High Percentage of Incorrect Subject Randomization

High Percentage of Incorrect Subject Randomization (kri)
Type of indicator Risk
Risk Category technology
Golden KRI NO
Therapeutic Area General
IF Risk-Event improper randomization of Subjects by IXRS occurs
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT non-acceptance of the study by health authorities
Risk Indicator High Percentage of Incorrect Subject Randomization
Metric Percent of incorrectly randomized Subjects
Unit %
What level should be measured Study, Country, Site
Comments Require additional information from the customer: or each subject in isolation whether (s)he was incorrectly randomized.
Purpose Ensure the accuracy and reliability of Subject randomization in clinical trials or research studies, thereby enhancing the validity of study findings and supporting evidence-based decision-making.
Description KRI monitors the occurrence of incorrect randomization assignments in clinical trials or research studies, ensuring the accuracy and integrity of subject randomization for reliable study outcomes and data analysis.
Formula Find all Subjects who have erros in randomization (PD, randomization cross check, randomization logs), devide by total number of randomized Subjects, multiply by 100%.
Suggested Thresholds - High >2 %
Suggested Thresholds - Medium >0 %
Associated Metric 1 Number of randomized Subjects
Associated Metric 2 Number of Subjects with Randomization error
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