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A Practical Guide to Human Research and Clinical Trials

A Practical Guide to Human Research and Clinical Trials
Author: M. U. R. Naidu
Publisher: CRC Press
Total Pages: 350
Release: 2013-01-29
Genre: Medical
ISBN: 9781466591172
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Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
Author: Delva Shamley
Publisher: Academic Press
Total Pages: 210
Release: 2017-06-07
Genre: Medical
ISBN: 0128047305
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A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Ethical Issues in Clinical Research

Ethical Issues in Clinical Research
Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
Total Pages: 302
Release: 2012-03-28
Genre: Medical
ISBN: 1451152779
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This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Clinical Trials and Human Research

Clinical Trials and Human Research
Author: Fay A. Rozovsky
Publisher: Jossey-Bass
Total Pages: 0
Release: 2003-06-10
Genre: Medical
ISBN: 9780787965709
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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Conducting Clinical Research

Conducting Clinical Research
Author: Judy Stone
Publisher:
Total Pages: 452
Release: 2006
Genre: Medical
ISBN:
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This guide to conducting clinical research emphasizes elements that are important for patient safety and investigator survival. Stone provides an overview of how research is conducted for drug companies and how to become involved in it, as well as career opportunities in medical research. She explains how sites attract studies, preparation, audits and regulatory requirements, recruiting volunteers for a study and implementing the protocol, career development, and ethics, politics, and social issues, including aspects relating to race, gender, and religion. Worksheets, forms, and supplementary information are provided in the extensive appendices. The guide is mostly aimed at physicians, but can be of use to nurses, study coordinators, and investigators. Stone is an internist and infectious disease specialist who has extensive experience in conducting clinical trials. Annotation ©2007 Book News, Inc., Portland, OR (booknews.co.

The Sourcebook for Clinical Research

The Sourcebook for Clinical Research
Author: Natasha Martien
Publisher: Academic Press
Total Pages: 278
Release: 2018-08-01
Genre: Medical
ISBN: 0128162430
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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
Author: JoAnn Pfeiffer
Publisher: CRC Press
Total Pages: 292
Release: 2017-05-18
Genre: Mathematics
ISBN: 1315299771
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

The Practical Guide to Clinical Research and Publication

The Practical Guide to Clinical Research and Publication
Author: Uzung Yoon
Publisher: Academic Press
Total Pages: 224
Release: 2021-08-03
Genre: Medical
ISBN: 0128245182
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The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching. Contains numerous, clinically-oriented examples and drawings Provides an explanation of epidemiology and statistics to aid understanding of clinical research Written by a physician with extensive knowledge in research

When Experiments Travel

When Experiments Travel
Author: Adriana Petryna
Publisher: Princeton University Press
Total Pages: 271
Release: 2009-04-27
Genre: Social Science
ISBN: 1400830826
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The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.