High Percentage of Failed ePRO Devices
| Type of indicator | Risk |
|---|---|
| Risk Category | Technology |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Electronic Patient-Reported Outcome (ePRO) devices or subjects’ own devices fail or malfunction. |
| DUE TO Risk Causes | Hardware malfunctions, software issues, connectivity problems, or user misunderstanding in completing ePRO entries. |
| THEN Risk Impact MAY RESULT | Incomplete or missing subject-reported data, potentially affecting study data integrity and delaying analysis or decision-making. |
| Risk Indicator | High Percentage of Failed ePRO Devices |
| Metric | Percentage of ePRO Devices that Failed or Experienced Malfunctions |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | Ensure continuous and reliable collection of subject-reported data using ePRO devices. Detect systemic technical issues early to minimize data loss and maintain study data quality and reliability. |
| Description | This KRI tracks the proportion of ePRO devices that fail or malfunction during data collection. It helps identify technical, logistical, or usability issues that could compromise subject-reported outcomes and study data completeness. |
| Formula | Calculate the percentage of ePRO devices that failed or malfunctioned: Failed ePRO Devices (%) = (Number of Subjects with Device Failures / Number of Enrolled Subjects) × 100 |
| Suggested Thresholds - High | 5% |
| Suggested Thresholds - Medium | 3% |
| Associated Metric 1 | Number of Enrolled Subjects |
| Associated Metric 2 | Number of Subjects Experiencing ePRO Device Failures |