A Practical Guide to Quality Management in Clinical Trial Research PDF Download

Author: Graham Ogg
Publisher: CRC Press
ISBN: 104006163X
Category : Medical
Languages : en
Pages : 229

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Book Description
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

Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292

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Book Description
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.

Author: Chris Sauber
Publisher: Independently Published
ISBN: 9781090349521
Category :
Languages : en
Pages : 218

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Book Description
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

Author: Duolao Wang
Publisher: Remedica
ISBN: 1901346722
Category : Medical
Languages : en
Pages : 497

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Book Description
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.

Author: Delva Shamley
Publisher: Academic Press
ISBN: 0128047305
Category : Medical
Languages : en
Pages : 212

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Book Description
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

Author: Uzung Yoon
Publisher: Academic Press
ISBN: 0128245182
Category : Medical
Languages : en
Pages : 224

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Book Description
The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching. - Contains numerous, clinically-oriented examples and drawings - Provides an explanation of epidemiology and statistics to aid understanding of clinical research - Written by a physician with extensive knowledge in research

Author: Wendy Bohaychuk
Publisher: John Wiley & Sons
ISBN: 9780471988243
Category : Medical
Languages : en
Pages : 234

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Book Description
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

Author: Robert Foley
Publisher: John Wiley & Sons
ISBN: 1119645573
Category : Medical
Languages : en
Pages : 176

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Book Description
How to Succeed in Medical Research is a practical resource for medical students and junior doctors across all specialties. Designed for busy readers seeking to distinguish themselves in a highly competitive environment, this concise yet comprehensive guide provides step-by-step advice on selecting a project, finding a mentor, conducting a study, analysing results, publishing a paper, communicating findings, and much more. Presented in an accessible and conversational style, 14 succinct chapters walk readers through the essential stages of their research journey, from the initial steps to getting involved in research as a medical student, to effectively balancing clinical work, scientific research, and other academic pursuits early in your career as a healthcare professional. The book is packed with real-world case studies and expert tips to help readers apply the content directly in their own studies and careers. Straightforward and easy-to-use, this valuable guide: Covers a variety of clinical research and presentation skills using clear and engaging language Provides detailed guidance on writing a paper, conducting a clinical audit, creating a CV and portfolio, and other key proficiencies Develops writing skills for literature reviews, critical appraisals, and case reports Discusses how to further medical careers through research electives, PhD studies, teaching, and quality improvement projects Offers a range of helpful learning features including objectives, key points, case studies, review questions, and links to references and further readings Includes PowerPoint templates for oral presentations and posters via a companion website How to Succeed in Medical Research: A Practical Guide is an ideal resource for medical students, junior doctors and other early career medical professionals.

Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
ISBN: 1451152779
Category : Medical
Languages : en
Pages : 302

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Book Description
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848319
Category : Computers
Languages : en
Pages : 296

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Book Description
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,