Introduction to Clinical Research Informatics.- From Notations to Data: The Digital Transformation of Clinical Research.- Methodological Foundations of Clinical Research.- The Clinical Research Environment.- Biorepositories.- Study Protocol Representation.- Clinical Research Information Systems.- Public Policy Issues in Clinical Research Informatics.- Integrating EHR and Research.- Data Quality in Clinical Research.- Research Data Governance, Roles, and Infrastructure.- Informatics Approaches to Patient Recruitment.- Patient Registries for Clinical Research.- Managing clinical data/research data and phenotyping/cohort discovery.- Patient Reported Outcome Data.- Laboratory Data [New].- Molecular, Genetic and other -omic Data.- Data Sharing: Clinical Trials Registries, Results Databases, and Research Data Repositories.- Knowledge Representation and Ontologies.- Developing and Promoting Data Standards for Clinical Research.- Non-Hypothesis Driven Research: Data mining and knowledge Discovery.- Advancing Clinical Research through Natural Language Processing on Electronic Health Records: Traditional Machine Learning Meets Deep Learning.- Back to the Future: The Evolution of Pharmacovigilance in the Age of Digital Healthcare.- The Evolving Role of Consumers.- Research in Open Environments.- Research in Context of Learning Health Systems.