High Percentage of Subjects with PDs of grading

High Percentage of Subjects with PDs of grading (kri)
Type of indicator Performance
Risk Category subject population
Golden KRI NO
Therapeutic Area Oncology
IF Risk-Event subjects with incorrect grading are enrolled
DUE TO Risk Causes a poor histological assessment
THEN Risk Impact MAY RESULT a short survival of the enrolled subjects
Risk Indicator High Percentage of Subjects with PDs of grading
Metric Percent of Subjects with PDs related to grading
Unit %
What level should be measured Study, Country, Site
Purpose Ensure the accuracy and reliability of grading processes in clinical trials or research studies, thereby enhancing the validity of study outcomes and supporting unbiased data analysis.
Description KRI monitors the occurrence of a significant proportion of study participants experiencing protocol deviations specifically related to the grading or assessment of clinical parameters or endpoints, emphasizing the importance of consistent and accurate grading processes in clinical trials or research studies.
Formula Devide a number of Subjects with PDs related to grading by a number of enrolled Subjects, multiply by 100%.
Suggested Thresholds - High >3 %
Suggested Thresholds - Medium >2 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of Subjects with PDs related to grading
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