Practical Guide to Clinical Data Management, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1439848297
Total Pages : 298 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Practical Guide to Clinical Data Management, Third Edition by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management, Third Edition written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Guide to Clinical Data Management

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Author :
Publisher : CRC Press
ISBN 13 : 9781574910438
Total Pages : 298 pages
Book Rating : 4.9/5 (14 download)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 1999-01-31 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Practical Guide to Clinical Data Management, Second Edition

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Author :
Publisher : CRC Press
ISBN 13 : 9780849376153
Total Pages : 0 pages
Book Rating : 4.3/5 (761 download)

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Book Synopsis Practical Guide to Clinical Data Management, Second Edition by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management, Second Edition written by Susanne Prokscha and published by CRC Press. This book was released on 2006-08-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Data Management

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 9780387951591
Total Pages : 230 pages
Book Rating : 4.9/5 (515 download)

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Book Synopsis Medical Data Management by : Florian Leiner

Download or read book Medical Data Management written by Florian Leiner and published by Springer Science & Business Media. This book was released on 2003-01-14 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

Medical Data Management

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 0387217738
Total Pages : 204 pages
Book Rating : 4.3/5 (872 download)

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Book Synopsis Medical Data Management by : Florian Leiner

Download or read book Medical Data Management written by Florian Leiner and published by Springer Science & Business Media. This book was released on 2006-04-18 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

A Textbook of Clinical Ophthalmology

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Author :
Publisher : World Scientific
ISBN 13 : 9789812381507
Total Pages : 670 pages
Book Rating : 4.3/5 (815 download)

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Book Synopsis A Textbook of Clinical Ophthalmology by : R. Pitts Crick

Download or read book A Textbook of Clinical Ophthalmology written by R. Pitts Crick and published by World Scientific. This book was released on 2003 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: The material in this edition of A d104book of Clinical Ophthalmology has been thoroughly revised and expanded to include the latest research and practice. Containing 357 illustrations throughout the text, the book is not only a reasoned practical guide to the study of ophthalmology, but it embraces the ocular aspects of general diseases world-wide and basic methods of investigation and treatment where applicable.This book has references by page and illustration number, resulting from collaboration with the authors of Colour Atlas of Ophthalmology; the two books contain all together an outstanding 579 illustrations (343 in colour), including 16 stereo plates. Another companion book is The Ophthalmology Examinations Review, which aims at the most effective presentation of knowledge for examination purposes. Together these three compact and inexpensive books provide an excellent study basis for ophthalmologists in training, while supplementing their learning of clinical work and surgical technique with the essential study of recent research papers and review monographs.

Medical Informatics

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Publisher : Lulu.com
ISBN 13 : 9781435753563
Total Pages : 349 pages
Book Rating : 4.7/5 (535 download)

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Book Synopsis Medical Informatics by : Robert E. Hoyt

Download or read book Medical Informatics written by Robert E. Hoyt and published by Lulu.com. This book was released on 2008 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical informatics is a new field that combines information technology and clinical medicine to improve medical care, medical education and medical research. With over 1,000 references, this extensively updated second edition will serve as a practical guide for understanding the field of Medical Informatics. Topics covered include: Overview of Medical Informatics, Electronic Health Records, Interoperability, Patient Informatics, Online Medical Resources, Search Engines, Mobile Technology, Evidence Based Medicine, Clinical Practice Guidelines, Pay for Performance, Disease Management and Disease Registries, Patient Safety, Electronic Prescribing, Telemedicine, Picture Archiving and Communication Systems, Bioinformatics, Public Health Informatics, E-research, and Emerging Trends

A Practical Guide to Managing Clinical Trials

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Author :
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.

Medical Management: A Practical Guide

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Author :
Publisher : CRC Press
ISBN 13 : 144414541X
Total Pages : 336 pages
Book Rating : 4.4/5 (441 download)

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Book Synopsis Medical Management: A Practical Guide by : Hameen Markar

Download or read book Medical Management: A Practical Guide written by Hameen Markar and published by CRC Press. This book was released on 2012-08-31 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This essential guide provides a lifeline to authoritative, reliable information on medical management, giving you all the skills you need whether managing a junior colleague as a lead doctor, or running multidisciplinary consortia in the NHS or private sectors. Learn key skills from leadership, managing change, quality control, and project management through to doctors in difficulty, appraisals and revalidation, managing exceptional performance, and poor performance Comprehensive coverage of NHS and private healthcare, primary care, acute and emergency care, mental health, and many other sectors Gain insight into important topics such as healthcare innovations and technologies, implementing evidence-based medicine, medical education, patient safety, and primary care consortia Refine your management skills with advice, wisdom, and practical help from key opinion leaders, medical professionals, and management experts In this world of change, reforms and new government initiatives, can you afford not to build on your existing skills? Whether you are new to medical management or an experienced director wishing to stay up to date and refine your expertise, this book will be an invaluable source of advice to help you manage the delivery of high-quality care.

Acute Pain Management

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Publisher : CRC Press
ISBN 13 : 0429586310
Total Pages : 253 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Acute Pain Management by : Pamela E. Macintyre

Download or read book Acute Pain Management written by Pamela E. Macintyre and published by CRC Press. This book was released on 2014-12-04 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended, BMA Medical Book Awards 2015Comprehensive acute pain management no longer means only caring for patients with pain resulting from postoperative and trauma-related causes-it now includes managing patients with acute pain arising from a wide variety of conditions. Acute Pain Management: A Practical Guide provides health professional

Introduction to Health Research Methods

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Author :
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1284094383
Total Pages : 393 pages
Book Rating : 4.2/5 (84 download)

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Book Synopsis Introduction to Health Research Methods by : Kathryn H. Jacobsen

Download or read book Introduction to Health Research Methods written by Kathryn H. Jacobsen and published by Jones & Bartlett Publishers. This book was released on 2016-07-29 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: A step-by-step guide to conducting research in medicine, public health, and other health sciences, this clear, practical, and straightforward text demystifies the research process and empowers students (and other new investigators) to conduct their own original research projects.

