Set Up

This page provides a sample Country 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)
## here() starts at /home/runner/work/gsm.kri/gsm.kri
## Country Report
lCharts_country <- gsm.kri::MakeCharts(
  dfResults = gsm.core::reportingResults_country,
  dfGroups = gsm.core::reportingGroups_country,
  dfMetrics = gsm.core::reportingMetrics_country,
  dfBounds = gsm.core::reportingBounds_country
)
## 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

Report

Study Status

Nickname OAK-38
Status Active
Site Activation 143 / 150 (95.3%)
Participant Enrollment 762 / 1000 (76.2%)

Study Overview

6 Red KRIs
2 Amber KRIs

Summary Charts

Country Overview

As of 2025-04-01, AA-AA-000-0000 has 762 participants enrolled across 3 countries. 8 Country-KRI combinations have been flagged across 3 countries as shown in the Study Overview Table above.
  • 3 countries have at least one red KRI
  • 3 countries have at least one red or amber KRI
  • 0 countries 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
UK 208 647 7593 0.09 -1.36
Time Series


Serious Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
UK 208 96 7593 0.01 -1.35
Time Series


Non-Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Grade 3+ Lab Abnormality Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

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

Nothing flagged for this KRI.

Time Series


Delayed Data Entry Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Data Change Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Screen Failure Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table

Nothing flagged for this KRI.

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
US 309 125 309 0.40 125
Japan 245 90 245 0.37 90
UK 208 81 208 0.39 81
Time Series


Premature Death Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
US 309 4 309 0.01 4
Japan 245 3 245 0.01 3
UK 208 2 208 0.01 2
Time Series


Metric Details

Active Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric GenerateRiskSignal Priority Flag ScoreCol RiskScoreWeight nPropRate nNumDeviations MetricID
TRUE Analysis cou0001 Country AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator TRUE 0 NA NA NA NA NA Analysis_cou0001
TRUE Analysis cou0002 Country SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator TRUE 0 NA NA NA NA NA Analysis_cou0002
TRUE Analysis cou0003 Country 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 TRUE 0 NA NA NA NA NA Analysis_cou0003
TRUE Analysis cou0004 Country IPD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 Denominator TRUE 0 NA NA NA NA NA Analysis_cou0004
TRUE Analysis cou0005 Country LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation binary Adjusted Z-Score 2,3 10 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0005
TRUE Analysis cou0006 Country SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0006
TRUE Analysis cou0007 Country TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0007
TRUE Analysis cou0008 Country QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score 2,3 30 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0008
TRUE Analysis cou0009 Country OQRY Delayed Query Resolution Rate Queries That Were Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0009
TRUE Analysis cou0010 Country ODAT Delayed Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0010
TRUE Analysis cou0011 Country CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score 2,3 100 Numerator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0011
TRUE Analysis cou0012 Country SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator TRUE 0 NA NA NA NA NA Analysis_cou0012
TRUE Analysis cou0013 Country PK PK Collection Compliance Rate PK Samples Collected PK Samples Expected Identity identity PK Collection Compliance Rate 0.9,0.85 3 Difference TRUE 0 -2,-1,0 NA NA NA NA Analysis_cou0013
TRUE Analysis cou0014 Country IE Ineligibility Number of subjects ineligible Number of subjects enrolled Identity (Numerator) identity Ineligible Participants 1.5, 2.5 3 Denominator TRUE 0 0,1,2 Numerator 0,8,16 NA NA Analysis_cou0014
TRUE Analysis cou0015 Country DTH90 Premature Death Rate Deaths in First 90 Days Enrolled Subjects Identity identity Numerator 1,2 1 Denominator TRUE 0 0,1,2 NA NA NA NA Analysis_cou0015