What is data validation, and why is it crucial in clinical trials?
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1 Answer
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Data validation is the process of checking clinical data for accuracy, completeness, and consistency. It uses a series of automated checks and manual reviews to identify errors and inconsistencies, such as impossible dates, out-of-range values, or missing information.
It is crucial because clean and accurate data is the foundation of a reliable clinical trial.
Inaccurate data can lead to incorrect conclusions about a drug's safety or effectiveness, which could have serious public health consequences. Data validation ensures the integrity of the study results and provides a solid basis for regulatory submission.
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