Query volume. In Phase 1 oncology nearly every lab value and symptom can become a monitor query, and each one costs coordinator time and delays database lock. When the adverse event lands in the EDC with its CTCAE criterion, source sentence, rationale and attribution already attached, the material a monitor would ask for is already there. A pilot measures query volume against the site's own baseline, with EDC completeness, sponsor review turnaround and time to database lock as secondary measures. Together they translate into cost to deliver per study, which is how a sponsor compares CRO bids.
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