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Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.
“Monitoring generally results in findings,” said Susan Devine, Senior Manager, Clinical Trials Support Unit, The Hospital for Sick Children, Toronto, Canada. “For example, clinical research in pediatric cancer is conducted in the real life clinical setting, therefore there are few reviews that will not result in deficiencies. An effective monitoring plan acts as the catalyst for change by identifying deficient areas.”
Ms. Devine was lead author on an article describing ways plan sponsors can adapt mandatory monitoring requirements to improve internal trial processes and results. An objective monitoring approach includes four key elements.
“An effective monitoring plan acts to continuously raise the bar of research excellence,” she said. “Objective internal monitoring allows a program to identify deficiencies, recognize opportunities for improvement, and measure success.”