Clinical Trial in accordance with 378/2007 Sb.,2001/20/ES, E6 ICH GCP, CIOMS, NIH and CFR

Abstract

What really is the clinical trial? What legislation of the Czech Republic, European Union and ICH GCP, CIOMS CFR and NIH says about clinical trial? Clinical trials are heavily discussed within both professionals and lay people around the world. Do we really know if our perception of clinical trials is correct?

Keywords

• Clinical Trial
• Czech law
• CIOMS
• NIH
• GCP
• EU directive