- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.10 Serious adverse events/reactions
The investigator must take appropriate measures to ensure the safety of clinical trial subjects (see also Section 7). The investigator is also responsible for notifying (with documentation) the relevant health authorities, the sponsor and, when applicable, the ethics committee immediately in the case of serious adverse events or reactions, as governed by national regulations.