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Author: Kate Davis
Publisher: CRC Press
ISBN: 9780971252905
Category : Medical
Languages : en
Pages : 305
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Book Description
Written by members of the Duke Clinical Research Institute (DCRI) who develop instructional materials for on-site clinical trialists, this exciting, well-produced, practical book bridges the gap between the theory of clinical trial design, along with the statistical and clinical interpretations of data, and the process of conducting clinical trials. The authors have pulled together information relating to the pragmatic conduct of clinical trials and organized all of it into a single, invaluable volume.
Author: Kate Davis
Publisher: CRC Press
ISBN: 9780971252905
Category : Medical
Languages : en
Pages : 305
Get Book Here
Book Description
Written by members of the Duke Clinical Research Institute (DCRI) who develop instructional materials for on-site clinical trialists, this exciting, well-produced, practical book bridges the gap between the theory of clinical trial design, along with the statistical and clinical interpretations of data, and the process of conducting clinical trials. The authors have pulled together information relating to the pragmatic conduct of clinical trials and organized all of it into a single, invaluable volume.
Author: Margaret Liu
Publisher: John Wiley & Sons
ISBN: 1444357883
Category : Medical
Languages : en
Pages : 381
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Book Description
"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Author: Margaret Liu
Publisher: Wiley-Blackwell
ISBN: 1444315226
Category : Medical
Languages : en
Pages : 424
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Book Description
"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848319
Category : Computers
Languages : en
Pages : 278
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Book Description
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then,
Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292
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Book Description
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.
Author: Janet Gough
Publisher: CRC Press
ISBN: 1420025821
Category : Medical
Languages : en
Pages : 495
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Book Description
A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective
Author: Melissa Graboyes
Publisher: Ohio University Press
ISBN: 0821445340
Category : Science
Languages : en
Pages : 267
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Book Description
The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society.
Author: Tena Bastian
Publisher: Turner Publishing Company
ISBN: 0470145838
Category : Pets
Languages : en
Pages : 226
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Book Description
Praise for The Horses We Love, The Lessons We Learn "Tena's real-life stories are modern-day parables for the lessons horses have to teach us: Learn from your mistakes, trust your instincts and, above all, have fun. Some stories made me laugh out loud as I recalled being in similar predicaments. Others touched an emotional chord and made me cry. I came away from them longing to be in the nurturing presence of horses, soaking up all they have to offer--and always becoming a better person for it." --Stacey Nedrow-Wigmore, Managing Editor, Practical Horseman "This book captures the reader's attention and prompts a smile as each chapter concludes. Horsemen and non-horsemen alike will find the pages easy to read, inspiring, and down-to-earth as we are reminded to treasure all of life's experiences and practical lessons." --Coagi Long, Program Director, Equine Affaire A tribute to horses and a treasure for horse-lovers This unique book shares life lessons lovingly learned in the company of horses--universal lessons about facing adversity, finding your niche in life, second chances, and more. Humorous and touching, uplifting and poignant, the twenty-two stories inspire and delight.
Author: Donna Janell Bowman
Publisher: Lee & Low Books
ISBN: 9781620141489
Category : Juvenile Nonfiction
Languages : en
Pages : 0
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Book Description
A biography of William "Doc" Key, a former slave and self-trained veterinarian who taught his horse, Jim, to read, write, and do math, and who helped teach the world to treat animals kindly
Author: Nancy Rawles
Publisher: Crown
ISBN: 0307421341
Category : Fiction
Languages : en
Pages : 194
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Book Description
A deeply moving recasting of one of the most controversial characters in American literature, Huckleberry Finn’s Jim Written in the great literary tradition of novels of American slavery, My Jim is told in the incantatory voice of Sadie Watson, an ex-slave who schools her granddaughter with lessons of love she learned in bondage. To help her granddaughter confront the decisions she needs to make, Sadie mines her memory for the tale of the unquenchable love of her life, Jim. Sadie’s Jim was an ambitious young slave and seer who, when faced with the prospect of being sold, escaped down the Mississippi with a white boy named Huck. Sadie is suddenly left alone. Worried about her children, convinced her husband is dead, reviled as a witch, and punished for Jim’s escape, Sadie’s will and her love for Jim, even in absentia, animate her life and see her through. Told with spare eloquence and mirroring the true stories of countless slave women, My Jim re-creates one of the most controversial characters in American literature. A nuanced critique of the great American novel, My Jim stands on its own as a haunting and inspiring story about freedom, longing, and the remarkable endurance of love.
