- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
1.1 Justification for the trial
It is important for anyone preparing a trial of a medicinal product in humans that the specific aims, problems and risks or benefits of a particular clinical trial be thoroughly considered and that the chosen options be scientifically sound and ethically justified.