High Percentage of Overdue Monitoring eCRF Pages (kri)
Type of indicator
Performance
Risk Category
Data Collection
Golden KRI
Yes
Therapeutic Area
General
IF Risk-Event
The eCRFs are not monitored regularly according to plan
DUE TO Risk Causes
Lack of resources or other reasons
THEN Risk Impact MAY RESULT
When nearing database lock it may cause a delay to database lock and to study timelines
Risk Indicator
High percentage of eCRF pages overdue for monitoring
Metric
Percent eCRF pages unmonitored within XXX days
Unit
%
What level should be measured
Study, Country, Site
Purpose
To identify for the study, countries and sites if too high a level of eCRF pages are unmonitored. Attention can then be focused on ensuring monitoring is done in a timely way and 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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