Long Mean Time for Data Entry

Long Mean Time for Data Entry 
Type of indicator Performance
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event the time between Subject visit and data entry is too long
DUE TO Risk Causes lack of resources or high number of Subjects enrolled
THEN Risk Impact MAY RESULT Subject safety and database closure delay
Risk Indicator Long Mean Time for Data Entry
Metric Mean time between Subject visit and data entry
Unit Days
What level should be measured Site
Comments We currently control not any “data entry” but just entry of visit date. It is possible to configure business calendar (for a Study) and can use business days, so can have tighter thresholds. Only scheduled visits.
Purpose Delays in data entry into the data capture system may jeopardize the Subject's safety and / or have a negative impact on the time of database closure / availability of the study results
Description The KRI controls exceeding of the mean time difference in days between a date when a visit was entered into EDC according to the audit log and a date of a visit in eCRF (only for scheduled visits). It alarms if the calculated difference is too high.
Formula Select records for visit with a known visit date VisitDate and visit data entry date VisitEdcEntryDate (the time point when the visit date was introduced into EDC). From them, select the visits introduced into EDC in the last XXX days (the parameter “Rolling Period Days” default value; if that parameter is set to zero, there is no filtering by the entry date). For each of the visit calculate the number of full days between the visit data entry time and the visit time. If that difference is greater than a limit of YYY days (the parameter default value; if that parameter “Limit Not Introduced Days” is set to zero, there is no limit), it’s replaced with a number of YYY days. In order to find the metric value the mean of these numbers is calculated.
Suggested Thresholds - High >7 Days
Suggested Thresholds - Medium >5 Days
Associated Metric 1 Time between Subject visit and EDC data entry
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