Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Transplant Products
What is it? Why is it important?
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).
What do I need to do?
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.
Where can I get help?
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