Set Up

This page provides a sample Site KRI Report generated using the standard KRIs included in the gsm.kri package. Expand the “Setup” section below to see the code used to generate the report. Or scroll down for the standard KRI report output.

Setup
# Load libraries
library(gsm.core)
library(gsm.kri)
library(here)

## Site Report
lCharts <- gsm.kri::MakeCharts(
  dfResults = gsm.core::reportingResults,
  dfGroups = gsm.core::reportingGroups,
  dfMetrics = gsm.core::reportingMetrics,
  dfBounds = gsm.core::reportingBounds
)
## Parsed -2,-1,2,3 to numeric vector: -2, -1, 2, 3
## Parsed -2,-1,2,3 to numeric vector: -2, -1, 2, 3
## Parsed -3,-2,2,3 to numeric vector: -3, -2, 2, 3
## Parsed -3,-2,2,3 to numeric vector: -3, -2, 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed 2,3 to numeric vector: 2, 3
## Parsed -3,-2,2,3 to numeric vector: -3, -2, 2, 3
## MetricID not found in dfBounds. Please double check input data if intentional.
## Parsed 0.9,0.85 to numeric vector: 0.9, 0.85
## MetricID not found in dfBounds. Please double check input data if intentional.
## Parsed 1.5,2.5 to numeric vector: 1.5, 2.5
## MetricID not found in dfBounds. Please double check input data if intentional.
## Parsed 1,2 to numeric vector: 1, 2
## MetricID not found in dfBounds. Please double check input data if intentional.
## Warning: Warning: Failed to parse strThreshold ('NA') to a numeric vector.

Report

Study Status

Nickname OAK-38
Status Active
Site Activation 148 / 150 (98.7%)
Participant Enrollment 760 / 1000 (76%)

Study Overview

37 Red KRIs
94 Amber KRIs

Summary Charts

Site Overview

As of 2025-04-01, AA-AA-000-0000 has 760 participants enrolled across 148 sites. 131 Site-KRI combinations have been flagged across 90 sites as shown in the Study Overview Table above.
  • 36 sites have at least one red KRI
  • 90 sites have at least one red or amber KRI
  • 60 sites have neither red nor amber KRIs

Missing delta columns in dfResults: Flag_Change, Flag_Previous, Score_Change, Score_Previous, Numerator_Previous, Denominator_Previous, Metric_Previous . Not rendering list of newly changed flags.NULL

Results

Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X1748 (Doe) 7 26 125 0.21 3.22
0X7838 (Deer) 3 8 32 0.25 2.19
0X1544 (Doe) 2 1 79 0.01 -1.58
0X9346 (Doe) 11 35 570 0.06 -1.47
0X3081 (Doe) 11 26 435 0.06 -1.37
0X5611 (Doe) 6 5 126 0.04 -1.27
0X2373 (Doe) 5 7 155 0.05 -1.25
0X958 (Deer) 11 32 497 0.06 -1.22
0X8351 (Deer) 9 28 440 0.06 -1.18
0X8764 (Smith) 4 8 162 0.05 -1.15
0X5425 (Smith) 2 2 61 0.03 -1.02
0X4671 (Smith) 2 1 43 0.02 -1.00
0X8768 (Deer) 7 5 107 0.05 -1.00
Time Series


Serious Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X9516 (Doe) 4 6 42 0.14 2.53
0X1748 (Doe) 7 12 125 0.10 2.29
0X4072 (Doe) 9 13 149 0.09 2.08
0X2894 (Doe) 5 5 39 0.13 2.08
0X4323 (Smith) 14 22 753 0.03 -1.61
0X958 (Deer) 11 13 497 0.03 -1.58
0X1544 (Doe) 2 0 79 0.00 -1.55
0X2373 (Doe) 5 2 155 0.01 -1.53
0X3719 (Smith) 5 2 135 0.01 -1.34
0X6410 (Deer) 4 3 158 0.02 -1.25
0X1750 (Smith) 7 7 277 0.03 -1.24
0X4590 (Smith) 12 15 498 0.03 -1.23
0X3081 (Doe) 11 13 435 0.03 -1.17
0X2323 (Smith) 6 8 297 0.03 -1.17
0X213 (Smith) 11 23 699 0.03 -1.17
0X6900 (Deer) 7 9 324 0.03 -1.16
0X8633 (Smith) 6 9 319 0.03 -1.12
0X5289 (Doe) 1 0 36 0.00 -1.04
0X4155 (Doe) 2 0 35 0.00 -1.03
Time Series


