- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5.11 Quality assurance
The sponsor should establish a system or systems of quality assurance (including independent auditing) to ensure that the conduct of the clinical trial and the generation, documentation, and reporting of data comply with the protocol, Good Clinical Practice standards and applicable regulatory requirements. The system should operate independently of those involved in conducting or monitoring the trial (see Section 12).