Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts.
The clinical research community often underestimates the impact the use of electronic applications and computerized systems as well as the transmission of subject data may bring to the quality and integrity of data and the impact it may have on subject safety. This text applies and further develops the standards set forth through the Red Apple II GLP DIA initiative. This initiative is intended to set a benchmark for requirements of computerized systems used in clinical research. It is simultaneously intended to support the many users struggling to implement validation processes into clinical research, thus stimulating innovation in the clinical research environment.
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Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance.
This second edition explores the current environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.
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