Was betrifft es? Warum ist das wichtig?

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 studies with medicinal products capable of emitting ionising radiation, and studies with accompanying examinations involving ionising radiation. 

 

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.  

Was muss ich befolgen?

As a SP-IN, submit an application to the:

  • The Ethics Committee (EC) if additional concomitant examinations with ionising radiation measures are performed. Aspects to consider include:
    • To inform the EC of a FOPH application. The EC grants approval if the FOPH has no objections.

 

  • The FOPH, for risk-category B and C studies, if the:
    • Radiopharmaceutical is applied outside it’s authorization, or has no authorization in Switzerland
    • Medical Device is emitting radiation, and is used outside it’s product specification or has no CE-mark.

 

  • Swissmedic, for risk-category B and C studies. For category C studies.
    • Swissmedic will seek the opinion of the FOPH, who will review compliance with radiological protection legislation and dose estimation. Swissmedic grants study authorisation if the FOPH has no objections

 

Submission to Swissmedic (submission) and EC (submission) may be done in parallel. Submission to the second authority must be done within two years after approval of the first authority.

Wo kann ich Hilfe anfordern?

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. 11 Extension of the limitation period
  • Art. 25 j, k EC review area
  • Art. 32 Swissmedic review areas
  • Art. 36 Studies of medicinal products emitting ionising radiation
  • Art. 36a Accompanying examinations involving ionising radiation
  • Annex 3 Application documents to EC
  • Annex 4 Application documents to Swissmedic / FOPH

ClinO-MD - see in particular articles and section

  • Art. 14 Procedures for accompanying examinations involving ionising radiation
  • Art. 18 Studies with devices capable of emitting ionising radiation

RPA – see in particular article

  • Art. 28 Mandatory licencing
Abkürzungen
  • 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
  • HumRes - Human Research in Switzerland
  • 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 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 ↦ Ionising Radiation

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