- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
The monitor should be appropriately trained and fully aware of all aspects of the drug under investigation and the requirements of the protocol, including any annexes and amendments. The monitor should have adequate medical, pharmaceutical, and/or scientific qualifications, and clinical trial experience. The qualifications most appropriate for a monitor will depend on the type of trial and nature of the product under investigation.