High Percentage of Start-Up Delays

High Percentage of Start-Up Delays (kri)
Type of indicator Performance
Risk Category organizational experience
Golden KRI NO
Therapeutic Area General
IF Risk-Event a start-up delay occurs
DUE TO Risk Causes a delay (>XXX days than planned start up) in contract signing, local ethics committee approval or clinical trial management and investigational product availability
THEN Risk Impact MAY RESULT non-compliance with timelines and budget
Risk Indicator High Percentage of Start-Up Delays
Metric Percent of delayed Site start-up
Unit %
What level should be measured Study, Country
Purpose Ensure timely initiation of clinical trials or research studies, facilitating efficient recruitment of participants, adherence to study timelines, and the generation of high-quality data.
Description KRI monitors the occurrence of delays in the initiation and start-up of clinical trials or research studies, ensuring timely study implementation and efficient resource utilization.
Formula For the sites what are planned to be launched for the current date, understand site start-up delay (delta between planned and actual startup dates, if actual start-up happened earlier than planned than delta is 0). Calculate number of sites with delta more than XXX days, devide by total number of sites what should be launched for the current date, multiply by 100%.
Suggested Thresholds - High >20 %
Suggested Thresholds - Medium >10 %
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