Long Mean Time for Data Entry
| Type of indicator | Risk, Performance |
|---|---|
| Risk Category | Data Collection Procedures |
| Golden KRI | YES |
| Therapeutic Area | General |
| IF Risk-Event | The time between a subject visit and corresponding data entry is too long |
| DUE TO Risk Causes | Lack of resources, high subject enrollment, competing priorities, or inefficient workflows |
| THEN Risk Impact MAY RESULT | Potential risks to subject safety and delays to database lock and study timelines |
| 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 | Currently measures entry of the visit date. A business calendar can be configured to use business days for tighter thresholds. Only scheduled visits are included. |
| Purpose | Ensure timely entry of visit data into the EDC to protect subject safety and avoid delays in database lock and availability of study results. |
| Description | This KRI monitors the mean number of days between the visit date recorded in the eCRF and the timestamp when that visit date is entered in the EDC audit log (scheduled visits only). It triggers an alert if the mean delay exceeds expected limits. |
| Formula | Select performed visits with a known visit date (VisitDate) and a known EDC entry timestamp for that visit date (VisitEdcEntryDate). From these, include visits entered into EDC within the last XXX days (Rolling Period Days; if set to 0, do not filter). For each included visit, compute the full days between VisitEdcEntryDate and VisitDate (call this KKK). If KKK > YYY days (Limit Not Introduced Days; if 0, do not cap), then set KKK = YYY. The metric is the mean of all KKK values. |
| Suggested Thresholds - High | > 7 days |
| Suggested Thresholds - Medium | > 5 days |
| Associated Metric 1 | Number of Performed Visits with Known Visit and Entry Dates (Included in Rolling Period) |
| Associated Metric 2 | Per-Visit Days from Visit to EDC Entry (KKK) |
| Associated Metric 3 | Rolling Period Days (XXX) |
| Associated Metric 4 | Limit Not Introduced Days (Cap YYY) |