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5 Steps to Make Your Monitoring Efforts Matter

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Monitoring is defined by the FDA as the act of overseeing an investigation. The International Organization for Standardization and the International Conference on Harmonisation further define monitoring as “The act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this International Standard, and the applicable regulatory requirements” (ISO 14155:2011(E), 3.29; ICH E6 1.38).

What 5 steps can be taken to ensure monitoring goals are achieved?


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