Download or read book The Clinical Data Management Resource Manual written by and published by . This book was released on 1995 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 296 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,

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2006-08-01 with total page 254 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 t

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.

Download or read book Clinical Data Management written by Richard K. Rondel and published by John Wiley & Sons. This book was released on 2000-02-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

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 208 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.

Download or read book The Fundamentals of Clinical Data Management written by S. Fernandez and published by Createspace Independent Publishing Platform. This book was released on 2015-08-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Fundamentals of Clinical Data Management" is a manual for Sponsors, CROs, Investigators, Clinical Trial Monitors and Managers and Clinical Research Professionals to learn the basic concepts of Clinical Data Management. This book will focus on the topic which includes: Clinical Information Flow, Roles and Responsibilities of CDM Personnel, Guidelines Associated with CDM, Data Management Plan, CRF Designing, Data Collection, Cleaning and Data Validation, Study setup and Database Designing, Laboratory Data and Adverse Event Data Management, Report Creation and Data Closure, Data Archiving, Privacy and Security etc.

Download or read book Management of Data in Clinical Trials written by Eleanor McFadden and published by John Wiley & Sons. This book was released on 2007-12-14 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

Download or read book Clinical Analytics and Data Management for the DNP written by Martha L. Sylvia, PhD, MBA, RN and published by Springer Publishing Company. This book was released on 2018-03-28 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition: “DNP students may struggle with data management, since their projects are not research, but quality improvement, and this book covers the subject well. I recommend it for DNP students for use during their capstone projects." Score: 98, 5 Stars --Doody's Medical Reviews This is the only text to deliver the strong data management knowledge and skills that are required competencies for all DNP students. It enables readers to design data tracking and clinical analytics in order to rigorously evaluate clinical innovations/programs for improving clinical outcomes, and to document and analyze change. The second edition is greatly expanded and updated to address major changes in our health care environment. Incorporating faculty and student input, it now includes modalities such as SPSS, Excel, and Tableau to address diverse data management tasks. Eleven new chapters cover the use of big data analytics, ongoing progress towards value-based payment, the ACA and its future, shifting of risk and accountability to hospitals and clinicians, advancement of nursing quality indicators, and new requirements for Magnet certification. The text takes the DNP student step by step through the complete process of data management from planning to presentation, and encompasses the scope of skills required for students to apply relevant analytics to systematically and confidently tackle the clinical interventions data obtained as part of the DNP student project. Of particular value is a progressive case study illustrating multiple techniques and methods throughout the chapters. Sample data sets and exercises, along with objectives, references, and examples in each chapter, reinforce information. Key Features: Provides extensive content for rigorously evaluating DNP innovations/projects Takes DNP students through the complete process of data management from planning through presentation Includes a progressive case study illustrating multiple techniques and methods Offers very specific examples of application and utility of techniques Delivers sample data sets, exercises, PowerPoint slides and more, compiled in Supplemental Materials and an Instructor Manual

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.

