A Practical Guide To Managing Clinical Trials
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A Practical Guide To Managing Clinical Trials
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Author : JoAnn Pfeiffer
language : en
Publisher:
Release Date : 2017
A Practical Guide To Managing Clinical Trials written by JoAnn Pfeiffer and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Clinical trials categories.
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.
A Practical Guide To Managing Clinical Trials
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Author : JoAnn Pfeiffer
language : en
Publisher:
Release Date : 2017
A Practical Guide To Managing Clinical Trials written by JoAnn Pfeiffer and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Clinical trials categories.
A Practical Guide To Managing Clinical Trials
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Author : JoAnn Pfeiffer
language : en
Publisher: CRC Press
Release Date : 2017-05-18
A Practical Guide To Managing Clinical Trials written by JoAnn Pfeiffer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-18 with Mathematics categories.
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.
A Practical Guide To Quality Management In Clinical Trial Research
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Author : Graham Ogg
language : en
Publisher: CRC Press
Release Date : 2005-11-01
A Practical Guide To Quality Management In Clinical Trial Research written by Graham Ogg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-01 with Medical categories.
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
An Introduction To Clinical Trials
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Author : Jonathan A. Cook
language : en
Publisher: Oxford University Press
Release Date : 2023
An Introduction To Clinical Trials written by Jonathan A. Cook and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023 with Computers categories.
An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the "ultimate" clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life. Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials.
Drug Design And Development
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Author : Chris Rostron
language : en
Publisher: Academic
Release Date : 2020
Drug Design And Development written by Chris Rostron and has been published by Academic this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Medical categories.
Drug Design and Development outlines the processes involved in the design and development of new drugs and emphasises the significance of these processes to the practice of pharmacy. The book highlights why it is important that all practicing pharmacists, including those working in hospitals or high street stores, have a solid understanding of the process of the design and development of the drugs they interact with. It adopts an integrated approach, formulated to complement courses which are designed in line with the General Pharmaceutical Council's new curriculum requirements. Furthermore, this is the only integrated textbook to consider both drug design and development within one volume. Throughout the book, the journey of the drug, from discovery to market, is presented in an integrated fashion, emphasising the interconnection of all the processes involved.
Behavioral Clinical Trials For Chronic Diseases
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Author : Lynda H. Powell
language : en
Publisher: Springer Nature
Release Date : 2021-10-13
Behavioral Clinical Trials For Chronic Diseases written by Lynda H. Powell and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-13 with Psychology categories.
This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.
A Comprehensive And Practical Guide To Clinical Trials
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Author : Delva Shamley
language : en
Publisher: Academic Press
Release Date : 2017-06-07
A Comprehensive And Practical Guide To Clinical Trials written by Delva Shamley and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-07 with Medical categories.
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
Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-26 with Computers categories.
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,
Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2024-07-03
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-03 with Medical categories.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.