- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
11.1 General responsibilities
The national drug regulatory authority should ensure that the protocols for clinical trials are submitted in advance for review and are in accordance with existing national regulations. On the basis of its review of clinical trial protocols and/or reports, the regulatory authority may propose revisions or request additional data on a clinical trial or terminate a trial.
The drug regulatory authority should evaluate the adequacy of supervision of the trial by reviewing the monitor’s reports to the sponsor (see Section 6.9). In addition, the authority should be able to conduct on-site inspections of the reliability and quality of reported results.
National regulations should specify the procedures for reporting and handling cases of misconduct discovered in connection with clinical trials.