Guide For Clinical Trial Staff


Guide For Clinical Trial Staff
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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.



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



The Fundamentals Of Clinical Research


The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26

The Fundamentals Of Clinical Research written by P. Michael Dubinsky 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 2022-01-26 with Medical categories.


This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources



The Investigator S Guide To Clinical Research


The Investigator S Guide To Clinical Research
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Author : David Ginsberg
language : en
Publisher:
Release Date : 2002

The Investigator S Guide To Clinical Research written by David Ginsberg and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Medical categories.


The Investigator's Guide to Clinical Research is a step-by-step manual filled with tips, instructions and insights for investigators - novice and experienced - and health professionals involved in conducting clinical research. Along with updated sections, charts and statistics, the 3rd edition includes a detailed look at investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. A new appendix includes valuable lists of company contacts and additional resources. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include...An overview of the clinical development process; A review of regulatory requirements; How to set up and manage a research center; How to effectively and efficiently conduct clinical trials and How to identify and secure clinical grant opportunities.



Documentation Of Clinical Trial Monitoring


Documentation Of Clinical Trial Monitoring
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Author : Edyta Niebrzegowska
language : en
Publisher: Troubador Publishing Ltd
Release Date : 2019-02-28

Documentation Of Clinical Trial Monitoring written by Edyta Niebrzegowska and has been published by Troubador Publishing Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-28 with Medical categories.


This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.



A Guide To Clinical Drug Research


A Guide To Clinical Drug Research
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Author : A. Cohen
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-04-17

A Guide To Clinical Drug Research written by A. Cohen and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-04-17 with Medical categories.


A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.



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.



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.



Clinical Research Coordinator S Manual


Clinical Research Coordinator S Manual
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Author : Kane Williams
language : en
Publisher:
Release Date : 2017-05-15

Clinical Research Coordinator S Manual written by Kane Williams and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-15 with categories.


This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get:# Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial.# Discussion on day-to-day challenges and their solutions.# Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly.# Guidance through strategies and measures to execute critical clinical trial activities.# Training on regulatory and ICH-GCP guidelines.# Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB.# Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.



Responsible Research


Responsible Research
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Author : Philip A. Cola
language : en
Publisher: Remedica
Release Date : 2006

Responsible Research written by Philip A. Cola 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.


The editors (of U. Hospitals of Cleveland and Rx Trials, Inc.) offer a guide to the practical and ethical issues in the conduct of clinical research coordinators that places the topic in broad international perspective by including approaches from the European Union, Japan, Canada, and the United States. Thirteen chapters discuss ethics and human subjects protection, responsible conduct, the informed consent process, pediatric informed consent and assent, study implementation and start-up, recruitment and retention of research subjects, documentation, quality assurance in clinical trials, communication, education and training, and future trends in professionalization. Distributed in the US by BookMasters. Annotation :2006 Book News, Inc., Portland, OR (booknews.com).