The investigational product is not available during resupply
DUE TO Risk Causes
Production, customs, expiry, late ordering or other supply issues
THEN Risk Impact MAY RESULT
Shortage of IP for treatment leading to enrollment delays and/or inability to follow protocol requirements for enrolled participants leading to a high rate of participant drop outs.
Risk Indicator
Delay in IP availability for resupply
Metric
Number of days between planned IP availability for a Subject(s) and actual availability for resupply
Unit
Days
What level should be measured
Patient,Site,Country
Purpose
Without IP on site, sites cannot continue the process of participant recruitment which may delay the overall study timelines. And they may not be able to provide IP to enrolled participants with potential impact on participant safety and well-being and withdrawal rates.
Description
This KRI monitors delays in providing Investigational Product (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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