Beschreibung
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.
Inhaltsverzeichnis
The Context Of Clinical Research And Clinical Research Informatics 1: Introduction to Clinical Research Informatics 2: Clinical Research Designs 3: Clinical Research Environment, Settings and Activities 4: Regulatory and Ethical issues in Clinical Research 5: "Good Clinical Research Practice" (GCP) Foundations for Clinical Research Informatics 6: Informatics applied to clinical research contexts - Theoretical foundations and contributing disciplines 7: System Analysis and Design to Support Clinical Research 8: Information Storage & Retrieval 9: Interoperability and Data Exchange 10: Data Quality and Quality Control Issues 11: Evaluation Systems, Standards, and Interoperability 12: Clinical Research Information Systems 13: Standards: overview and models 14: Terminological standards 15: Case Report Forms and data collection forms 16: Other types of data collection 17: Implementation of Standards 18: Registries and the Role of the Public in Clinical Research Building on the Foundations: Applications and Activities 19: Standards by Domain (Tuberculosis Common Data Elements project) 20: Implementing Terminology in a Distributed Research Network (SNOMED CT Implementation in the Rare Diseases Clinical Research Network) 21: CDISC Pilots: Reporting Data to FDA - Using the CDSIC SDTM model and supporting terminology to report to FDA. Experiences from the pilot study. 22: Protocol Representation (CDISC)- Issues in the structured representation of research protocols. 23: Terminology servers and services. caDSR, EVS, and LexGrid. 24: The BRIDG model Trends and Challenges 25: Ontologies 26: Translational research 27: Research and action agenda
Autorenporträt
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.
