- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5.13 Handling of adverse events
The sponsor should provide special forms for reporting any adverse event that occur during the clinical trial. The sponsor must investigate promptly, together with the investigator(s), all serious adverse events, take appropriate measures to ensure the safety of trial subjects, and report these events to appropriate authorities in accordance with applicable national requirements (see Section 7).