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 the data to be assessed is available but the adjudication board members cannot meet
DUE TO Risk Causes conflict of activities
THEN Risk Impact MAY RESULT an unnecessary continuation of not working or well working treatment of Subjects
Risk Indicator Adjudication committee members non-availability (General TA)
Metric Percentage of Adjudication committee members not available
Unit %
What level should be measured Study
Comments Depends on whether customers have such data (protocol of the committee meeting with attendance record)
Purpose Optimize the adjudication process, enhance study integrity, and maintain the scientific rigor of clinical trials. By effectively managing the risk of committee member non-availability, organizations can ensure the timely resolution of data discrepancies, minimize delays in study progress, and uphold the credibility of the trial results.
Description Monitors the instances when adjudication committee members are unavailable, ensuring timely resolution of critical study endpoints and data discrepancies.
Formula Devide an actual number of attendees by a planned number of attendees minus 1, multiply by 100%. KRI fires when actual number of attendees is too low.
Suggested Thresholds - High >50 %
Suggested Thresholds - Medium >30 %
Associated Metric 1 Number of attendees
Associated Metric 2 Planned Number of attendees
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