High Percentage of Subjects with PDs of grading

High Percentage of Subjects with Protocol Deviations (PDs) for Grading

Type of indicator	Performance
Risk Category	Subject Population
Golden KRI	No
Therapeutic Area	Oncology
IF Risk-Event	Subjects with incorrect grading are enrolled
DUE TO Risk Causes	Inaccurate histological assessment during screening, errors in enrollment processes
THEN Risk Impact MAY RESULT	Participant safety, rights and/or well-being might be impacted and/or data integrity might be affected leading to inability to use participant data
Risk Indicator	High percentage of subjects with protocol deviations for grading
Metric	Percent of enrolled subjects with PDs related to grading
Unit	%
What level should be measured	Study, Country, Site
Purpose	To detect systemic issues with the grading process during screening in order that actions can be put in place to minimize recurrence and impact on future trial participants and on the study data.
Description	This KRI monitors the proportion of subjects with protocol deviations related to grading. It alarms if this is higher than expected.
Formula	(Number of Subjects with One or More PDs Related to Grading)/(Number of Enrolled Subjects) x100. Use values from the same date.
Suggested Thresholds - High	>3 %
Suggested Thresholds - Medium	>2 %
Associated Metric 1	Number of Enrolled Subjects
Associated Metric 2	Number of Subjects with One or More PDs Related to Grading