High Percentage of Subjects with PDs related to in/exclusion criteria (kri)

High Percentage of Subjects with PDs related to In/Exclusion Criteria Table

High Percentage of Subjects with PDs related to In/Exclusion Criteria

Type of indicator	Performance
Risk Category	Organizational experience
Golden KRI	Yes
Therapeutic Area	General
IF Risk-Event	Trial participants are randomized into the study but do not meet the inclusion/exclusion criteria
DUE TO Risk Causes	Site not adhering to the protocol, errors in participant history, protocol complexity
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. Statistical analysis of the data might be impacted.
Risk Indicator	High percentage of subjects with protocol deviations related to in/exclusion criteria
Metric	Percent of subjects with one or more PDs related to in/exclusion criteria
Unit	%
What level should be measured	Study, Country, Site
Comments
Purpose	To detect whether there may be systemic issues with the screening process with participants being incorrectly enrolled leading to undue risk to those participants. At site level, it is an indicator of possible significant issues at site that need further investigation. At study level, it is an indicator of challenges in applying the inclusion/exclusion criteria and possible risk to the ability to draw a conclusion from the trial.
Description	This KRI monitors the proportion of participants being enrolled who do not meet the inclusion/exclusion criteria. It alarms if the level is higher than expected.
Formula	Number of randomized Subject with PDs in I/E Criteria divided by the total number of randomized Subjects, multiply by 100%.
Suggested Thresholds - High	>3 %
Suggested Thresholds - Medium	>2 %
Associated Metric 1	Number of randomized Subjects
Associated Metric 2	Number of randomized Subjects with min 1 PD of I/E Criteria