High Percentage of IMP Supply Issues

High Percentage of IMP Supply Issues (kri)
Type of indicator Risk
Risk Category IMP supply chain
Golden KRI NO
Therapeutic Area General
IF Risk-Event the investigational product supply is impaired
DUE TO Risk Causes a warehouse, customs or shipping company problem
THEN Risk Impact MAY RESULT an interruption of the study or a delay in the study completion
Risk Indicator High Percentage of IMP Supply Issues
Metric Percent of Sites with IMP Supply Issues
Unit %
What level should be measured Study, Country
Purpose Minimize the occurrence and impact of IMP supply issues on the study's timeline, data quality, and Subject welfare.
Description Monitors the proportion of supply issues related to Investigational Medicinal Products, enabling proactive management and mitigation of risks in clinical trials or research studies.
Formula Calculate sites what faced IMP issues (non availability within XXX days) within latest YYY days. Devide a number of sites with IMP issues by a total number of sites and multiply by 100%.
Suggested Thresholds - High >4 %
Suggested Thresholds - Medium >2 %
Associated Metric 1 Number of Sites
Associated Metric 2 Number of Sites with IMP issues
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