Guide To Clinical Trials


Guide To Clinical Trials
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A Practical Guide To Managing Clinical Trials


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 Concise Guide To Clinical Trials


A Concise Guide To Clinical Trials
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Author : J. Rick Turner
language : en
Publisher:
Release Date : 2011-09-01

A Concise Guide To Clinical Trials written by J. Rick Turner and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-01 with Clinical trials categories.


Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.



The Comprehensive Guide To Clinical Research


The Comprehensive Guide To Clinical Research
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Author : Chris Sauber
language : en
Publisher: Independently Published
Release Date : 2019-04-21

The Comprehensive Guide To Clinical Research written by Chris Sauber and has been published by Independently Published this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-21 with categories.


Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps



Clinical Trials


Clinical Trials
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Author : Duolao Wang
language : en
Publisher: Remedica
Release Date : 2006

Clinical Trials written by Duolao Wang and has been published by Remedica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.


This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.



A Comprehensive And Practical Guide To Clinical Trials


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 Accompanied by a website with PowerPoint slides and an image bank



A Concise Guide To Clinical Trials


A Concise Guide To Clinical Trials
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Author : Allan Hackshaw
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-07

A Concise Guide To Clinical Trials written by Allan Hackshaw and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-07 with Medical categories.


Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies



Guide For Clinical Trial Staff


Guide For Clinical Trial Staff
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Author : Gerhard Fortwengel
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2004

Guide For Clinical Trial Staff written by Gerhard Fortwengel and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Medical categories.


The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.



All You Need To Know About Clinical Research


All You Need To Know About Clinical Research
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Author : Sanjay Gupta
language : en
Publisher: Dna Press
Release Date : 2010

All You Need To Know About Clinical Research written by Sanjay Gupta and has been published by Dna Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Health & Fitness categories.


This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.



Guide To Clinical Trials


Guide To Clinical Trials
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Author : Bert Spilker
language : en
Publisher:
Release Date : 1991

Guide To Clinical Trials written by Bert Spilker and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Clinical Trials categories.




Guide To Clinical Trials


Guide To Clinical Trials
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Author : Bert Spilker
language : en
Publisher:
Release Date : 1991

Guide To Clinical Trials written by Bert Spilker and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Clinical Trials categories.