More than 1 Batch of MD was Used in a Study

More than 1 Batch of MD was Used in a Study (kri)
Type of indicator Risk
Risk Category IMP supply chain
Golden KRI NO
Therapeutic Area Medical Devices
IF Risk-Event Medical Devices from different production batches are being used in the study
DUE TO Risk Causes e.g. a low number of Medical Devices produced per batch
THEN Risk Impact MAY RESULT different results based on the various batches used
Risk Indicator More than 1 Batch of MD was Used in a Study
Metric Number of device batches
Unit No.
What level should be measured Study
Purpose Minimize the impact of using multiple device batches on study results and ensure consistency in device performance. By effectively managing the risk of using more than one batch of medical devices, organizations can enhance data reliability, maintain Subject safety, and optimize the overall success of the study or research project.
Description KRI monitors the use of more than one batch of medical devices in a study, ensuring consistency and mitigating associated risks.
Formula Calculate number of medical device batches
Suggested Thresholds - High >1 No.
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