Study KRI Comparison Report
April 01, 2026
Study-Level KRI Analysis
Overview
This report presents Key Risk Indicators (KRIs) calculated at the study level compared against a portfolio comparison group.
| StudyID | MetricID | Latest Month | Latest Value |
|---|---|---|---|
| AA-2 | Analysis_kri0001 | 190 | 0.004 |
| AA-2 | Analysis_kri0002 | 190 | 0.000 |
| AA-2 | Analysis_kri0003 | 190 | 0.000 |
| AA-2 | Analysis_kri0004 | 190 | 0.000 |
| AA-2 | Analysis_kri0005 | 192 | 0.002 |
| AA-2 | Analysis_kri0006 | 174 | 0.079 |
| AA-2 | Analysis_kri0007 | 174 | 0.089 |
| AA-2 | Analysis_kri0008 | 190 | 0.020 |
| AA-2 | Analysis_kri0009 | 185 | 0.019 |
| AA-2 | Analysis_kri0010 | 189 | 0.042 |
| AA-2 | Analysis_kri0011 | 190 | 0.260 |
| AA-2 | Analysis_kri0012 | 169 | 0.530 |
| AA-2 | Analysis_kri0013 | 183 | 0.290 |
| AA-2 | Analysis_kri0014 | 167 | 0.023 |
Charts
Below are the KRI charts for each study-metric combination.
AA-2 - Adverse Event Rate per Days on Study
AA-2 - Serious Adverse Event Rate per Days on Study
AA-2 - Non-Important Protocol Deviation Rate
AA-2 - Important Protocol Deviation Rate
AA-2 - Grade 3+ Lab Abnormality Rate
AA-2 - Treatment Discontinuation Rate
AA-2 - Query Rate
AA-2 - Data Change Rate
AA-2 - Study Discontinuation Rate
AA-2 - Query Rate
AA-2 - Delayed Query Resolution Rate
AA-2 - Delayed Data Entry Rate
AA-2 - Screen Failure Rate
AA-2 - PK Collection Compliance Rate
AA-2 - Inclusion/Exclusion Violation Rate
Metrics Metadata
| Type | ID | GroupLevel | Abbreviation | Metric | Numerator | Denominator | Model | Score | AnalysisType | Threshold | AccrualThreshold | AccrualMetric | BootstrapReps | Priority | MetricID |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analysis | kri0001 | Site | AE | Adverse Event Rate per Days on Study | Adverse Events | Days on Study | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0001 |
| Analysis | kri0002 | Site | SAE | Serious Adverse Event Rate per Days on Study | Serious Adverse Events | Days on Study | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0002 |
| Analysis | kri0003 | Site | PD | Non-Important Protocol Deviation Rate | Non-Important Protocol Deviations | Days on Study | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0003 |
| Analysis | kri0004 | Site | IPD | Important Protocol Deviation Rate | Important Protocol Deviations | Days on Study | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0004 |
| Analysis | kri0005 | Site | LB | Grade 3+ Lab Abnormality Rate | Grade 3+ Abnormal Labs Samples | Total Lab Samples | Bootstrap CI | Bootstrap CI | rate | 0.95 | 100 | Denominator | 1000 | 0 | Analysis_kri0005 |
| Analysis | kri0006 | Site | SDSC | Study Discontinuation Rate | Subjects Discontinued - Study | Enrolled Subjects | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0006 |
| Analysis | kri0007 | Site | TDSC | Treatment Discontinuation Rate | Subjects Discontinued - Treatment | Enrolled Subjects | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0007 |
| Analysis | kri0008 | Site | QRY | Query Rate | Queries | Total Data Points | Bootstrap CI | Bootstrap CI | rate | 0.95 | 500 | Denominator | 1000 | 0 | Analysis_kri0008 |
| Analysis | kri0009 | Site | OQRY | Delayed Query Resolution Rate | Queries That Were Open > 30 Days | Total Queries | Bootstrap CI | Bootstrap CI | rate | 0.95 | 100 | Denominator | 1000 | 0 | Analysis_kri0009 |
| Analysis | kri0010 | Site | ODAT | Delayed Data Entry Rate | Data Pages Entered > 10 Days | Total Data Pages | Bootstrap CI | Bootstrap CI | rate | 0.95 | 100 | Denominator | 1000 | 0 | Analysis_kri0010 |
| Analysis | kri0011 | Site | CDAT | Data Change Rate | Data Points with 1+ Change | Total Data Points | Bootstrap CI | Bootstrap CI | rate | 0.95 | 500 | Denominator | 1000 | 0 | Analysis_kri0011 |
| Analysis | kri0012 | Site | SF | Screen Failure Rate | Screen Failures | Screened Subjects | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0012 |
| Analysis | kri0013 | Site | PK | PK Collection Compliance Rate | PK Samples Collected | PK Samples Expected | Bootstrap CI | Bootstrap CI | rate | 0.95 | 100 | Denominator | 1000 | 0 | Analysis_kri0013 |
| Analysis | kri0014 | Site | IE | Inclusion/Exclusion Violation Rate | Number of subjects ineligible | Enrolled Subjects | Bootstrap CI | Bootstrap CI | rate | 0.95 | 5 | Denominator | 1000 | 0 | Analysis_kri0014 |
Report generated by gsm.studykri package