Introduction -- Section I: Contexts of Clinical Research Informatics -- From Notations to Data: The Digital Transformation of Clinical Research -- The Clinical Research Environment -- Methodological 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 -- Laboratory Data -- Patient Registries -- Knowledge Representation and Discovery -- Section III: Knowledge Representation and Ontologies -- Non hypothesis-driven Research: Data Mining and Knowledge Discovery -- Natural Language Processing, Electronic Health Records, and Clinical Research -- The Future of Clinical Research, Health, and Clinical Research Informatics -- Data Governance -- 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.