Concept↦Ethics and Laws↦Study Planning↦Laws and Guidelines
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:
- Declaration of Helsinki
- ICH GCP E6(R2)
- FADP
- HRA
- ClinO
- TPA
For medical device studies, the following laws and guidelines apply:
- Declaration of Helsinki
- ISO 14155
- FADP
- HRA
- ClinO-MD (with references to ClinO)
- MedDO
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:
- Declaration of Helsinki
- ICH GCP E6(R2) recommended as applicable
- FADP
- HRA
- HRO
Also consider the following not legally binding documents:
- 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
References
ICH GCP E6(R2)
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
Swiss Law
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
- 235.1 FADP
- 810.30 HRA
- 810.301 HRO
- 812.213 MedDO
- 812.21 TPA