What is it? Why is it important?

The Human Research Act (HRA) regulates through its ordinances (e.g. ClinO, ClinO-MD) additional requirements for studies using a radiation source.


A radiation source can be combined with a Medicinal Product (ClinO), a Medical Device Product (ClinO-MD), or based on a combination from both products.


The HRA and its ordinances apply to investigations and (diagnostic) examinations (e.g. CT scan, X-rays, etc.) using an effective person dose exceeding 5 mSv per year.


In addition it applies to radiopharmaceutical products under investigation that:

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

What do I need to do?

As a SP-INV of studies investigating products capable of emitting ionising radiation, you are required to know and comply with requirements defined in the ClinO/ClinO-MD ordinances.


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
  • Ethics Committee (EC) who grants authorisation of all studies (e.g. study risk-categories)
  • Swissmedic who grants authorisation of category B and C studies


The FOPH delivers its opinion to EC with respect to compliance with:

  • Radiological protection legislation
  • The dose estimation


EC, FOPH, and Swissmedic submission must 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


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

  • Art. 2, 6 Definition
  • Art. 11 Extension of the limitation period
  • Art. 25 j, k EC review area
  • Art. 28 Procedures for investigations involving radiation sources
  • Art. 32 Swissmedic review areas
  • Art. 36 Studies of medicinal products emitting ionising radiation

ClinO-MD - see in particular articles and section

  • Art. 14 Procedures for investigations involving radiation source
  • Art. 18 Studies with devices capable of emitting ionising radiation
  • Section 3. Reporting in relation with the use of radiation sources and document retention

RPA – see in particular article

  • Art. 28 Mandatory licencing
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • 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

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 ↦ Ionising Radiation

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