Q1: Please list regular inspection activities during a Clinical Trial?
The main objectives for the inspection of clinical trials is to ensure that the generally accepted principles of good clinical practices are met, validate the quality of the data generated, and verify compliance to Division 5 of the Regulations.
Sponsors, Qualified Investigators, Contract Research Organizations and Site Management Organizations will be inspected.
The total number of inspections may vary depending on the time required for investigations.
Two types of inspections will be performed:
1. Inspection during clinical trials, and
2. Inspection after the completion of clinical trials.
The choice of inspection sites will be reviewed periodically in consultation with the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) of the HPFB and will take into consideration:
1. The level of risk to the enrolled subjects, and
2. The observations made during past inspections.
Compliance will be assessed in accordance with Division 5 of the Food and Drug Regulations, Good Clinical Practices (GCP) and other pertinent guidelines.
Following are the list regular inspection activities during a Clinical Trial:
Opening Meeting to confirm purpose of inspection, provide introductions and methodology.
Combination of staff interviews, document review and facility visits.
Finding missing elements,inconsistencies with protocol, Forms not updated with amendments, Poor version control, Incorrect form used and unclear process.
Use study specific examples to demonstrate the system.
Feedback of general findings at closing meeting.