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.

Dr. Richesson is a Professor of Informatics at the University of Michigan School of Medicine, Department of Learning Health Sciences. She works with a number of different clinical research networks and pragmatic clinical trials, and supports the development and use of data standards. Dr. Andrews is an Associate Professor of Informatics in the School of Information at the University of South Florida. His scholarship focuses on a issues related to health information behaviors, particularly in the context of genetics, and terminologies in healthcare and research. Ms. Fultz Hollis is an informatician at Oregon Health & Science University in Portland, Oregon USA. She is particularly interested in all aspects of sharing research data accurately and with care for the quality and respect for data use and ownership. She has been extremely active for the past 8 years in editing and evaluating biomedical informatics research for the International Medical Informatics Association (IMIA Yearbook) and for the AMIA Summit and AMIA Annual conferences.