High Percentage of overall PDs (kri)

High Percentage of overall PDs (kri)
Type of indicator Performance
Risk Category organizational experience
Golden KRI NO
Therapeutic Area General
IF Risk-Event a site is not adhering to the protocol
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT difficulties for the statistical analytics and jeopardy of data usability
Risk Indicator High Percentage of overall PDs
Metric Rate of PD per Visit
Unit PD per visit
What level should be measured Study, Country, Site
Purpose Ensure adherence to study protocols, maintain data integrity, and uphold ethical and regulatory standards in clinical trials or research studies.
Description KRI monitors the proportion of protocol deviations (PDs) occurring in clinical trials or research studies, ensuring adherence to study protocols and data integrity.
Formula Divide a value of metric Number of PD by a value of metric Number of Visits for the same date.
Suggested Thresholds - High >3 PD per visit
Suggested Thresholds - Medium >2 PD per visit
Associated Metric 1 Number of PDs
Associated Metric 2 Number of Visists
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