High Percentage of Overdue Monitoring eCRF Pages

High Percentage of Overdue Monitoring eCRF Pages (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event the eCRF are not monitored regularly according to plan
DUE TO Risk Causes lack of resources or other reasons
THEN Risk Impact MAY RESULT a delayed database lock
Risk Indicator High Percentage of Overdue Monitoring eCRF Pages
Metric Percent eCRF pages unmonitored within XXX days
Unit %
What level should be measured Study/Country/Site
Purpose Identify instances where the number of eCRF pages that remain unmonitored after data entry and query resolution exceeds an acceptable percent. By tracking and analyzing this key risk indicator, the organization can ensure that the monitoring activities are conducted within the expected timeframe and that data discrepancies or potential issues are addressed in a timely manner.
Description The metric calculates percent of eCRF pages unmonitored in the expected monitoring time window (XXX days) after the last data entry or query resolution.
Formula To determine the status of each CRF form (page), follow these steps: If a CRF is closed, identify the date of the last data entry or the most recent resolved query. Calculate the number of days it took to verify the CRF. If this duration exceeds a specified threshold of XXX days, consider the CRF as overdue. For open CRFs, check the date of the last modification and compare it to the current date. If the number of days since the last modification exceeds the threshold of XXX days, consider the CRF as overdue. To calculate percent of overdue CRFs: Once you have identified all the overdue CRFs, calculate the sum of their counts and divide it by the total number of CRFs. This will provide a summary of the percentage of CRFs that are overdue.
Suggested Thresholds - High >15 %
Suggested Thresholds - Medium >10 %
Associated Metric 1 eCRF entered
Associated Metric 2 eCRFs planned to be entered
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