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 | |