Regulations and guidances that do mention clinical data validation, or a part of the process, are listed below.
The general outline for data validation is listed below.
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.
The eight characteristics are: Data validation tests usually check the original, accurate, complete, and consistent aspects of the data.
From a business perspective, the data are how the FDA, other regulators, and business partners evaluate the worth of the product.
Disambiguation: Clinical data validation means checking clinical data for correctness and completeness.
Clinical database validation is making sure that clinical databases perform the functions required by regulations and guidances and is on another page.
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.
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.