High Percentage of Unverified Queries

High Percentage of Unverified Queries
Type of indicator Performance
Risk Category Data Collection Procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event Monitors do not verify or confirm responses to queries in a timely manner
DUE TO Risk Causes Lack of monitoring resources, process inefficiencies, or delays in query review workflows
THEN Risk Impact MAY RESULT Delays in database lock, data cleaning, and overall study completion timelines
Risk Indicator High Percentage of Unverified Queries
Metric Percent of Unverified Queries
Unit %
What level should be measured Study, Country, Site
Purpose Evaluate sponsor or CRO performance in query management. This KRI provides insight into whether queries remain open due to unverified responses rather than lack of site action, helping identify potential bottlenecks in the monitoring and data verification process.
Description This KRI monitors the proportion of queries that have been responded to by sites but not yet verified or closed by the sponsor or CRO. A high percentage may indicate process delays or insufficient monitoring resources.
Formula (Number of Responded but Unverified Queries) / (Number of Responded Queries) × 100.
Suggested Thresholds - High 20%
Suggested Thresholds - Medium 10%
Associated Metric 1 Number of Responded Queries (Answered but Not Yet Verified)
Associated Metric 2 Number of Manual Queries
Associated Metric 3 Number of Automatic Queries
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