Was betrifft es? Warum ist das wichtig?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies using transplant products.

 

Transplants products are:

  • From human or animal origin
  • Made from organs, tissues or cells
  • Whose manufacturing process can be standardized

 

The same provisions and risk-categories as defined for studies with Medicinal Product apply (see Medicinal Product studies). Consequently, studies with transplant products are divided into three risk categories (e.g. risk-categories A, B, or C apply, with A having the lowest and C the highest risk).

Was muss ich befolgen?

As a SP-INV planning a study with transplant products, you are required to know and comply with the requirements defined in the ClinO ordinance.

 

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

 

  • Ethics Committee (EC) who grants authorisation of risk-category A, B, and C studies. EC provides a reply, after the acknowledgement of receipt of the formally correct application documents (application dossier), within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies

 

  • Swissmedic who grants authorisation of risk-category B and C studies. Swissmedic provides provides a reply, after acknowledgement of receipt of the complete application douments (application dossier), within:
    • 30 days
    • A potential additional 30 days for first in human studies, or for transplant products manufactured in a new process
    • Risk-category A studies are exempt from Swissmedic authorisation

 

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. 21 Categorisation of studies of transplant products
  • Art. 26 Procedures and deadlines EC
  • Art. 27 Procedures and deadlines EC in multicentre clinical trials
  • Art. 33 Procedures and deadlines Swissmedic
  • 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
  • HumanRes – Human Research Switzerland
  • HRA – Human Research Act
  • ICD – International Classification of Diseases
  • MP – Medicinal Product
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplant Products
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 ↦ Transplant Products

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