- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.6 The investigational product
The investigator must be thoroughly familiar with the properties, effects and safety of the investigational pharmaceutical product(s), including pre-trial data, as described in the investigator’s brochure or in the literature. The investigator should be aware of all relevant new data on the product that appears during the course of the clinical trial.