. 28 Procedures and deadlines EC
  • Art. 36 Special provisions

RPA – see in particular article

  • Art. 28 Mandatory licencing
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • 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
  • IMP – Investigational Medicinal Products
  • IMD – Investigational Medicinal Device
  • mSv – Millisievert
  • RPA – Radiological Protection Act
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Ionising Radiation
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 ↦ Ionising Radiation

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