Non-Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X9737 (Doe) 6 23 301 0.08 2.14
Time Series


Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X7838 (Deer) 3 7 32 0.22 4.06
Time Series


Grade 3+ Lab Abnormality Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X8210 (Smith) 6 122 6466 0.02 2.68
0X9661 (Smith) 7 136 7528 0.02 2.35
0X8517 (Smith) 6 186 10843 0.02 2.07
Time Series


Study Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Treatment Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Query Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Delayed Query Resolution Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X4543 (Deer) 3 181 188 0.96 2.29
0X7604 (Deer) 4 444 470 0.94 2.20
Time Series


Delayed Data Entry Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X9346 (Doe) 11 807 14664 0.06 2.83
0X9661 (Smith) 7 157 2632 0.06 2.36
0X1934 (Smith) 4 94 1504 0.06 2.33
Time Series


Data Change Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X6405 (Doe) 6 8443 31584 0.27 2.84
0X8616 (Smith) 1 431 1504 0.29 2.35
0X8997 (Smith) 5 1635 6016 0.27 2.04
Time Series


Screen Failure Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X101 (Deer) 2 5 7 0.71 2.85
0X7208 (Smith) 4 6 10 0.60 2.59
0X5289 (Doe) 1 3 4 0.75 2.32
0X9082 (Doe) 1 3 4 0.75 2.32
0X4874 (Doe) 7 7 14 0.50 2.21
0X8351 (Deer) 9 8 17 0.47 2.16
Time Series


PK Collection Compliance Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Ineligibility

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X9346 (Doe) 11 8 11 0.73 8
0X5895 (Deer) 9 6 9 0.67 6
0X958 (Deer) 11 6 11 0.55 6
0X8625 (Deer) 12 6 12 0.50 6
0X7011 (Deer) 6 5 6 0.83 5
0X7004 (Smith) 9 5 9 0.56 5
0X2170 (Deer) 10 5 10 0.50 5
0X4485 (Doe) 11 5 11 0.45 5
0X4959 (Doe) 11 5 11 0.45 5
0X9142 (Smith) 15 5 15 0.33 5
0X7184 (Smith) 5 4 5 0.80 4
0X1727 (Smith) 7 4 7 0.57 4
0X1748 (Doe) 7 4 7 0.57 4
0X5384 (Smith) 7 4 7 0.57 4
0X9360 (Smith) 9 4 9 0.44 4
0X5033 (Smith) 10 4 10 0.40 4
0X3081 (Doe) 11 4 11 0.36 4
0X8799 (Doe) 13 4 13 0.31 4
0X2192 (Deer) 14 4 14 0.29 4
0X3077 (Deer) 3 3 3 1.00 3
0X4264 (Deer) 5 3 5 0.60 3
0X6405 (Doe) 6 3 6 0.50 3
0X8633 (Smith) 6 3 6 0.50 3
0X3289 (Deer) 7 3 7 0.43 3
0X3353 (Smith) 7 3 7 0.43 3
0X3989 (Smith) 7 3 7 0.43 3
0X6900 (Deer) 7 3 7 0.43 3
0X9414 (Deer) 7 3 7 0.43 3
0X4260 (Doe) 8 3 8 0.38 3
0X4314 (Smith) 8 3 8 0.38 3
0X8786 (Deer) 8 3 8 0.38 3
0X8351 (Deer) 9 3 9 0.33 3
0X2532 (Doe) 11 3 11 0.27 3
0X7983 (Smith) 13 3 13 0.23 3
0X4323 (Smith) 14 3 14 0.21 3
0X2883 (Doe) 3 2 3 0.67 2
0X4543 (Deer) 3 2 3 0.67 2
0X022 (Doe) 4 2 4 0.50 2
0X2901 (Doe) 4 2 4 0.50 2
0X3754 (Deer) 4 2 4 0.50 2
0X3938 (Smith) 4 2 4 0.50 2
0X7208 (Smith) 4 2 4 0.50 2
0X8764 (Smith) 4 2 4 0.50 2
0X9516 (Doe) 4 2 4 0.50 2
0X1786 (Smith) 5 2 5 0.40 2
0X3090 (Smith) 5 2 5 0.40 2
0X3319 (Smith) 5 2 5 0.40 2
0X3719 (Smith) 5 2 5 0.40 2
0X6184 (Deer) 5 2 5 0.40 2
0X6384 (Doe) 5 2 5 0.40 2
0X7096 (Doe) 5 2 5 0.40 2
0X8091 (Smith) 5 2 5 0.40 2
0X8997 (Smith) 5 2 5 0.40 2
0X9580 (Deer) 5 2 5 0.40 2
0X9604 (Smith) 5 2 5 0.40 2
0X1233 (Deer) 6 2 6 0.33 2
0X2323 (Smith) 6 2 6 0.33 2
0X3839 (Deer) 6 2 6 0.33 2
0X759 (Smith) 6 2 6 0.33 2
0X8354 (Deer) 6 2 6 0.33 2
0X8517 (Smith) 6 2 6 0.33 2
0X9737 (Doe) 6 2 6 0.33 2
0X1750 (Smith) 7 2 7 0.29 2
0X3909 (Smith) 7 2 7 0.29 2
0X4629 (Doe) 7 2 7 0.29 2
0X4874 (Doe) 7 2 7 0.29 2
0X7809 (Deer) 7 2 7 0.29 2
0X8768 (Deer) 7 2 7 0.29 2
0X6603 (Smith) 9 2 9 0.22 2
0X213 (Smith) 11 2 11 0.18 2
0X4590 (Smith) 12 2 12 0.17 2
Time Series


