Abstract
Approximately 4 000 clinical trials are authorised in Europe each year. Activities related to providing of clinical trials and their documents are connected with very strict rules which are derived from principles of Good Clinical Practice (GCP) and legal rules.
In the Czech Republic, it means especially decree No. 226/2008 Coll. on good clinical practice and detailed conditions of clinical trials on medicinal products. Requirements defined in this decree brought to pharmacies needs how they could been practicaly figured out.
Because of these reasons major attention of the article will be paid to basic rules and directives which determinate the role of pharmacist in clinical trials. The activities of the pharmacists related to clinical trials, requirements on documents and needs of specialized skills and strong knowledge of necessary rules and directives will be described in this article.