Description
The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.
After a brief overview, the course consists of topics such as the following: closeout visit, essential documents, source document verification, CRF review, monitoring visit, fraud and scientific misconduct, and a key point summary at the end.
