Study Status

Nickname OAK-38
Status Active
Site Activation 145 / 150 (96.7%)
Participant Enrollment 764 / 1000 (76.4%)

Study Overview

58 Red KRIs
81 Amber KRIs

Summary Charts

Site Overview

As of 2025-04-01, AA-AA-000-0000 has 764 participants enrolled across 145 sites. 139 Site-KRI combinations have been flagged across 91 sites as shown in the Study Overview Table above.
  • 55 sites have at least one red KRI
  • 91 sites have at least one red or amber KRI
  • 56 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

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X3601 (Doe) 5 11 51 0.22 2.74
0X6603 (Smith) 4 31 236 0.13 2.14
0X7514 (Deer) 5 18 120 0.15 2.12
0X101 (Deer) 5 25 183 0.14 2.09
0X9346 (Doe) 9 21 422 0.05 -1.97
0X4264 (Deer) 9 17 339 0.05 -1.75
0X2005 (Deer) 5 2 89 0.02 -1.65
0X1750 (Smith) 6 13 267 0.05 -1.62
0X2901 (Doe) 5 10 216 0.05 -1.56
0X6865 (Smith) 3 1 64 0.02 -1.56
0X4485 (Doe) 11 33 537 0.06 -1.44
0X958 (Deer) 5 15 280 0.05 -1.42
0X554 (Deer) 3 4 110 0.04 -1.41
0X8764 (Smith) 3 7 154 0.05 -1.35
0X213 (Smith) 10 46 689 0.07 -1.23
0X3973 (Doe) 6 9 173 0.05 -1.18
0X9569 (Doe) 4 3 80 0.04 -1.18
0X4629 (Doe) 6 24 381 0.06 -1.13
0X2970 (Deer) 7 12 213 0.06 -1.12
0X9737 (Doe) 7 26 404 0.06 -1.08
0X187 (Smith) 6 8 151 0.05 -1.07
0X8274 (Smith) 4 1 40 0.03 -1.06
Time Series


Serious Adverse Event Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X7514 (Deer) 5 13 120 0.11 3.22
0X6248 (Smith) 2 5 35 0.14 2.65
0X3090 (Smith) 8 22 294 0.07 2.47
0X3601 (Doe) 5 6 51 0.12 2.40
0X9871 (Deer) 7 15 185 0.08 2.34
0X3301 (Deer) 3 5 40 0.12 2.33
0X101 (Deer) 5 14 183 0.08 2.05
0X9346 (Doe) 9 11 422 0.03 -1.53
0X8091 (Smith) 6 4 208 0.02 -1.51
0X2005 (Deer) 5 1 89 0.01 -1.33
0X958 (Deer) 5 7 280 0.03 -1.32
0X4323 (Smith) 14 23 725 0.03 -1.32
0X787 (Deer) 7 4 183 0.02 -1.26
0X4535 (Doe) 7 6 243 0.02 -1.25
0X4338 (Doe) 4 0 43 0.00 -1.25
0X6369 (Doe) 4 4 180 0.02 -1.23
0X9737 (Doe) 7 12 404 0.03 -1.17
0X3973 (Doe) 6 4 173 0.02 -1.15
0X2558 (Smith) 2 0 33 0.00 -1.10
0X4264 (Deer) 9 10 339 0.03 -1.09
0X3292 (Smith) 2 0 32 0.00 -1.08
Time Series


Non-Important Protocol Deviation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X3601 (Doe) 5 7 51 0.14 2.57
0X1881 (Doe) 5 8 70 0.11 2.29
Time Series


Important Protocol Deviation Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X4338 (Doe) 4 7 43 0.16 3.19
0X3301 (Deer) 3 5 40 0.12 2.11
0X2532 (Doe) 6 22 308 0.07 2.03
Time Series


Grade 3+ Lab Abnormality Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X7155 (Doe) 6 66 3325 0.02 2.51
0X6603 (Smith) 4 153 8594 0.02 2.48
0X6304 (Smith) 9 152 8676 0.02 2.28
0X1321 (Deer) 6 43 2174 0.02 2.00
Time Series


Study Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X759 (Smith) 5 3 5 0.60 4.21
0X9858 (Doe) 9 4 9 0.44 3.95
0X9360 (Smith) 10 3 10 0.30 2.51
Time Series


Treatment Discontinuation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X213 (Smith) 10 6 10 0.60 4.97
0X9360 (Smith) 10 4 10 0.40 2.93
0X3909 (Smith) 7 3 7 0.43 2.70
Time Series


Query Rate

Summary Charts

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Metric Table

Nothing flagged for this KRI.

Time Series


Delayed Query Resolution Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X3989 (Smith) 10 1314 1410 0.93 2.05
Time Series


Delayed Data Entry Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X4535 (Doe) 7 252 4136 0.06 3.08
0X3848 (Smith) 8 262 4512 0.06 2.37
Time Series


Data Change Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X4272 (Deer) 4 1260 4512 0.28 2.88
0X8799 (Doe) 10 11605 43616 0.27 2.71
0X213 (Smith) 10 18259 69184 0.26 2.12
0X8244 (Smith) 2 833 3008 0.28 2.06
Time Series


Screen Failure Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X5497 (Doe) 2 4 6 0.67 2.57
0X8351 (Deer) 7 7 14 0.50 2.41
0X4840 (Doe) 3 4 7 0.57 2.16
Time Series


PK Collection Compliance Rate

Summary Charts

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Bar Chart
Metric Table

Nothing flagged for this KRI.

