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As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and reliable manner, the Investigational Product is being handled as per.
If the site does not enroll any patients or enrolment is stopped, regular monitoring visits will not be scheduled.
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With the protocol, you can make sure you protect the participants and collect the data. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. As depicted in the NIA Guidance on Clinical Trials, NIA is responsible for overseeing the data and safety monitoring of the clinical research it supports.
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