Last Updated on February 22, 2022
An inspection or audit of Clinical Trial Site and or Clinical Trial Studies may be conducted by the Experts nominated by the Clinical Studies Committee (CSC) or DRAP. The aim is to evaluate the acceptability of clinical data submitted to DRAP, and to ensure compliance to the Good Clinical Practice (GCP) principles and practices as elaborated in the latest version of ICH-GCP Guidelines and the Bio-Study Rules, 2017.
The scope of GCP Inspections may extends to:
- The facilities and staff used for the trial: as approved by the Clinical Studies Committee (CSC) under the Bio-Study Rules 2017.
- Compliance with the approved Protocol.
- All amendments to the Protocol, which may have been approved.
- Accurate, complete and current records according to the Protocol.
- Verifying that Serious Adverse Events are reported as required by the Protocol.
- Verifying those inspections intended to monitor and audit the trials are conducted as required by the Protocol and the reports are available for inspection.