High Percentage of High Risk Sites in a Study

High Percentage of High Risk Sites in a Study (kri)
Type of indicator Performance
Risk Category organizational experience
Golden KRI NO
Therapeutic Area General
IF Risk-Event the inclusion of the higher risk sites occurs
DUE TO Risk Causes a lack of experience, the sponsor's desire despite previous warnings or need of budget hospitals
THEN Risk Impact MAY RESULT non-compliance with timelines, budget and data quality
Risk Indicator High Percentage of High Risk Sites in a Study
Metric Percent of high risk sites
Unit %
What level should be measured Study, Country
Comments The KRI requires information of Site risk assessment from the previous studies.
Purpose Ensure the overall success of the study by identifying and managing high-risk sites, mitigating potential risks, and optimizing data quality and participant safety.
Description KRI monitors the proportion of sites classified as high-risk within a study, ensuring proactive management of potential challenges and risks to data quality and participant safety.
Formula Devide a number of high risk sites by a total number of initiated sites, multiply by 100%
Suggested Thresholds - High >20 %
Suggested Thresholds - Medium >15 %
Associated Metric 1 Number of Initiated Sites
Associated Metric 2 Number of High Risk Sites
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