Premature Death Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X2883 (Doe) 3 1 3 0.33 1
0X404 (Smith) 3 1 3 0.33 1
0X9516 (Doe) 4 1 4 0.25 1
0X8517 (Smith) 6 1 6 0.17 1
0X5384 (Smith) 7 1 7 0.14 1
0X5895 (Deer) 9 1 9 0.11 1
0X2532 (Doe) 11 1 11 0.09 1
0X8625 (Deer) 12 1 12 0.08 1
0X8799 (Doe) 13 1 13 0.08 1
Time Series


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric Priority Flag ScoreCol RiskScoreWeight nPropRate nNumDeviations MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator 0 -2,-1,0,1,2 NA 32,16,0,1,2 NA NA Analysis_kri0001
Analysis kri0002 Site SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator 0 -2,-1,0,1,2 NA 8,0,0,4,8 NA NA Analysis_kri0002
Analysis kri0003 Site PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 Denominator 0 -2,-1,0,1,2 NA 8,4,0,8,16 NA NA Analysis_kri0003
Analysis kri0004 Site IPD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 Denominator 0 -2,-1,0,1,2 NA 0,0,0,16,32 NA NA Analysis_kri0004
Analysis kri0005 Site LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation binary Adjusted Z-Score 2,3 10 Numerator 0 0,1,2 NA 0,1,2 NA NA Analysis_kri0005
Analysis kri0006 Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 NA 0,16,32 NA NA Analysis_kri0006
Analysis kri0007 Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 NA 0,16,32 NA NA Analysis_kri0007
Analysis kri0008 Site QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 NA 0,1,2 NA NA Analysis_kri0008
Analysis kri0009 Site OQRY Delayed Query Resolution Rate Queries That Were Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 NA 0,1,2 NA NA Analysis_kri0009
Analysis kri0010 Site ODAT Delayed Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 NA 0,1,2 NA NA Analysis_kri0010
Analysis kri0011 Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score 2,3 100 Numerator 0 0,1,2 NA 0,1,2 NA NA Analysis_kri0011
Analysis kri0012 Site SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator 0 -2,-1,0,1,2 NA 0,0,0,8,16 NA NA Analysis_kri0012
Analysis kri0013 Site PK PK Collection Compliance Rate PK Samples Collected PK Samples Expected Identity identity PK Collection Compliance Rate 0.9,0.85 3 Difference 0 -2,-1,0 NA NA NA NA Analysis_kri0013
Analysis kri0014 Site IE Ineligibility Number of subjects ineligible Number of subjects enrolled Identity (Numerator) identity Ineligible Participants 1.5,2.5 3 Denominator 0 0,1,2 Numerator 0,8,16 NA NA Analysis_kri0014
Analysis kri0015 Site DTH90 Premature Death Rate Deaths in First 90 Days Enrolled Subjects Identity identity Numerator 1,2 1 Denominator 0 0,1,2 NA 0,4,8 NA NA Analysis_kri0015
Analysis srs0001 Site SRS Site Risk Score Weight Maximum Weights Identity identity Normalized Risk Score NA NA NA 4 NA NA NA NA NA Analysis_srs0001