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Table 5 Characteristics of monitoring findings

From: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

   Total
   n %
Total Studies   43 100
Total Monitoring Visits   214 100
Findings
  Administrative 1367 46.2
Patient rights 1453 49.1
Patient safety 32 1.1
Laboratory/biol. specimen 70 2.3
Endpoint related data point: confirmation requested 36 1.2
Endpoint related data point: Data point changed 3 0.1
Total 2961 100
Average n findings/visit   13.8  
Studies with
  at least 1 administrative finding 43 100
at least 1 patient right finding 41 95.3
at least 1 patient safety finding 9 20.9
  1. Sum of findings by CTU monitors in total (number, %). Note: Findings which were resolved on-site between monitor and study staff and not documented in monitoring reports are not listed.