Was betrifft es? Warum ist das wichtig?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies on transplantation of human organs, tissues, and cells.

For studies on transplantation the risk-categories A or C apply, with A having a low and C a high risk

 

Risk-Category A includes studies with transplatation:

  • That are recognised as standard guidelines, prepared in accordance with internationally accepted quality criteria

 

Risk-Category C includes studies with transplatations:

  • That are not recognised as standard, as specified under risk-category A
  • With embryonic and foetal tissues and cells

Was muss ich befolgen?

As a Sp-INV planning transplantation studies with human organs, tissues, and cells, you are required to know and comply with requirements defined in the ClinO ordinance:

 

Based on the risk-category, submit your application dossier to:

  • The Ethics Committee (EC) who provides a reply, after acknowledgement of receipt of the formally correct application documents (application dossier) , within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies

 

  • The Federal Office of Public Health (FOPH) who grants authorisation of risk-category C studies. The FOPH provides a reply, after acknowledgement of receipt of the formally correct application documents (approval), within 30 days:

 

Risk-category A studies are exempt from FOPH authorisation

 

As the EC and FOPH coordinate their assessments, the EC submission and FOPH submission may be done in parallel.

For category C studies 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. 33 Procedures and deadlines FOPH
  • Art. 49 Categorisation of studies of transplantation
  • Art. 51 Procedures and deadlines EC
  • Annex 3 Application documents to EC
  • Annex 4 Application documents to Swissmedic / FOPH
Abkürzungen
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HumanRes – Human Research Switzerland
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation
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 ↦ Transplantation

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