- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.12 Monitoring, auditing and inspection
The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accept the implications of such visits (see also Section 6). In addition, the investigator must accept auditing and/or inspection by the relevant health authorities and by persons appointed by the sponsor for quality assurance.