What is it? Why is it important?
Based on the planned study, different laws, regulations, directives and guidelines apply.
For interventional studies with an Interventional Medicinal Product (IMP) including other types of studies (e.g. transplantation, surgery, psychology, physiotherapy), the following laws and guidelines apply:
For medical device studies, the following laws and guidelines apply:
For research projects involving the sampling of biological material or collection of health-related personal data (including further use), the following laws and guidelines apply:
Also consider the following not legally binding documents for Biobanks:
- Declaration of Taipei
- ISO 20387 Biobanking
What do I need to do?
Know what applicable laws, regulations, directives and guidelines apply to your study.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
- ICH GCP E6(R2)
- HRA - Human Research Act
- ClinO – Clinical Trials Ordinance
- ClinO-MD – Ordinance on Clinical Trials with Medical Devices
- HRO – Human Research Ordinance
- FADP – Federal Act on Data Protection
- MedDO – Medical Devices Ordinance
World Medical Association – see in particular current declarations
- Declaration of Helsinki 2013 Ethical principles for medical research involving human subjects
- Declaration of Taipei 2016 on ethical considerations regarding databases and biobanks
ISO (access liable to costs) – see in particular sections
- 14155:2020 Medical device
- 20387:2018 Biobanking