Adjudication committee members non-availability (General TA)

Adjudication Committee Members Non-Availability Table

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), metric should be calculated for a specific date (meeting)
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	Divide the actual number of attendees by the planned number of attendees minus 1, multiply by 100%. KRI fires when the 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