Adjudication committee members non-availability (General TA)
| Type of indicator | Risk |
|---|---|
| Risk Category | Data Collection Procedures |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Adjudication committee members are unavailable when data requiring adjudication is ready for review. |
| DUE TO Risk Causes | Scheduling conflicts, competing priorities, or inadequate planning of adjudication meetings. |
| THEN Risk Impact MAY RESULT | Delays in adjudication decisions, potential continuation of ineffective or unsafe treatments for subjects, and overall study timeline delays. |
| Risk Indicator | Adjudication Committee Members Non-Availability |
| Metric | Percentage of Adjudication Committee Members Not Available |
| Unit | % |
| What level should be measured | Study |
| Comments | The calculation depends on availability of meeting attendance records (e.g., from committee meeting logs). Metric should be calculated for each scheduled meeting date. |
| Purpose | Ensure timely adjudication of study endpoints by monitoring member attendance and availability. Helps maintain study integrity, prevent delays in critical decision-making, and support reliable clinical outcomes. |
| Description | This KRI monitors the frequency of adjudication committee member non-availability during scheduled meetings. It triggers an alert when the proportion of unavailable members exceeds acceptable limits, potentially impacting adjudication timelines and data quality. |
| Formula | Calculate the percentage of unavailable adjudication committee members: (Planned Number of Attendees - Actual Number of Attendees) / Planned Number of Attendees × 100% |
| Suggested Thresholds - High | 50% |
| Suggested Thresholds - Medium | 30% |
| Associated Metric 1 | Number of Actual Attendees |
| Associated Metric 2 | Planned Number of Attendees |