High Percentage of Subjects with PDs of staging

High Percentage of Subjects with Protocol Deviations (PDs) for Staging

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
Parameter	%
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	Divide the number of Subjects with PDs related to staging by the 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