Delay in IP availability for Site Start-Up

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 a study hold due to non-enrolable Subjects
Risk Indicator Delay in IP availability for Site Start-Up
Metric Number of days elapsed between planned IP availability on Site and actual availability for Site start-up
Unit Days
What level should be measured Site
Purpose Manage the risk of delayed IP availability, assess its impact on study timelines and Subject recruitment, and take appropriate measures to ensure timely access to IP at study sites.
Description The KRI monitors delays in providing Investigational Products (IP) to study sites for timely site start-up in clinical trials.
Formula Calculate delta between planned site start-up date and actual site start-up date.
Suggested Thresholds - High >30 Days
Suggested Thresholds - Medium >15 Days
Do you like the KRI description? Thanks for the feedback There was a problem submitting your feedback. Please try again later.