High Percentage of Unverified Queries

High Percentage of Unverified Queries (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event the monitors do not confirm the responses to Queries in time
DUE TO Risk Causes lack of resources or other reasons
THEN Risk Impact MAY RESULT a delay in database lock and the study completion
Risk Indicator High Percentage of Unverified Queries
Metric Percent of unverified Queries
Unit %
What level should be measured Study/Country/Site
Purpose To measure a site monitor performance. Provides an insight into whether queries are open because they have not been responded to by sites or because they have not been closed by the sponsor/CRO.
Description KRI monitors the proportion of queries that have not yet been closed out of those that have been responded to by a site(s)
Formula Divide a number of responded but not closed queries by a number of replied queries for the same date and multiply by 100%.
Suggested Thresholds - High >20 %
Suggested Thresholds - Medium >10 %
Associated Metric 1 Number of responded queries (only answered but not confirmed yet)
Associated Metric 2 Number of Manual Queries
Associated Metric 3 Number of Automatic Queries
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