High Percentage of Total Overdue Queries

High Percentage of Total Overdue Queries (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event a site doesn’t respond to Queries in timely fashion
DUE TO Risk Causes sloppiness
THEN Risk Impact MAY RESULT a delay for the database lock
Risk Indicator High Percentage of Total Overdue Queries
Metric Percent of Queries responded in more than XXX days of Query being posted
Unit %
What level should be measured Study/Country/Site
Comment Calculate only for closed Queries
Purpose To help assess the resoponsiveness of the site and CRA/DM (as applicable). A high level of overdue queries for the site may be due to poor site responsiveness and might indicate challenges at the site such as resource or training which might impact other aspects of the clinical trial. It may be due to the queries not being closed on time after responses from the site and so the level of unverified queries should also be assessed.
Description KRI monitors the proportion of queries that are overdue for closure (response from site and verification) out of all queries issued
Formula For all closed Queries understand delta between Query Open date and Query Close date, if delta is more than XXX days then consider as Overdue Query. Divide a value of metric Number of Overdue Queries by a value of Number of Queries for the same date and multiply by 100%.
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of Manual Queries
Associated Metric 2 Number of Automatic Queries
Associated Metric 3 Days to respond to Queries
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