Clinical research informatics (CRI) is the application of informatics principles and techniques to support the spectrum of activities and business processes that instantiate clinical research. Informatics, defined generally as the intersection of information and computer science with a health-related discipline, has a foundation drawn from many well-established, theory-based disciplines, including computer science, library and information science, cognitive science, psychology, and sociology. The newly articulated yet fundamental theorem of informatics states that information technology should be used to enable humans to function and perform better together than humans alone, and so informatics is a source for supportive technologies and tools that enhance - but not replace - unreservedly human processes.

Section I: Contexts of Clinical Research Informatics.- Introduction to Clinical Research Informatics.- From Notations to Data: The Digital Transformation of Clinical Research.- Clinical Research Environment. - Statistical and Study Design Foundations of Clinical Research.- Informatics Approaches to Participant Recruitment.- The Evolving Role of Consumers.- Clinical Research in the Post-Genomic Era.- Section II: Data Management and Systems in Clinical Research.- Clinical Research Information Systems.- Study Protocol Representation.- Data Quality in Clinical Research.- Patient-Reported Outcome Data.- Biobanking Challenges and Informatics Opportunities.- Patient Registries.- Section III: Knowledge Representation and Discovery.- Knowledge Representation and Ontologies.- Non-hypothesis Driven Research: Data Mining and Knowledge Discovery.- Natural Language Processing, Electronic Health Records, and Clinical Research.- Section IV: The Future of Clinical Research, Health, and Clinical Research Informatics.- Data Sharing: Electronic Health Records and Research Interoperability.- Standards Development and the Future of Research Data Sources, Interoperability, and Exchange.- Pharmacovigilance.- Clinical Trials Registries and Results Databases.- Future Directions in Clinical Research Informatics.- Index.