Time Series


Inclusion/Exclusion Violation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X9142 (Smith) 17 10 17 0.59 10
0X8633 (Smith) 13 9 13 0.69 9
0X4323 (Smith) 14 9 14 0.64 9
0X9346 (Doe) 9 7 9 0.78 7
0X213 (Smith) 10 7 10 0.70 7
0X2192 (Deer) 9 6 9 0.67 6
0X7011 (Deer) 9 6 9 0.67 6
0X2532 (Doe) 6 5 6 0.83 5
0X2970 (Deer) 7 5 7 0.71 5
0X3989 (Smith) 10 5 10 0.50 5
0X5384 (Smith) 13 5 13 0.38 5
0X1910 (Deer) 5 4 5 0.80 4
0X2005 (Deer) 5 4 5 0.80 4
0X187 (Smith) 6 4 6 0.67 4
0X1982 (Smith) 6 4 6 0.67 4
0X3289 (Deer) 6 4 6 0.67 4
0X4629 (Doe) 6 4 6 0.67 4
0X4959 (Doe) 7 4 7 0.57 4
0X7983 (Smith) 7 4 7 0.57 4
0X8517 (Smith) 7 4 7 0.57 4
0X3090 (Smith) 8 4 8 0.50 4
0X2170 (Deer) 9 4 9 0.44 4
0X4264 (Deer) 9 4 9 0.44 4
0X8625 (Deer) 9 4 9 0.44 4
0X8786 (Deer) 9 4 9 0.44 4
0X8788 (Deer) 10 4 10 0.40 4
0X8799 (Doe) 10 4 10 0.40 4
0X9580 (Deer) 12 4 12 0.33 4
0X9569 (Doe) 4 3 4 0.75 3
0X1881 (Doe) 5 3 5 0.60 3
0X3601 (Doe) 5 3 5 0.60 3
0X6665 (Smith) 5 3 5 0.60 3
0X759 (Smith) 5 3 5 0.60 3
0X8753 (Doe) 5 3 5 0.60 3
0X1321 (Deer) 6 3 6 0.50 3
0X1750 (Smith) 6 3 6 0.50 3
0X1856 (Smith) 6 3 6 0.50 3
0X4535 (Doe) 7 3 7 0.43 3
0X4541 (Deer) 7 3 7 0.43 3
0X787 (Deer) 7 3 7 0.43 3
0X8351 (Deer) 7 3 7 0.43 3
0X9871 (Deer) 7 3 7 0.43 3
0X3848 (Smith) 8 3 8 0.38 3
0X4590 (Smith) 8 3 8 0.38 3
0X5895 (Deer) 8 3 8 0.38 3
0X7680 (Smith) 8 3 8 0.38 3
0X4486 (Doe) 9 3 9 0.33 3
0X5033 (Smith) 9 3 9 0.33 3
0X6304 (Smith) 9 3 9 0.33 3
0X6405 (Doe) 9 3 9 0.33 3
0X9360 (Smith) 10 3 10 0.30 3
0X4485 (Doe) 11 3 11 0.27 3
0X7619 (Smith) 3 2 3 0.67 2
0X180 (Doe) 4 2 4 0.50 2
0X4338 (Doe) 4 2 4 0.50 2
0X4440 (Doe) 4 2 4 0.50 2
0X6369 (Doe) 4 2 4 0.50 2
0X6502 (Deer) 4 2 4 0.50 2
0X6603 (Smith) 4 2 4 0.50 2
0X6637 (Deer) 4 2 4 0.50 2
0X4056 (Doe) 5 2 5 0.40 2
0X4937 (Doe) 5 2 5 0.40 2
0X6829 (Deer) 5 2 5 0.40 2
0X7514 (Deer) 5 2 5 0.40 2
0X8513 (Smith) 5 2 5 0.40 2
0X8631 (Doe) 5 2 5 0.40 2
0X8953 (Doe) 5 2 5 0.40 2
0X240 (Doe) 6 2 6 0.33 2
0X8091 (Smith) 6 2 6 0.33 2
0X6605 (Deer) 7 2 7 0.29 2
0X4028 (Doe) 9 2 9 0.22 2
Time Series


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric Priority Flag RiskScoreWeight ScoreCol 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 32,16,0,1,2 NA 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 8,0,0,4,8 NA 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 8,4,0,8,16 NA 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 0,0,0,16,32 NA 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 0,1,2 NA 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 0,16,32 NA 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 0,16,32 NA 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 0,1,2 NA 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 0,1,2 NA 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 0,1,2 NA 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 0,1,2 NA 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 0,0,0,8,16 NA 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 Inclusion/Exclusion Violation Rate Number of subjects ineligible Number of subjects enrolled Identity (Numerator) identity Ineligible Participants 1.5,2.5 3 Denominator 0 0,1,2 0,8,16 Numerator NA NA Analysis_kri0014
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