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Computerized systems and electronic data management have been embedded into clinical research at a rapid pace in all kinds of applications. Sometimes, this progress seems hardly noticeable. Many of the users of these computerized systems in clinical research environments are aware of the importance for data quality and integrity. However, 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 book, Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts, 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. Proper validation and use of computerized systems will help ensure the safety of subjects and the credibility of clinical research data.

The second edition of Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance 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. It provides the most-up-to-date information on: Computerized systems life cycle; security and integrity of GLP systems and records; and important concepts and trends in the use of computer networks and computerized instruments and equipment in the GLP environment.