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Author: VIRUTI SHIVAN
Publisher: Viruti Satyan Shivan
ISBN:
Category : Medical
Languages : en
Pages : 227
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Book Description
In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, "Clinical Data Manager: The Comprehensive Guide" dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research.
Author: VIRUTI SHIVAN
Publisher: Viruti Satyan Shivan
ISBN:
Category : Medical
Languages : en
Pages : 227
Get Book Here
Book Description
In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, "Clinical Data Manager: The Comprehensive Guide" dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research.
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,
Author: Viruti Shivan
Publisher: Viruti Shivan
ISBN:
Category : Computers
Languages : en
Pages : 0
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Book Description
Mastering Data Integrity and Efficiency in Healthcare Research In the fast-evolving world of healthcare research, the role of a Clinical Data Manager has never been more critical. This guidebook serves as the ultimate roadmap for professionals aiming to excel in this challenging and rewarding field. Without the distraction of images or illustrations, "Clinical Data Manager: The Comprehensive Guide" dives deep into the core of managing clinical data with precision and strategic insight. The book unfolds the intricacies of data integrity, patient privacy, regulatory compliance, and technological advancements, tailored for both novices and seasoned professionals. Its pages are filled with actionable strategies, expert tips, and real-world scenarios that bring to light the profound impact of effective data management on healthcare outcomes. Stepping beyond conventional resources, this guide emphasizes the transformative role of data management in facilitating groundbreaking research and improving patient care. Through a unique blend of theoretical foundations and practical applications, it arms you with the knowledge and skills to navigate the complexities of clinical trials and big data analytics. It also addresses the current absence of visuals by engaging the reader's imagination and encouraging a deeper understanding through thought-provoking questions and exercises. As a beacon for aspiring and established data managers alike, this book promises not just to educate but to inspire a new wave of innovation in the field of healthcare research.
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: Florian Leiner
Publisher: Springer Science & Business Media
ISBN: 9780387951591
Category : Computers
Languages : en
Pages : 230
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Book Description
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.
Author: MARK. ELSLEY
Publisher:
ISBN: 9781912055210
Category :
Languages : en
Pages : 46
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Book Description
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: Susanne Prokscha
Publisher: CRC Press
ISBN: 9781574910438
Category : Medical
Languages : en
Pages : 298
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Book Description
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.
Author: Susanne Prokscha
Publisher: CRC Press
ISBN: 1439848297
Category : Computers
Languages : en
Pages : 298
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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, 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.
Author: Karen E. Woodin
Publisher: CenterWatch
ISBN:
Category : Medical
Languages : en
Pages : 428
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Book Description
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.
