Study Status

Nickname Protocol Nickname
Status Active
Site Activation 176 / 190 (92.6%)
Participant Enrollment 1301 / 1300 (100.1%)

Study Overview

21 Red KRIs
71 Amber KRIs

Summary Charts

Group Overview

As of 2025-03-18, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 92 Site-KRI combinations have been flagged across 67 sites as shown in the Study Overview Table above.
  • 15 sites have at least one red KRI
  • 67 sites have at least one red or amber KRI
  • 109 sites have neither red nor amber KRIs

Results

Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 400 24166 0.02 6.55
0X024 (Rinard) 7 83 4736 0.02 3.14
0X027 (Owens) 10 114 7957 0.01 3.04
0X090 (el-Attar) 1 17 475 0.04 2.44
0X054 (Vargas Padilla) 2 35 1647 0.02 2.40
0X041 (Yazzie) 3 39 2034 0.02 2.33
0X169 (Kanack) 3 42 2406 0.02 2.23
0X175 (Gonzalez) 16 129 12408 0.01 2.21
0X153 (Voss) 28 25 20902 0.00 -1.96
0X126 (Torres) 20 8 13774 0.00 -1.85
0X163 (el-Vaziri) 28 42 22818 0.00 -1.69
0X124 (Salas Dominguez) 27 36 20748 0.00 -1.67
0X161 (Vangoey) 69 148 50949 0.00 -1.66
0X003 (Drake) 13 5 10519 0.00 -1.66
0X080 (el-Mousa) 17 19 13479 0.00 -1.48
0X122 (el-Salameh) 17 24 13320 0.00 -1.31
0X180 (Tran) 12 13 9602 0.00 -1.27
0X157 (Arellano) 9 6 6832 0.00 -1.21
0X026 (el-Samra) 15 18 10653 0.00 -1.21
0X125 (Pond) 10 11 7803 0.00 -1.13
0X043 (Ford) 5 0 3779 0.00 -1.10
0X178 (Kessenich) 11 12 7627 0.00 -1.06
0X106 (Hill) 5 1 3536 0.00 -1.00


Serious Adverse Event Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 10 2286 0 10.10
0X109 (Nguyen) 1 2 715 0 3.54
0X131 (Tran) 1 1 441 0 2.23
0X021 (Lee) 4 3 3387 0 2.16
0X090 (el-Attar) 1 1 475 0 2.14


Non-Important Protocol Deviation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X124 (Salas Dominguez) 27 223 20748 0.01 4.18
0X155 (al-Sani) 4 55 2852 0.02 3.52
0X016 (el-Shaker) 7 74 4976 0.01 3.31
0X027 (Owens) 10 98 7957 0.01 3.19
0X026 (el-Samra) 15 111 10653 0.01 2.85
0X065 (Hill) 36 10 26286 0.00 -2.58
0X064 (al-Mussa) 5 44 3396 0.01 2.25
0X057 (Aragon) 6 54 4824 0.01 2.15


Important Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X124 (Salas Dominguez) 27 48 20748 0.00 5.96
0X064 (al-Mussa) 5 11 3396 0.00 3.64
X185X (Landry) 1 4 720 0.01 3.09
0X173 (el-Yusuf) 1 1 53 0.02 3.04
0X130 (Burroughs-Chock) 9 14 7678 0.00 2.65
0X027 (Owens) 10 14 7957 0.00 2.57
0X016 (el-Shaker) 7 10 4976 0.00 2.43
0X183 (Gray) 1 3 744 0.00 2.19
0X152 (Batchelder) 7 9 4966 0.00 2.12


Study Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X170 (Herlin) 4 3 4 0.75 3.58
0X011 (Gallegos) 5 3 5 0.60 3.09
0X103 (al-Mona) 5 3 5 0.60 3.09
0X022 (al-Nawaz) 3 2 3 0.67 2.71
0X037 (el-Mostafa) 3 2 3 0.67 2.71
0X152 (Batchelder) 7 3 7 0.43 2.42
0X077 (Gonzalez) 8 3 8 0.38 2.17


Treatment Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X103 (al-Mona) 5 4 5 0.80 4.38
0X011 (Gallegos) 5 3 5 0.60 3.15
0X022 (al-Nawaz) 3 2 3 0.67 2.76
0X037 (el-Mostafa) 3 2 3 0.67 2.76
0X152 (Batchelder) 7 3 7 0.43 2.48
0X170 (Herlin) 4 2 4 0.50 2.27
0X077 (Gonzalez) 8 3 8 0.38 2.23


Query Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X129 (Martinez) 10 420 18120 0.02 2.92
0X059 (Foster) 15 416 23484 0.02 -2.36
0X162 (Campa) 7 262 11375 0.02 2.21
0X043 (Ford) 5 124 7597 0.02 -2.17
0X075 (Dabit) 8 316 13957 0.02 2.13
0X171 (Hoffpauir) 12 462 20974 0.02 2.01
0X159 (Flores) 33 978 52327 0.02 -2.01
0X151 (Poveromo) 15 474 26102 0.02 -2.00


Delayed Query Resolution Rate

Summary Charts

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Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X002 (Biolchini) 1 5 30 0.17 5.00
0X118 (el-Dia) 2 6 87 0.07 2.88
0X087 (Vigo) 27 32 977 0.03 2.64
0X168 (Pinch) 3 6 98 0.06 2.58
0X162 (Campa) 7 11 262 0.04 2.29
0X081 (Hendee) 4 6 117 0.05 2.15
0X148 (Suess) 3 4 65 0.06 2.12
0X080 (el-Mousa) 17 3 579 0.01 -2.07
0X141 (Esquibel) 1 3 43 0.07 2.06


Delayed Data Entry Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 311 6123 0.05 3.03
0X143 (el-Salih) 8 46 1696 0.03 -2.88
0X171 (Hoffpauir) 12 134 2454 0.05 2.78
0X083 (el-Aman) 10 105 1913 0.05 2.52
0X085 (al-Mussa) 1 16 203 0.08 2.38
0X069 (Ello) 4 21 848 0.02 -2.35
0X029 (Truong) 4 45 749 0.06 2.23
0X186 (Gallegos-Neiberger) 2 25 379 0.07 2.11


Data Change Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X180 (Tran) 12 4923 19665 0.25 -3.25
0X089 (al-Nouri) 4 1699 6863 0.25 -2.49
0X088 (Correa) 11 4406 17468 0.25 -2.44
0X015 (Martinez) 3 1340 4897 0.27 2.41
0X005 (Arshad) 7 2912 11606 0.25 -2.35
0X139 (el-Khalifa) 2 812 2931 0.28 2.32
0X184 (Kapoor) 6 2776 10333 0.27 2.25
0X002 (Biolchini) 1 396 1658 0.24 -2.10


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold nMinDenominator Priority MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 0 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 0 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 0 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 0 Analysis_kri0004
Analysis kri0006 Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 0 Analysis_kri0006
Analysis kri0007 Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 0 Analysis_kri0007
Analysis kri0008 Site QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 Analysis_kri0008
Analysis kri0009 Site OQRY Delayed Query Resolution Rate Queries Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 Analysis_kri0009
Analysis kri0010 Site ODAT Delayed Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 Analysis_kri0010
Analysis kri0011 Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 Analysis_kri0011