Country KRI Overview

Study: AA-AA-000-0000

Study Status

Show Details

Description	Value
Participants Enrolled	1301
Sites Enrolled	176
Study Status	Active
protocol_row_id	1-1G9113
protocol_number	AA-AA-000-0000

Description	Value
Participants Enrolled	1301
Sites Enrolled	176
Study Status	Active
protocol_row_id	1-1G9113
protocol_number	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
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

Study Overview

0 Red KRIs

2 Amber KRIs

As of 2024-08-14, AA-AA-000-0000 has 1301 participants enrolled across 176 countries. 0 Site-KRI combinations have been flagged across 0 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
• 3 countries have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary

KRI Metric

KRI Score

Group	Enrolled	Numerator	Denominator	Metric	Score	Flag
China	257	880	199937	0	-1.19

Serious Adverse Event Rate

Summary Charts

Summary

KRI Metric

KRI Score

Group	Enrolled	Numerator	Denominator	Metric	Score	Flag
China	257	18	199937	0	-1.17

Non-Important Protocol Deviation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Important Protocol Deviation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Grade 3+ Lab Abnormality Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Study Discontinuation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Treatment Discontinuation Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Query Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Outstanding Query Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Outstanding Data Entry Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Data Change Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Screen Failure Rate

Summary Charts

Summary

KRI Metric

KRI Score

Nothing flagged for this KRI.

Metric Details

File	MetricID	GroupLevel	Abbreviation	Metric	Numerator	Denominator	Model	Type	Score	Threshold	nMinDenominator
cou0001.yaml	cou0001	Country	AE	Adverse Event Rate	Adverse Events	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-2,-1,2,3	30
cou0002.yaml	cou0002	Country	SAE	Serious Adverse Event Rate	Serious Adverse Events	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-2,-1,2,3	30
cou0003.yaml	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
cou0004.yaml	cou0004	Country	PD	Important Protocol Deviation Rate	Important Protocol Deviations	Days on Study	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30
cou0005.yaml	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
cou0006.yaml	cou0006	Country	SDSC	Study Discontinuation Rate	Subjects Discontinued - Study	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3
cou0007.yaml	cou0007	Country	TDSC	Treatment Discontinuation Rate	Subjects Discontinued - Treatment	Enrolled Subjects	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	3
cou0008.yaml	cou0008	Country	QRY	Query Rate	Queries	Total Data Points	Normal Approximation	rate	Adjusted Z-Score	-3,-2,2,3	30
cou0009.yaml	cou0009	Country	OQRY	Outstanding Query Rate	Queries Open > 30 Days	Total Queries	Normal Approximation	binary	Adjusted Z-Score	-3,-2,2,3	30
cou0010.yaml	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
cou0011.yaml	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
cou0012.yaml	cou0012	Country	SF	Screen Failure Rate	Screen Failures	Screened Subjects	Normal Approximation	binary	Adjusted Z-	-3,-2,2,3	3