Principles and practice of clinical research / edited by John I. Gallin, Frederick P. Ognibene, Laura Lee Johnson

Includes bibliographical references and index

Part I -- Ethical, Regulatory and Legal Issues Part II -- Biostatistics and Epidemiology Part III -- Technology Transfer, Protocol Development, and Sources of Funding Support for Research Part IV -- Clinical Research Infrastructure

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and "omicïŽ platforms, this edition contains new chapters devoted to electronic health records and informational resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting human research