1.5 Monitoring & Audit
MONITORING
IN CLINICAL TRIALS
PowerPoint presentation
PowerPoint presentation
HOW
TO PREPARE FOR A GCP INSPECTION
pdf-file
The
purpose of trial monitoring as defined in ICH GCP is to ensure that:
1. the rights and well-being of trial participants are protected
2. the reported trial data are accurate, complete, and verifiable from source documents
3. the conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with the applicable regulatory requirements.
The following document outlines monitoring procedures which can be used in clinical trials:
