Was betrifft es? Warum ist das wichtig?

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

 

Study set-up and type will decide the risk-category of the study (e.g. risk-categories A, B, or C apply, with A having the lowest and C the highest risk).

 

Risk-Category A includes transplatation studies:

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

 

Risk-Category C includes transplatation studies:

  • 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:

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

 

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

  • The Ethics Committee (EC, application dossier) who grants authorisation of risk-category A, B, and C studies, and provides a reply within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies
  • The Federal Office of Public Health (FOPH, approval) who grants authorisation of risk-category B and C studies, and provides a reply:
    • 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 must be done in parallel.

Wo kann ich Hilfe anfordern?

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

ClinO – see in particular articles

  • Art. 33 Procedures and deadlines FOPH
  • Art. 49 Categorisation of studies of transplantation
  • Art. 51 Procedures and deadlines EC
Abkürzungen
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • KOFAM – Coordination portal for human research
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 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 Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation

Please note: the Easy-GCS tool is currently under construction.