Discrepancy b/w Locals and Central Labs Data

Discrepancy between Local and Central Labs Data

Type of indicator	Risk
Risk Category	Operational Complexity
Golden KRI	No
Therapeutic Area	General
IF Risk-Event	There are discrepancies in results between local and central lab data
DUE TO Risk Causes	Local and central labs being used for identical measurements (perhaps due to an urgent need of access to certain lab parameters)
THEN Risk Impact MAY RESULT	Challenges in interpretation of results and ability to make the correct clinical decisions leading to risks to participant safety and reliability of study data and conclusions
Risk Indicator	Discrepancy between local and central lab data
Metric	Percent of discrepancies between local and central lab data
Unit	%
What level should be measured	Study, Country, Site
Comments
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 that were analyzed by local AND central Labs, understand in what cases Central and Local Labs had different values/results - Number of data points compared where comparison was failed. Divide the number of instances of data discrepancies between local and central labs by the 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