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A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.
A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.
Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.
The authors examine each stage of a fraud and abuse investigation, beginning with an overview of federal and state enforcement agencies, and concluding with a discussion of the potential collateral consequences of an investigation. They have supplemented their analysis extensively with sample documents, including indictments, requests for records, subpoenas, internal response memoranda, and responses to auditors, prosecutors, and more. Taken together, the materials in this book provide a true Handbook for anyone who needs to quickly and thoroughly understand the complex nature of a government fraud and abuse investigation.-Preface.
An anecdotal guide for the perplexed new investigator as well as a refreshing resource for the old pro, covering everything from valuable personality traits for an investigator to social factors conducive to scientific work. Santiago Ramón y Cajal was a mythic figure in science. Hailed as the father of modern anatomy and neurobiology, he was largely responsible for the modern conception of the brain. His groundbreaking works were New Ideas on the Structure of the Nervous System and Histology of the Nervous System in Man and Vertebrates. In addition to leaving a legacy of unparalleled scientific research, Cajal sought to educate the novice scientist about how science was done and how he thought it should be done. This recently rediscovered classic, first published in 1897, is an anecdotal guide for the perplexed new investigator as well as a refreshing resource for the old pro. Cajal was a pragmatist, aware of the pitfalls of being too idealistic—and he had a sense of humor, particularly evident in his diagnoses of various stereotypes of eccentric scientists. The book covers everything from valuable personality traits for an investigator to social factors conducive to scientific work.
Designed to assist practicing attorneys in all phases of a medical malpractice case, this practical handbook contains crucial information and strategies for handling the investigation of the suit, the use of expert witnesses, settlement discussions and trial strategies. Unlike most other works in the area, The Medical Malpractice Handbook also provides much needed concrete data on the determination of economic and noneconomic losses. Richard J. Arnould, Professor of Economics and Policy, University of Illinois at Champaign-Urbana, contributes a chapter on how to calculate economic losses. Bruce Livingston and Stephen Morewitz's expertise in medical-legal consulting gives their study a unique multi-disciplinary approach to the problem. Illustrated with case law and citations from different states, this new handbook constitutes a complete guide to medical malpractice.
The Rape Investigation Handbook is the first practical and hands-on manual written by sex crime investigators and forensic scientists, providing students with first-hand insight into the work of these professionals. It is the only comprehensive reference available on the investigation of sexual assault and rape. It includes extensive accounts of perpetrators, victims, and other rape case evidence for identification of incidents of rape. The key feature of this text is a thorough overview of the investigative and forensic processes related to sex crime investigation. It takes the reader through investigative and forensic processes in a logical sequence, showing how investigations of rape and sexual assault can and should be conducted from start to finish. This book is designed to be accessible, in terms of language and approach, to the student in the classroom learning about the subject for the first time. It is an excellent training manual for sex crime investigators as well as an excellent textbook for any hands-on university course on the subject of sex crime investigation. This book would also serve as a useful supplement for any investigative course involving violent crime or death investigation. * The only comprehensive reference available on the investigation of sexual assault and rape, a crime 10 times more prevalent than murder* Authored by qualified investigators and forensic professionals with more than twenty years of collective experience working cases, preparing them for court, and offering testimony* Written in a clear, practical style, ideal for professionals in forensic nursing, law enforcement, the legal community, and the investigative community