What is it? Why is it important?

The Transplantation Act defines requirements for the use of human or animal organs, tissues or cells for transplantation purposes into humans.

The act:

  • Applies to the handling of organs, tissues or cells, and products intended for transplantation into humans
  • Contributes to the availability of human organs, tissues, and cells for transplantation purposes
  • Prevents the improper handling of organs, tissues, or cells in:
    • Human transplantation medicine
    • Commercial activities
  • Protects human dignity, privacy, and health

Organ transplantation is a medical procedure that involves the replacement of a missing or damaged organ by a medically intact organ.

What do I need to do?

When performing human transplantation studies, you are required to know and comply with the requirements in the Transplantation act.

Read the Transplantation act and its ordinance, and based on your study:

  • Be familiar with the organisation of the various chapters and sections
  • As applicable, tag relevant articles that need to be complied with in your study

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.21 Transplantation act
  • 810.211 Transplantation ordinance

Transplantation Act – see in particular articles

  • Art. 1 Aim
  • Art. 2 Scope

Transplantation ordinance – see in particular article

  • Art.1 Purpose and scope
  • CTU – Clinical Trials Unit
  • FEDLEX – Publication Platform for Federal Laws
Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Transplantation Act

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking

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
Set-Up Biobanking

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Transplantation Act

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