Validating electronic source data in clinical trials
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.Audience: AIDS Institute clinical care guidelines are produced and disseminated to clinicians in New York who provide prevention services and medical care to people who are living with or at risk of acquiring HIV, HCV, STI and substance use disorders.If the published evidence in support of a particular recommendation is not sufficient, the group relies on collective best practices experience to develop a final statement.
From a business perspective, the data are how the FDA, other regulators, and business partners evaluate the worth of the product.The clinical trials industry relies heavily on paper-based source documents as the foundation for the collection of its clinical research data from human subjects and medical records.This focus on paper documents has been prevalent throughout the history of clinical trials conduct, even as computing solutions advanced throughout the past 20 years.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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