- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5.9 Compensation for subjects and investigators
As required by national law or regulations, the sponsor should provide adequate compensation or treatment for subjects in the event of trial-related injury or death, and provide indemnity for the investigator, except in the case of claims resulting from malpractice and/or negligence. (See Section 3.2 (e)-(f)).