Long Mean Time for Response to Queries

Long Mean Time for Response to Queries (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI NO
Therapeutic Area General
IF Risk-Event database can't be locked
DUE TO Risk Causes missing data in the CRF and opened Queries
THEN Risk Impact MAY RESULT delayed statistical analysis
Risk Indicator Long Mean Time for Response to Queries
Metric Mean number of days to respond to Queries
Unit Days
What level should be measured Site
Purpose A KRI checking whether the sites are always up-to-date with respect to answering queries generated by the EDC edit checks.
Description KRI monitors the time between a query generated by the EDC system edit checks and the response time needed by the site staff
Formula For all queries with known open date, select those what were replied or closed within past XXX days. For such queries calculate a number of days they were opened (if more than YYY days, consider YYY days). If the query is replied and closed, take the earlies of these dates. For all queries used in the open date calculation, calculate the mean value.
Suggested Thresholds - High >15 Days
Suggested Thresholds - Medium >10 Days
Associated Metric 1 Number of days to respond to queries
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