Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Quick Guide to Good Clinical Practice written by Cemal Cingi and published by Springer. This book was released on 2016-11-15 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Download or read book A Quick Guide to Clinical Trials written by Madhu Davies and published by Ingram. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book An Introduction to Clinical Research written by Piers Page and published by OUP Oxford. This book was released on 2011-11-10 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical book is written specifically for junior doctors by a team of highly experienced authors, as an introductory guide to clinical research. It covers all areas that a junior doctor needs to consider, including funding, study design, ethics, data analysis, disseminating findings, and furthering one's research career. It presents a balance view of clinical research and is written by authors actively involved in clinical research both at the 'coal-face' and at a more supervisory level. Research can be a difficult process and it is essential to make sure that the project is set up in the correct way in order to get verifiable results. This easy-to-read guide is available to help junior doctors develop a good study design and present evidence of a sound academic practice, which will make obtaining funding more likely and be time-efficient. Getting started early in research and developing a solid, gradual understanding of clinical research through using this approachable book will be of huge benefit to junior doctors and their discipline.

Download or read book The Comprehensive Guide To Clinical Research written by Chris Sauber and published by Independently Published. This book was released on 2019-04-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book All You Need to Know about Clinical Research written by Sanjay Gupta and published by Dna Press. This book was released on 2010 with total page 1 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Guide to Clinical Trials written by Bert Spilker and published by . This book was released on 1991 with total page 1156 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Concise Guide to Clinical Trials written by J. Rick Turner and published by . This book was released on 2011-09-01 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book A Comprehensive and Practical Guide to Clinical Trials written by Delva Shamley and published by Academic Press. This book was released on 2017-06-07 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Investigator s Guide to Clinical Research written by David Ginsberg and published by . This book was released on 2002 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Clinical Trials with Missing Data written by Michael O'Kelly and published by John Wiley & Sons. This book was released on 2014-02-14 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and credibility of a clinical trial, show by examples how a clinical team can work to prevent missing data, and present the reader with approaches to address missing data effectively. The book is illustrated throughout with realistic case studies and worked examples, and presents clear and concise guidelines to enable good planning for missing data. The authors show how to handle missing data in a way that is transparent and easy to understand for clinicians, regulators and patients. New developments are presented to improve the choice and implementation of primary and sensitivity analyses for missing data. Many SAS code examples are included – the reader is given a toolbox for implementing analyses under a variety of assumptions.

Download or read book Clinical Studies Management written by Simon Cook and published by CRC Press. This book was released on 2004-01-15 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies. The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change. If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.

Download or read book 12 Essential Activities of Clinical Trial Project Management written by T. C. George, Dr. and published by CreateSpace. This book was released on 2014-11-01 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book includes 12 essential activities undertaken by a project manager which includes Project Milestones Planning and Forecasting, Cost Estimate and Financial Planning, Logistics Planning, Vendor Selection and Management, Creation of Trial Master file, Management of Regulatory Document Submission, Co-ordination of Individual Site Set-up Activities, Import Export Requirements for Clinical Trials, Organization of Investigator Training Meeting, Study Initiation, Conduct and Milestones Tracking, Audit(s) and Quality Assurance, Regulatory Inspection, Study Closeout: Trial Completion, Suspension, Termination.

Download or read book Investigator Initiated Trials Simplified written by T. C. George and published by Createspace Independent Publishing Platform. This book was released on 2016-12-01 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to serve as a guide for the clinical trial investigator who is willing to initiate clinical study from their own. The chapters include Basics of IITs, IIT and Regulation, IIT and Association with Industry, Protocol Designing, Budget Preparation, Case Report Form, Informed Consent, Reporting, Clinical Trial Registration, EC Submission, Conduct and Monitoring, Data Management, CSR Preparation etc. Each chapter is thoughtfully developed to simplify the job of a clinical trial investigator.

Download or read book Dictionary for Clinical Trials written by Simon Day and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials. This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials. Wide ranging, brief, pragmatic explanations of clinical trial terminology Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology Thoroughly revised and expanded - increase of 280 terms from First Edition, reference to Cochrane included From the reviews of the First Edition: "This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts... Fully comprehensive - provides definitions of clinical trial terms in one complete volume... Includes extensive use of graphs throughout." LA DOC STI "...covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms... a useful adjunct to standard clinical trial texts... a reference source to keep within easy reach." TALANTA The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with clinical trials.