UC-413
Protocol Deviation and Site Risk Triage
Reads site source data, deviation logs and monitoring visit reports, scores every site on risk, and sets the next monitoring visit order.
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The Challenge
Sites are monitored on a fixed calendar, so deviations surface months later and cost re-work at database lock. Trial data sits in the EDC, the CTMS and visit reports that nobody reads together.
How It Works
- Reads EDC listings, CTMS site records, monitoring visit reports and the protocol.
- Clusters deviations by type and site and scores sites against protocol-critical data.
- Issues a ranked site list and a drafted visit agenda to the clinical operations lead each week.
What It Removes
- Fixed-calendar visits to sites with no open findings
- Manual trawling of EDC listings for deviations
- Re-keying visit findings into the deviation log
Input Data RequirementsEDC exports, CTMS site records, monitoring visit reports, protocol and amendments, deviation and CAPA log, site delegation logs
Output FormatWeekly ranked site-risk list, drafted monitoring visit agenda, deviation register with a source citation behind every finding
“We monitor on a calendar, not on risk, so we find the same deviation at three sites six months apart”