Monitoring
In Oversight, quality & inspection
Monitoring is the sponsor's ongoing check that a trial is being run according to the protocol, GCP, and the applicable regulations. It confirms that participants' rights and safety are protected and that reported data is accurate, complete, and verifiable. It combines visits to sites, remote document review, and central review of the incoming data.
Why it matters
Monitoring is the sponsor's main day-to-day control over trial quality, and its findings are what an inspector reads to judge whether the sponsor was paying attention.
Example
A central review flags that one site enrolls far faster than any other. The monitor schedules an unplanned visit and finds screening tests being repeated until a participant qualifies.
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