A Quick Guide To Clinical Trials

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A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.3/5 (152 download)

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Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer

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.

Quick Guide to Good Clinical Practice

Author : Cemal Cingi
Publisher : Springer
ISBN 13 : 3319443445
Total Pages : 237 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Quick Guide to Good Clinical Practice by : Cemal Cingi

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.

A Quick Guide to Clinical Trials

Author : Madhu Davies
Publisher : Ingram
ISBN 13 : 9781934106082
Total Pages : 0 pages
Book Rating : 4.1/5 (6 download)

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Book Synopsis A Quick Guide to Clinical Trials by : Madhu Davies

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:

An Introduction to Clinical Research

Author : Piers Page
Publisher : OUP Oxford
ISBN 13 : 0191629596
Total Pages : 224 pages
Book Rating : 4.1/5 (916 download)

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Book Synopsis An Introduction to Clinical Research by : Piers Page

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.

All You Need to Know about Clinical Research

Author : Sanjay Gupta
Publisher : Dna Press
ISBN 13 : 8190827715
Total Pages : 1 pages
Book Rating : 4.1/5 (98 download)

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Book Synopsis All You Need to Know about Clinical Research by : Sanjay Gupta

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.

The Comprehensive Guide To Clinical Research

Author : Chris Sauber
Publisher : Independently Published
ISBN 13 : 9781090349521
Total Pages : 218 pages
Book Rating : 4.3/5 (495 download)

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Book Synopsis The Comprehensive Guide To Clinical Research by : Chris Sauber

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

A Comprehensive and Practical Guide to Clinical Trials

Author : Delva Shamley
Publisher : Academic Press
ISBN 13 : 0128047305
Total Pages : 210 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis A Comprehensive and Practical Guide to Clinical Trials by : Delva Shamley

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

A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer
Publisher :
ISBN 13 : 9781138196506
Total Pages : 0 pages
Book Rating : 4.1/5 (965 download)

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Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer

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.

The Investigator's Guide to Clinical Research

Author : David Ginsberg
Publisher :
ISBN 13 :
Total Pages : 324 pages
Book Rating : 4.3/5 (555 download)

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Book Synopsis The Investigator's Guide to Clinical Research by : David Ginsberg

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.

The Sourcebook for Clinical Research

Author : Natasha Martien
Publisher : Academic Press
ISBN 13 : 9780128162422
Total Pages : 0 pages
Book Rating : 4.1/5 (624 download)

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Book Synopsis The Sourcebook for Clinical Research by : Natasha Martien

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.

Clinical Trials with Missing Data

Author : Michael O'Kelly
Publisher : John Wiley & Sons
ISBN 13 : 1118762533
Total Pages : 472 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Clinical Trials with Missing Data by : Michael O'Kelly

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.

Clinical Studies Management

Author : Simon Cook
Publisher : CRC Press
ISBN 13 : 9780849320842
Total Pages : 128 pages
Book Rating : 4.3/5 (28 download)

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Book Synopsis Clinical Studies Management by : Simon Cook

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.

12 Essential Activities of Clinical Trial Project Management

Author : T. C. George, Dr.
Publisher : CreateSpace
ISBN 13 : 9781503074132
Total Pages : 102 pages
Book Rating : 4.0/5 (741 download)

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Book Synopsis 12 Essential Activities of Clinical Trial Project Management by : T. C. George, Dr.

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.

Investigator Initiated Trials Simplified

Author : T. C. George
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781540762894
Total Pages : 106 pages
Book Rating : 4.7/5 (628 download)

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Book Synopsis Investigator Initiated Trials Simplified by : T. C. George

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.

Dictionary for Clinical Trials

Author : Simon Day
Publisher : John Wiley & Sons
ISBN 13 : 047031916X
Total Pages : 262 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis Dictionary for Clinical Trials by : Simon Day

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.

Guide for Investigator Initiated Trials

Author : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805596847
Total Pages : 189 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Guide for Investigator Initiated Trials by : Gerhard Fortwengel

Download or read book Guide for Investigator Initiated Trials written by Gerhard Fortwengel and published by Karger Medical and Scientific Publishers. This book was released on 2011 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential manual for beginners and senior researchers alike For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the International Conference on Harmonization and Good Clinical Practice'. This makes the publication at hand an essential cookbook' for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.

Randomised Controlled Trials

Author : Alejandro R. Jadad
Publisher : Wiley-Blackwell
ISBN 13 : 9780727912084
Total Pages : 123 pages
Book Rating : 4.9/5 (12 download)

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Book Synopsis Randomised Controlled Trials by : Alejandro R. Jadad

Download or read book Randomised Controlled Trials written by Alejandro R. Jadad and published by Wiley-Blackwell. This book was released on 1998 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: The contributors to this study present a balanced view of the strengths and weaknesses of randomised controlled trials in the medical setting. They cover all the essential issues without using statistics.