writing clinical research protocols ethical considerations

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Writing Clinical Research Protocols

Author : Evan DeRenzo
ISBN : 0080454208
Genre : Medical
File Size : 45. 57 MB
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This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Principles And Practice Of Clinical Research

Author : John I. Gallin
ISBN : 9780128499047
Genre : Science
File Size : 67. 5 MB
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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 “omic platforms, this edition contains new chapters devoted to electronic health records and information 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 research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Ethical And Regulatory Aspects Of Clinical Research

Author : Ezekiel J. Emanuel
ISBN : UOM:39015058788673
Genre : Medical
File Size : 34. 17 MB
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"Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics." -- Bulletin of the World Health Organization "This book provides excellent matieral on a broad variety of ethical topics in clinical research." -- Quality Assurance Journal All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process.

9 Steps Guide On How To Write A Clinical Trial Protocol

Author : K. Ashish
ISBN : 8192853748
Genre :
File Size : 85. 54 MB
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This book "9 Steps Guide On How To Write A Clinical Trial Protocol" is specially designed for the Clinical Trial investigators, Physicians, Sponsors, healthcare students and other clinical research professionals, who are involved or keen to explore clinical research in future to develop skills to write protocol for clinical studies. The books covers the topics Essential Clinical Trial Documents, Protocol Structure, Type of Research Studies, Trial Design Consideration, Ethical Consideration, Elementary Statistics, Randomization and its type, Blinding, Sample Sizing etc.The book is designed and written in a manner so that a reader can understand overall protocol writing and the essential element involved in it. We hope that the book would guide the readers to understand the overall process of protocol writing and impart essential skills involved in it.

Reviewing Clinical Trials

Author : Chinese University of Hong Kong
ISBN : 9881904110
Genre : Clinical trials
File Size : 82. 27 MB
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The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

The Crc S Guide To Coordinating Clinical Research

Author : Karen E. Woodin
ISBN : UOM:39015060767186
Genre : Medical
File Size : 41. 60 MB
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This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.

Biodesign

Author : Stefanos Zenios
ISBN : 9780521517423
Genre : Medical
File Size : 28. 60 MB
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Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Rheumatology E Book

Author : Marc C. Hochberg
ISBN : 9780702073069
Genre : Medical
File Size : 43. 62 MB
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Thoroughly revised and updated, the 7th Edition of Rheumatology remains a leading text in this fast-changing field, keeping you abreast of recent advances in medications, therapies, clinical trials, and much more. Dr. Mark Hochberg and his team of expert authors and editors cover everything you need to know -- from basic scientific principles to practical clinical management strategies, all in a user-friendly, accessible manner.

Rheumatoid Arthritis E Book

Author : Marc C. Hochberg
ISBN : 9780323071024
Genre : Medical
File Size : 24. 35 MB
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First Prize, Orthopaedics and Rheumatology, BMA Awards 2009 This state-of-the-art reference provides current insights into the etiology, diagnosis and management of rheumatoid arthritis. Leading international authorities in RA examine all of the latest scientific and clinical developments in understanding and managing this challenging disease, including new concepts in pathogenesis, epidemiology, risk factors, imaging, clinical outcomes and treatment. It’s the guidance you need to offer optimal care to your patients with rheumatoid arthritis. Presents the work of leading international experts in rheumatoid arthritis for guidance you can trust. Provides the very latest understanding of the pathogenesis of rheumatoid arthritis, including molecular pathways/mechanisms, and genetic and environmental factors that instigate and drive the disease. Includes comprehensive coverage of clinical features of rheumatoid arthritis including articular, peri-articular and extra-articular manifestations, comorbidities, and outcome measures—disease activity, joint assessment, imaging, and more—for expert diagnosis and monitoring of disease progression. Examines evidence-based treatment options—including traditional and biologic DMARDs and combination therapies—as well as promising therapies on the horizon, placing up-to-date guidance on disease modifying or disease controlling agents at your fingertips.

Pediatric Endocrinology Two Volume Set Fifth Edition

Author : Fima Lifshitz
ISBN : 9781420042733
Genre : Medical
File Size : 57. 83 MB
Format : PDF, Kindle
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Celebrating more than twenty years as the single best source in the field, this Fifth Edition has now expanded into two cornerstone volumes with 53 fully inclusive chapters and 73 renowned contributors that comprehensively address every topic and trend relevant to the identification, diagnosis, and management of endocrine and endocrine-related disorders in children. Substantially revised, the Fifth Edition covers the most up-to-date appraisal of obesity in the pediatric population, as well as examines the latest breakthroughs in the care of diabetes, hypoglycemia, insulin resistance, and hypoglycemic syndromes. This Fifth Edition also devotes chapters to the diseases of the endocrine glands, including disorders of growth, the adrenal cortex and medulla, as well as sexual differentiation, thyroid, and parathyroid conditions and fluid balance diseases.

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