Accepted principles for conducting clinical trials in humans are based on the protection of human rights and human dignity regarding the use of biology and medicine, as reflected in the text of the Declaration of Helsinki. The protection of clinical trial subjects is ensured by risk assessment based on the results of toxicological tests performed prior to any clinical trial, reviews by medical ethics committees and competent authorities of Member States, as well as on the rules on personal data protection. Legislation of the Republic of Slovenia related to clinical trials:
- Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14),
- Rules on clinical trials of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/06),
- Rules on fees in in the field of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 65/11),
- EU Legislation related to clinical trials:
Directives and recommendations of the European Committee: EudraLex – Volume 10 Clinical trials guidelines: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-10/index_en.htm
Regulation (EU) No. 536/2014 of the European Parliament and Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC:
http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_sl.pdf
