The EU Directive: Practical Implications for Clinical Research Teams
New requirements for clinical research teams, and administrative responsibilities and constraints for investigators conducting noncommercial trials. The Directive 2001/20/EC on clinical research covers a wide sweep of issues on interventional trials which have implications for clinical research teams, including the suitability of investigators and the quality of facilities, informed consent, ethics committees, noncommercial trials, and the European clinical trials database (EUDRACT).