Practical Guide to Clinical Data Management

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Author :
Publisher : CRC Press
ISBN 13 : 1040042112
Total Pages : 266 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2024-07-03 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

The CRC's Guide to Coordinating Clinical Research

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Author :
Publisher : CenterWatch
ISBN 13 :
Total Pages : 428 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The CRC's Guide to Coordinating Clinical Research by : Karen E. Woodin

Download or read book The CRC's Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.

Health Care Information Systems

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Publisher : John Wiley & Sons
ISBN 13 : 0470451734
Total Pages : 769 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Health Care Information Systems by : Karen A. Wager

Download or read book Health Care Information Systems written by Karen A. Wager and published by John Wiley & Sons. This book was released on 2009-06-24 with total page 769 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Selling Text in the Field Updated for the New Era of Health Care IT "This is the most comprehensive and authoritative book available for the field today." —Mark L. Diana, PhD, assistant professor and MHA program director, School of Public Health and Tropical Medicine, Tulane University "With health care information technology now in the national policy spotlight, this book should be required reading for every health care administrator and student." —Mark Leavitt, MD, PhD, chairman, Certification Commission for Healthcare Information Technology "The book provides an excellent overview of foundational principles and practical strategies—a valuable reference for health administration and health informatics students and professionals." —Eta S. Berner, EdD, professor, Department of Health Services Administration, University of Alabama, Birmingham "The authors skillfully provide the tools necessary to facilitate movement from a paper-based to an electronic health record environment while championing the importance of managing in such an environment." — Melanie S. Brodnik, PhD, director and associate professor, School of Allied Medical Professions, Ohio State University "Deploying health care information technology today is like navigating whitewater in the midst of a raging storm. Leveraging investments while introducing significant change is no easy task. It requires focused attention, a spirit of collaboration, and a willingness to learn from others. This book is written for the IT leader who is willing to tackle these challenges." —Stephanie Reel, CIO and vice provost for Information Technologies, Johns Hopkins University

A Clinical Trials Manual From The Duke Clinical Research Institute

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu

Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

Ethical and Regulatory Aspects of Clinical Research

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Publisher :
ISBN 13 :
Total Pages : 532 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Case Management in Healthcare

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Author :
Publisher : Saunders
ISBN 13 :
Total Pages : 424 pages
Book Rating : 4.4/5 (91 download)

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Book Synopsis Case Management in Healthcare by : Peggy Rossi

Download or read book Case Management in Healthcare written by Peggy Rossi and published by Saunders. This book was released on 1999 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Case Management in Health Care" is a comprehensive reference designed to educate nurses and other health care professionals on the processes involved in case management. This reference discusses interventions and collaboration efforts that are necessary to move the patient through the continuum of care. It explores the changes in case management and it explains the financial, legal, and service aspects of this field. It is appropriate for nursing students (undergraduate and graduate) as well as for practicing case managers. • Focuses on the most current topics that are based on the changes and trends in case management and health care. • Addresses health care policies, laws and regulations as they apply to a case manager's day-to-day responsibilities. • Presents the basics on health insurance and the alternate funding programs equipping case managers to become active advocates for their patients. • Explores the pitfalls and barriers frequently encountered when locating appropriate patient resources, and explains how to overcome them. • Discusses various levels of care and treatment settings outside the acute care setting (ex. skilled nursing facility and home health care). • Explains the increasing number of case management models that are being used in various clinical settings. • Compares the roles and responsibilities of a utilization manager and a case manager, emphasizing the need for their collective efforts in providing quality patient care. • Case Management and Technology, focuses on systems support, technology tools and resources, meaningful reporting, using the Internet, and video conferencing in relation to effectively serving patients. • Quality Management for Case Managers, covers guidelines for quality management, organization standards and practices, accountability, increasing customer satisfaction, and measuring utilization and costs. • Audits, identifies auditing entities and discusses development of successful competency programs to meet regulatory standards specific to case management. • The Importance of Credentialing, discusses the significance of credentialing as the start of the quality process of an organization. • Discusses new modalities for case management such as demand management, care management, drug state management, and disability management. • Addresses the complexity of the moral and ethical issues facing today's case managers. • Includes content on worker's compensation, on-site vs. telephonic case management, and tools to improve the case management practice. • Tips and training tools for care givers are updated to include agencies, literature, and various web sites dedicated to care giving. • Expanded content on legal and legislative issues such as the Balanced Budget Act (BBA), Emergency Medical Treatment and Active Labor Act (EMTALA), and Health Insurance Portability and Accountability Act (HIPPA). • Provides current coverage of funding and insurance programs such as Medicare, Medicaid, Children's health coverage, Veteran's benefits, and TRICARE. • Content in Complex Care and Post Acute Care units have been expanded to include the latest advances in emergency care, hospice, and managing geriatric, transplant, mentally ill patients. • Each chapter begins with Objectives that list key points and focus the reader on essential content to better prepare them for learning. • Suggested Websites and Resources listed at the end of chapter provide reader with opportunity for further study and research. • End of Chapter Exercises (1-5 questions) promote active learning and application of pertinent content.