Validating clinical trial data reporting

Despite this, few regulations talk about data validation directly.

Instead, the regulations and guidances focus on requirements that the data handling systems must meet to ensure data quality and integrity.

From an ethical perspective, clinical data affect treatment decisions, which affect patient health, and the patient population in question is virtually all of the United States and a significant fraction of the rest of the world.

For both of these reasons, clinical data quality and integrity are critical.

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However, the validation process is complex and dependent on the data captured, business and regulatory concerns, the data management software used, and several other factors, so there are many possible variations and options.

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