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 sponsor/CRO 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