- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
The sponsor is responsible for implementing a system of quality assurance in order to ensure that the trial is performed and the data are generated, recorded, and reported in compliance with the protocol, Good Clinical Practice, and national regulations.
All clinical trial sites, data and documents must be available for verification. All observations and findings should be verifiable in order to ensure the credibility of data and to assure that the conclusions presented are derived correctly from the raw data. The verification processes must be specified and scientifically justified. Statistically controlled sampling may be used to verify data in a trial.
Quality control procedures must be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
The sponsor, investigational sites, facilities and laboratories, and all relevant data (including raw data) and documentation and reports concerning the data (including subject files) must be available for an audit and for inspection by relevant health authorities. The audit should be conducted by a nominated person(s) or organization(s) independent of those carrying out the clinical trial.