Long Mean Time for Response to Queries

Long Mean Time for Response to Queries (kri)

Type of indicator	Performance
Risk Category	Data Collection
Golden KRI	No
Therapeutic Area	General
IF Risk-Event	The time for the site to respond to queries is too long
DUE TO Risk Causes	Site not understanding queries, large quantity of site queries or lack of capable resources
THEN Risk Impact MAY RESULT	Delayed database lock and delay to study timelines
Risk Indicator	Mean time for response to queries longer than expected
Metric	Mean time between query issued and site response
Unit	Days
What level should be measured	Site
Purpose	A KRI checking if a site replies to queries (both manual and automatic) in line with expected timing
Description	This KRI monitors the mean time in days between a query generated by the EDC system edit checks OR manual queries and the reply by site staff.
Formula	For all queries with known open date, select those that were replied within past XXX days. For such queries, calculate the number of days they were not replied (KKK days). If KKK is more than YYY days, consider KKK days. For all selected queries, calculate the mean value of KKK.
Suggested Thresholds - High	>15 Days
Suggested Thresholds - Medium	>10 Days
Associated Metric 1	Number of days to respond to queries