Delay in IP availability for Subject treatment

Type of indicator Risk
Risk Category IMP supply chain
Golden KRI NO
Therapeutic Area General
IF Risk-Event the investigational product is not available
DUE TO Risk Causes production, customs or any other supply issues
THEN Risk Impact MAY RESULT high rate of Subject drop outs
Risk Indicator Delay in IP availability for Subject treatment
Metric Number of days elapsed between planned IP availability on Site and actual availability for Subject treatment
Unit Days
What level should be measured Site
Purpose Address the issue promptly by coordinating with relevant stakeholders, optimizing supply chain processes, or implementing contingency plans to mitigate the impact of delayed IP availability on Subject treatment.
Description KRI monitors delays in providing Investigational Products (IP) to Subjects for their scheduled treatment, ensuring timely access for optimal study outcomes.
Formula Delta between expected date when the IP should be available for Subject treatment and Actual date of the IP availability.
Suggested Thresholds - High >5 Days
Suggested Thresholds - Medium >2 Days
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