Discrepancy b/w Locals and Central Labs Data

Discrepancy b/w Locals and Central Labs Data (kri)
Type of indicator Risk
Risk Category operational complexity
Golden KRI NO
Therapeutic Area General
IF Risk-Event local labs and central labs are used simultaneously for the study
DUE TO Risk Causes an urgent need of access to certain lab parameters
THEN Risk Impact MAY RESULT discrepancies in the results or difficulties in their interpretation
Risk Indicator Discrepancy b/w Locals and Central Labs Data
Metric Percent of discrepancies b/w local and central labs
Unit %
What level should be measured Study, Country, Site
Comments Secondary prio KRI
Purpose Ensure data accuracy and consistency across different laboratories, promoting reliable study findings and informed clinical decision-making.
Description KRI monitors inconsistencies or discrepancies between data from local and central laboratories, ensuring data accuracy and reliability in clinical trials or healthcare settings.
Formula Calculate number of data points what were analyzed by local AND central Labs, understand in what cases Central and Local Labs had diferent references - Number of data points compared where comparison was failed. Devide a number of instances of data discrepancies between local and central labs by a total number of data points compared, multiply by 100%
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of data points compared
Associated Metric 2 Number of data points compared where comparison was failed
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