- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
3. PROTECTION OF TRIAL SUBJECTS
The personal integrity and welfare of the trial subjects as defined in the Declaration of Helsinki should be the primary concern of all parties involved in the conduct of a clinical trial and the review of the protocol but it is the ultimate responsibility of the investigator, who must also take into consideration the scientific validity of the trial.