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 -- 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 -- 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 -- 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

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