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Clinical Studies Management

Author: Simon Cook
Publisher: CRC Press
ISBN: 0849320844
Size: 24.92 MB
Format: PDF, Kindle
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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.

A Comprehensive And Practical Guide To Clinical Trials

Author: Delva Shamley
Publisher: Academic Press
ISBN: 0128047305
Size: 43.68 MB
Format: PDF
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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

Case Management

Author: Suzanne K. Powell
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781718837
Size: 12.93 MB
Format: PDF, Docs
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The Second Edition of this comprehensive "how to" text has been completely revised and updated. This text outlines the basics of case management and illustrates some of the pitfalls encountered in the field of case management. The book provides information on the new Case Management Standards, supplies standard definitions and guidelines of case management for the practicing case manager, and presents information on caring for clients in a wide variety of health care settings. New to this edition--chapters focusing on Quality Reviews and Risk Management with a strong emphasis on Continuous Quality Improvement (CQI), ethical and legal issues, and various case studies.

Practical Guide To Clinical Data Management

Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 9781574910438
Size: 31.56 MB
Format: PDF, Kindle
View: 548
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Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. And clinical data manages have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers you through a basic understanding of the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. This book helps you ensure GCP, manage laboratory data, and deal with the kinds of clinical data that can cause difficulties in database applications. With the tools this book provides, you'll learn how to: Ensure that your DMB system is in compliance with federal regulations Build a strategic data management and databsing plan Track and record CRFs Deal with problem data, adverse event data, and legacy data Manage and store lab data Identify and manage discrepancies Ensure quality control over reports Choose a CDM system that is right for your company Create and implement a system validation plan and process Set up and enforce data collection standards Develop test plans and change control systems This book is your guide to finding the most successful and practical options for effective clinical data management.

A Practical Guide To Managing Clinical Trials

Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Size: 54.90 MB
Format: PDF, ePub, Mobi
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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.

Practical Guide To Clinical Data Management Second Edition

Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 9780849376153
Size: 23.87 MB
Format: PDF
View: 6172
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The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures Practices for both electronic data capture (EDC)-based and paper-based studies A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

Practical Approach To The Management And Treatment Of Venous Disorders

Author: Neil S. Sadick
Publisher: Springer Science & Business Media
ISBN: 1447128907
Size: 66.90 MB
Format: PDF, ePub
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This book shall assist the microscopist in a practical way, with the help of three mainstays, a. clinical information, b. the resources a standard histopathology laboratory may offer and c. the light microscope, to approach and solve the diagnostic problems he/she may face in the field of dermatopathology. In fact, this is the way in which the senior author of this book has been successfully working over thirty years in his capacity as director of a private dermatopathology laboratory.

Drug Products For Clinical Trials

Author: Donald Monkhouse
Publisher: Informa Health Care
ISBN: 9780824798529
Size: 44.63 MB
Format: PDF, ePub, Mobi
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This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

Clinical Pain Management

Author: Mary E. Lynch
Publisher: John Wiley & Sons
ISBN: 9781444329735
Size: 47.73 MB
Format: PDF, Mobi
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Clinical Pain Management takes a practical, interdisciplinary approach to the assessment and management of pain. Concise template chapters serve as a quick reference to physicians, anesthetists and neurologists, as well as other specialists, generalists, and trainees managing pain. Based on the International Association for the Study of Pain’s clinical curriculum on the topic, this reference provides to-the-point best-practice guidance in an easy-to-follow layout including tables, bullets, algorithms and guidelines.

Practical Guide To Clinical Data Management Third Edition

Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848297
Size: 32.68 MB
Format: PDF, ePub, Mobi
View: 3693
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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, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.