The referral
A site, a date, and a statistical trace
This is what lands in the clinical operations channel and in the risk-based monitoring queue. It says which site, which measures, which day, and what the statistics behind it were. It exists so a human being decides where the next monitoring visit goes.
What this does not do
It does not determine misconduct. It does not conclude that data were fabricated. It does not unblind, and it never touches treatment assignment. It makes no clinical judgement about any participant, and it takes no action toward a site. It flags a site for human monitoring review, and that is the entire scope of the output.
🔴 Protocol deviation rate jumped +224%site=047 Groningen
Review
monitoring, not adjudication
Likely cause · Four independent measures at site 047 changed together across Aug 10 and 11, and nothing changed at the other sites or study-wide. Enrolment pace nearly tripled against its own prior history, deviations and queries rose with it, and the variance of reported continuous measurements fell to about a third of the study-wide spread. Increasing throughput with decreasing measurement spread is the combination worth a human look, because real measurements do not get quieter under load. This is a monitoring signal only. It does not determine whether anything improper occurred, it does not unblind, and it makes no clinical judgement about any participant.
- 1.Route site 047 to the next risk-based monitoring cycle for a targeted source data review.
- 2.Have data management re-check the Aug 10 onward CRF pages against source for the flagged measurements.
- 3.Confirm with the site whether staffing, equipment, or the recruitment path changed on or around Aug 10.
AcknowledgeFalse positiveCUSUM · q < 0.0001 · BH-corrected
🔴 Enrolments per site-week jumped +183%site=047 Groningen
Review
monitoring, not adjudication
Likely cause · Four independent measures at site 047 changed together across Aug 10 and 11, and nothing changed at the other sites or study-wide. Enrolment pace nearly tripled against its own prior history, deviations and queries rose with it, and the variance of reported continuous measurements fell to about a third of the study-wide spread. Increasing throughput with decreasing measurement spread is the combination worth a human look, because real measurements do not get quieter under load. This is a monitoring signal only. It does not determine whether anything improper occurred, it does not unblind, and it makes no clinical judgement about any participant.
- 1.Route site 047 to the next risk-based monitoring cycle for a targeted source data review.
- 2.Have data management re-check the Aug 10 onward CRF pages against source for the flagged measurements.
- 3.Confirm with the site whether staffing, equipment, or the recruitment path changed on or around Aug 10.
AcknowledgeFalse positiveCUSUM · q < 0.0001 · BH-corrected
The audit rule
Every referral carries the q-value and the detector trace that produced it, and every site that was tested and not referred is recorded too. An inspector asking why site 023 was never reviewed gets the same answer every time, from the record rather than from somebody’s memory.