Country KRI Overview

Study: AA-AA-000-0000 (Protocol Nickname)

Study Status

Show Details

Nickname	Protocol Nickname
Study Status	Active

Protocol Row Id	1-1G9113
Studyid	AA-AA-000-0000
Protocol Title	Protocol Title
Nickname	Protocol Nickname
Protocol Type	Investigator Sponsored
Phase	P3
Num Plan Site	190
Num Site Actl	176
Est Fpfv	2003-01-01
Act Fpfv	2003-01-01
Est Lplv	2021-06-01
Act Lplv	2021-06-01
Est Lpfv	2020-06-01
Act Lpfv	2020-06-01
Study Status	Active
Num Plan Subj	1300
Num Enrolled Subj M	1301
Protocol Indication	Protocol Indication
Product	Product
Therapeutic Area	Therapeutic Area
Protocol Product Number	123
X Rbm Flg	Y
Participants Enrolled	50
Sites Enrolled	154

Study Overview

0 Red KRIs

1 Amber KRIs

Summary Charts

Group Overview

As of 2012-12-31, AA-AA-000-0000 has 50 participants enrolled across 3 countries. 1 Country-KRI combinations have been flagged across 1 countries as shown in the Study Overview Table above.

• 0 countries have at least one red KRI
• 1 countries have at least one red or amber KRI
• 2 countries have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary

KRI Metric

KRI Score

Metric Table

Group	Enrolled	Numerator	Denominator	Metric	Score	Flag
China	41	11865	213145	0.06	-1.37

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Serious Adverse Event Rate

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Summary

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Nothing flagged for this KRI.

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Non-Important Protocol Deviation Rate

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Summary

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Nothing flagged for this KRI.

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Important Protocol Deviation Rate

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Summary

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Nothing flagged for this KRI.

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Grade 3+ Lab Abnormality Rate

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Summary

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Nothing flagged for this KRI.

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Study Discontinuation Rate

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Summary

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Nothing flagged for this KRI.

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Treatment Discontinuation Rate

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Summary

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Nothing flagged for this KRI.

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Query Rate

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Summary

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Nothing flagged for this KRI.

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Outstanding Query Rate

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Summary

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Metric Table

Nothing flagged for this KRI.

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Outstanding Data Entry Rate

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Summary

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Metric Table

Nothing flagged for this KRI.

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Data Change Rate

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Summary

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Nothing flagged for this KRI.

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Screen Failure Rate

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Summary

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Metric Table

Nothing flagged for this KRI.

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Metric Details

Type	ID	GroupLevel	Abbreviation	Metric	Numerator	Denominator	Model	AnalysisType	Score	Threshold	nMinDenominator	Priority	Output	Name	Description	MetricID
Analysis	cou0001	Country	AE	Adverse Event Rate	Adverse Events	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-2,-1,2,3	30	0	NA	NA	NA	Analysis_cou0001
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	0	NA	NA	NA	Analysis_cou0002
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	0	NA	NA	NA	Analysis_cou0003
Analysis	cou0004	Country	PD	Important Protocol Deviation Rate	Important Protocol Deviations	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0004
Analysis	cou0005	Country	LB	Grade 3+ Lab Abnormality Rate	Grade 3+ Abnormal Labs Samples	Total Lab Samples	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0005
Analysis	cou0006	Country	SDSC	Study Discontinuation Rate	Subjects Discontinued - Study	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	0	NA	NA	NA	Analysis_cou0006
Analysis	cou0007	Country	TDSC	Treatment Discontinuation Rate	Subjects Discontinued - Treatment	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	0	NA	NA	NA	Analysis_cou0007
Analysis	cou0008	Country	QRY	Query Rate	Queries	Total Data Points	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0008
Analysis	cou0009	Country	OQRY	Outstanding Query Rate	Queries Open > 30 Days	Total Queries	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0009
Analysis	cou0010	Country	ODAT	Outstanding Data Entry Rate	Data Pages Entered > 10 Days	Total Data Pages	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0010
Analysis	cou0011	Country	CDAT	Data Change Rate	Data Points with 1+ Change	Total Data Points	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30	0	NA	NA	NA	Analysis_cou0011
Analysis	cou0012	Country	SF	Screen Failure Rate	Screen Failures	Screened Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3	0	NA	NA	NA	Analysis_cou0012