Laws, Regulations and Other Useful Documents
Legislation
Links by Google Chrome
- Therapeutic Products Act (TPA)
- Human Research Act (HRA)
- Ordinance on Clinical Trials in Human Research (ClinO)
- Ordinance on Human Research with the Exception of Clinical Trials (HRO)
- Ordinance on Organisational Aspect of the Human Research Act (OrgO-HRA)
- Implementing Regulation of the Federal Act on Research involving Human Beings (K 4 06.02 RaLRH)
- Declaration of Helsinki
- EUROPEAN COMMISSION DIRECTIVE 2005/28/EC
- DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6 (R2) (International Council for Harmonisation)
- Biobanks: Sampling, storage and use of human biological material for training and research
Official Organisations
- Cantonal Research Ethics Committee (CCER)
- Swissmedic (Clinical trial authorisation)
- Association of Swiss Ethics Committees on research involving humans (Swissethics)
- European Medicines Agency (EMA)
- FDA's Guidance Documents and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials
- Clinicaltrials.gov (A service of the National Institutes of Health-USA)
- French National Agency for Medicines and Health Products Safety (ANSM)
- National Council on Ethics in Human Research
- Council for International Organizations of Medical Sciences (CIOMS)
- Swiss Academy of Medical Sciences (SAMS)
Biobanks
- Best Practices for Repositories : https://www.isber.org/page/BPR
- BBMRI-ERIC : https://directory.bbmri-eric.eu/
- Sampling, storage and use of human biological material for training and research
Any investigator HUG wishing for help or a settlement can directly contact Mr Julien VIRZI: julien.virzi@hcuge.ch