- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
6.2 Assessment of the trial site
The monitor should assess the trial site prior to the clinical trial to ensure that the facilities (including laboratories, equipment and staff) are adequate, and that an adequate number of trial subjects is likely to be available for the duration of the trial. The monitor should also assess the trial site during and after the trial to ensure that the investigator complies with the protocol and that data are handled in accordance with the predetermined set of standard operating procedures (SOP).