Clinical Research Informatics

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Drs. Richesson and Andrews work with a data centre that supports a variety of diseases in the Pediatric Epidemiology Centre at the University of South Florida. Dr. Richesson has a very broad training on standards and wrote the first published journal article on the topic of data standards in clinical research. Dr. Andrews is a tenured professor in Information Science and has published several articles in leading journals in clinical research informatics.

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. Clinical Research Informatics contributes to the ongoing dialogues among researchers and practitioners in CRI as they continue to rise to the challenges of a dynamic and evolving clinical research environment. The development of CRI as a sub-discipline of informatics, and as an independent/maturing professional practice area in its own right, drives a growing pool of scientific literature based on original CRI research, and high-impact tools and systems will be developed. CRI leaders and stakeholder groups will continue to support and create communities of discourse that will address much needed practice standards in CRI, improved safety and efficiencies in clinical research, data standards in clinical research, policy issues, educational standards and instructional resources. The Editors and contributors to this book are among the most active and engaged in the CRI domain and provide an excellent primer for deeper explorations into this emerging discipline. Certain themes are highlighted, including the changing role of the consumer, movement toward transparency, growing needs for global coordination and cooperation on many levels, and the merging together of clinical care delivery and research as part of a changing paradigm in global healthcare delivery - all in the context of rapid innovations in technology and explosions of data sources, types, and volume. This book is therefore of considerable interest to all students of biomedical informatics, from the newcomer to the professional informatician.

This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book introduces and applies informatics concepts only as they have particular relevance to clinical research settings.

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