Delayed Data Entry Rate

This KRI flags sites and countries with a high proportion of forms that were entered >10 days after the associated visit, relative to the overall total number of forms entered by the site/country.

Steps to Perform the Review

  1. In the KRI Report by Site, review the Outstanding Data Entry Rate scatter plot for outlier sites in red.

    Here site 30866 has entered 71% of all forms more than 10 days after the associated visit was performed; for this study data entry is expected in 2 days per eCRF Guidelines.

    High Outliers: this indicates the site is either unable to meet data entry requirements or is failing to do so for some other non-compliant reason. The volume of forms is also meaningful and the trend over time (e.g., has there been recent improvement).

    Low Outliers: not an issue in this KRI.

    Delayed data entry scatter plot

Investigate Signals

  1. Review the eCRF Guidelines to confirm the expected data entry timeline. Compare the observed average entry time.

  2. Review if the trend is worsening, no change, or if there has been any improvement via the Time Series timeline.

    Here you can see the trend has been worsening over the past 3 months.

    Delayed data entry trend