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 that are planned to be launched for the current date, understand site start-up delay (delta between planned and actual start-up dates, if actual start-up happened earlier than planned then delta is 0). Calculate the number of sites with delta more than XXX days, divide by the total number of sites that should be launched for the current date, multiply by 100%.
Suggested Thresholds - High
>20 %
Suggested Thresholds - Medium
>10 %
Associated Metric 1
Number of sites planned to be active
Associated Metric 2
Number of activated sites with XXX days delay
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