Serious Adverse Events (SAE) Audit of an Oncology Clinical Trial
Clinical trials are the cornerstone of the development of new medicines. The safety profile of an investigational medicinal product (IMP) is only as reliable as the clinical studies carried out during its development; particularly through the reporting of adverse events (AE) and serious adverse events (SAE) during the Phase II and III clinical studies. All AEs and SAEs are collected during a clinical trial to ensure patient safety and monitor the safety profile of the IMP. Nicola McElroy of Quintiles outlines the audit of an oncology clinical trial.
http://jforcs.com/jcs/wp-content/uploads/2013/04/Serious-Adverse-Events-SAE-Audit-of-an-Oncology-Clinical-Trial.pdf