High Percentage of Subjects with PDs of staging

High Percentage of Subjects with PDs of staging (kri)
Type of indicator Performance
Risk Category subject population
Golden KRI NO
Therapeutic Area Oncology
IF Risk-Event subjects with incorrect staging are enrolled
DUE TO Risk Causes a poor tumor, node, and metastases (TNM) classification
THEN Risk Impact MAY RESULT a short survival of the enrolled subjects
Risk Indicator High Percentage of Subjects with PDs of staging
Metric Percent of Subjects with PDs related to staging
Unit %
What level should be measured Study, Country, Site
Purpose Ensure the accuracy and reliability of disease staging processes in clinical trials or healthcare settings, thereby enhancing the validity of study outcomes and supporting appropriate Subject management.
Description KRI monitors the occurrence of a significant proportion of study participants experiencing protocol deviations specifically related to the staging or classification of disease severity or progression, emphasizing the importance of consistent and accurate staging processes in clinical trials or healthcare settings.
Formula Devide a number of Subjects with PDs related to staging 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 staging
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