Study Status

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

Study Overview

8 Red KRIs
50 Amber KRIs

Summary Charts

Site Overview

As of 2026-07-12, AA-AA-000-0000 has 760 participants enrolled across 148 sites. 58 Site-KRI combinations have been flagged across 43 sites as shown in the Study Overview Table above.
  • 7 sites have at least one red KRI
  • 43 sites have at least one red or amber KRI
  • 105 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

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Group Enrolled Numerator Denominator Metric Score Flag
16498 (Doe) 9 18 149 0.12 2.80
2392 (Deer) 11 9 497 0.02 -2.59
5960 (Doe) 7 14 125 0.11 2.23
14393 (Deer) 6 9 72 0.12 2.07
10624 (Smith) 4 1 110 0.01 -1.54
26880 (Deer) 7 9 324 0.03 -1.50
6452 (Smith) 4 8 67 0.12 1.84
24964 (Deer) 5 7 59 0.12 1.71
10388 (Doe) 5 5 39 0.13 1.59
17172 (Smith) 8 19 228 0.08 1.56
26115 (Smith) 9 31 411 0.08 1.56
20531 (Smith) 10 27 349 0.08 1.56
18548 (Doe) 7 15 171 0.09 1.54
12417 (Doe) 11 14 435 0.03 -1.43
37702 (Doe) 11 20 570 0.04 -1.41
33617 (Deer) 9 15 440 0.03 -1.31
17731 (Deer) 3 0 52 0.00 -1.28
18777 (Doe) 11 17 477 0.04 -1.25
5444 (Doe) 2 1 79 0.01 -1.20
9075 (Doe) 5 4 155 0.03 -1.12
22033 (Doe) 6 3 126 0.02 -1.09
30816 (Smith) 4 0 37 0.00 -1.08
10371 (Doe) 3 2 95 0.02 -1.04


Serious Adverse Event Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
2392 (Deer) 11 2 497 0.00 -2.47
16498 (Doe) 9 11 149 0.07 2.84
38166 (Doe) 4 4 42 0.10 2.19
25616 (Deer) 4 0 158 0.00 -1.64
10624 (Smith) 4 0 110 0.00 -1.37
26880 (Deer) 7 4 324 0.01 -1.26
30729 (Deer) 7 4 322 0.01 -1.25
9075 (Doe) 5 1 155 0.01 -1.23
16992 (Doe) 8 2 203 0.01 -1.17
5444 (Doe) 2 0 79 0.00 -1.16
17808 (Smith) 12 8 498 0.02 -1.15
38497 (Smith) 7 2 190 0.01 -1.09
12417 (Doe) 11 7 435 0.02 -1.07
18777 (Doe) 11 8 477 0.02 -1.05
38404 (Smith) 5 1 127 0.01 -1.04


Non-Important Protocol Deviation Rate

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Group Enrolled Numerator Denominator Metric Score Flag
38711 (Doe) 6 23 301 0.08 2.14


Important Protocol Deviation Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
30776 (Deer) 3 7 32 0.22 4.06


Grade 3+ Lab Abnormality Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
34071 (Smith) 6 45 2050 0.02 2.73
33296 (Smith) 6 43 2014 0.02 2.49
18548 (Doe) 7 34 1539 0.02 2.41
34 (Doe) 4 24 1037 0.02 2.25
26880 (Deer) 7 60 3110 0.02 2.18
25476 (Doe) 5 32 1510 0.02 2.11


Study Discontinuation Rate

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Nothing flagged for this KRI.


Treatment Discontinuation Rate

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Nothing flagged for this KRI.


Query Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
531 (Smith) 11 3854 10000 0.39 2.59
34071 (Smith) 6 1880 4000 0.47 2.52
32913 (Smith) 5 1128 2000 0.56 2.48
28689 (Deer) 6 1692 4000 0.42 2.03


Delayed Query Resolution Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
17731 (Deer) 3 181 188 0.96 2.29
30212 (Deer) 4 444 470 0.94 2.20


Delayed Data Entry Rate

Summary Charts

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Group Enrolled Numerator Denominator Metric Score Flag
37702 (Doe) 11 807 14664 0.06 2.83
38497 (Smith) 7 157 2632 0.06 2.36
6452 (Smith) 4 94 1504 0.06 2.33


Data Change Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
17444 (Smith) 2 565 2000 0.28 2.31
34660 (Smith) 4 1100 4000 0.28 2.14
18260 (Doe) 1 288 1000 0.29 2.05


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric Priority Flag RiskScoreWeight MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -1.5,-1,1.5,2 30 Denominator 0 -2,-1,0,1,2 32,16,0,1,2 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 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 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 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 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 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 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 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 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 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 Analysis_kri0011
Analysis srs0001 Site SRS Site Risk Score Weight Maximum Weights Identity identity Normalized Risk Score NA NA NA 4 NA NA Analysis_srs0001