Clinical Research Informatics

Section 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.- 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.- Patient Registries.- Section 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.- Section 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.- Index.

Rachel Richesson, MS, PhD, MPH, FACMI, a noted informaticist, joined the Duke University School of Nuring in December 2011. Dr. Richesson earned her BS (Biology) at the University of Massachusetts in 1991, and holds graduate degrees in Community Health (MPH, 1995) and Health Informatics (MS, 2000 and PhD, 2003) from the University of Texas Health Sciences Center in Houston. Dr. Richesson spent 7 years as at the University of South Florida College of Medicine directing strategy for the identification and implementation of data standards for a variety of multi-national multi-site clinical research and epidemiological studies housed within the USF Department of Pediatrics, including the NIH Rare Diseases Clinical Research Network (RDCRN) and The Environmental Determinants of Diabetes in the Young (TEDDY) study.

Dr Andrews is the Director of the University of South Florida, School of Information, and an Associate Professor of Information Science. His research falls broadly within the interdisciplinary field of health informatics. He has specific interests in clinical research informatics, as well as health-related information behaviours, particularly in the context of cancer genetics. He works collaboratively with researchers from USF Health, within SI, and also across the US and internationally.