Download or read book Clinical Analytics and Data Management for the DNP written by Martha L. Sylvia, PhD, MBA, RN and published by Springer Publishing Company. This book was released on 2023-01-18 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition: "DNP students may struggle with data management, since their projects are not research but quality improvement, and this book covers the subject well. I recommend it for DNP students for use during their capstone projects." Score: 98, 5 Stars -- Doody's Medical Reviews This unique text and reference—the only book to address the full spectrum of clinical data management for the DNP student—instills a fundamental understanding of how clinical data is gathered, used, and analyzed, and how to incorporate this data into a quality DNP project. The new third edition is updated to reflect changes in national health policy such as quality measurements, bundled payments for specialty care, and Advances to the Affordable Care Act (ACA) and evolving programs through the Centers for Medicare and Medicaid Services (CMS). The third edition reflects the revision of 2021 AACN Essentials and provides data sets and other examples in Excel and SPSS format, along with several new chapters. This resource takes the DNP student step-by-step through the complete process of data management, from planning through presentation, clinical applications of data management that are discipline-specific, and customization of statistical techniques to address clinical data management goals. Chapters are brimming with descriptions, resources, and exemplars that are helpful to both faculty and students. Topics spotlight requisite competencies for DNP clinicians and leaders such as phases of clinical data management, statistics and analytics, assessment of clinical and economic outcomes, value-based care, quality improvement, benchmarking, and data visualization. A progressive case study highlights multiple techniques and methods throughout the text. New to the Third Edition: New Chapter: Using EMR Data for the DNP Project New chapter solidifies link between EBP and Analytics for the DNP project New chapter highlights use of workflow mapping to transition between current and future state, while simultaneously visualizing process measures needed to ensure success of the DNP project Includes more examples to provide practical application exercises for students Key Features: Disseminates robust strategies for using available data from everyday practice to support trustworthy evaluation of outcomes Uses multiple tools to meet data management objectives [SPSS, Excel®, Tableau] Presents case studies to illustrate multiple techniques and methods throughout chapters Includes specific examples of the application and utility of these techniques using software that is familiar to graduate nursing students Offers real world examples of completed DNP projects Provides Instructor’s Manual, PowerPoint slides, data sets in SPSS and Excel, and forms for completion of data management and evaluation plan

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.

Download or read book Data Management written by Margaret E. Henderson and published by Rowman & Littlefield. This book was released on 2016-10-25 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: Libraries organize information and data is information, so it is natural that librarians should help people who need to find, organize, use, or store data. Organizations need evidence for decision making; data provides that evidence. Inventors and creators build upon data collected by others. All around us, people need data. Librarians can help increase the relevance of their library to the research and education mission of their institution by learning more about data and how to manage it. Data Management will guide readers through: Understanding data management basics and best practices. Using the reference interview to help with data management Writing data management plans for grants. Starting and growing a data management service. Finding collaborators inside and outside the library. Collecting and using data in different disciplines.

Download or read book Clinical Data Manager The Comprehensive Guide written by VIRUTI SHIVAN and published by Viruti Satyan Shivan. This book was released on with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Clinical Data Manager The Comprehensive Guide written by Viruti Shivan and published by Viruti Shivan. This book was released on 2024-03-22 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Download or read book Data Management for Researchers written by Kristin Briney and published by Pelagic Publishing Ltd. This book was released on 2015-09-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to everything scientists need to know about data management, this book is essential for researchers who need to learn how to organize, document and take care of their own data. Researchers in all disciplines are faced with the challenge of managing the growing amounts of digital data that are the foundation of their research. Kristin Briney offers practical advice and clearly explains policies and principles, in an accessible and in-depth text that will allow researchers to understand and achieve the goal of better research data management. Data Management for Researchers includes sections on: * The data problem – an introduction to the growing importance and challenges of using digital data in research. Covers both the inherent problems with managing digital information, as well as how the research landscape is changing to give more value to research datasets and code. * The data lifecycle – a framework for data’s place within the research process and how data’s role is changing. Greater emphasis on data sharing and data reuse will not only change the way we conduct research but also how we manage research data. * Planning for data management – covers the many aspects of data management and how to put them together in a data management plan. This section also includes sample data management plans. * Documenting your data – an often overlooked part of the data management process, but one that is critical to good management; data without documentation are frequently unusable. * Organizing your data – explains how to keep your data in order using organizational systems and file naming conventions. This section also covers using a database to organize and analyze content. * Improving data analysis – covers managing information through the analysis process. This section starts by comparing the management of raw and analyzed data and then describes ways to make analysis easier, such as spreadsheet best practices. It also examines practices for research code, including version control systems. * Managing secure and private data – many researchers are dealing with data that require extra security. This section outlines what data falls into this category and some of the policies that apply, before addressing the best practices for keeping data secure. * Short-term storage – deals with the practical matters of storage and backup and covers the many options available. This section also goes through the best practices to insure that data are not lost. * Preserving and archiving your data – digital data can have a long life if properly cared for. This section covers managing data in the long term including choosing good file formats and media, as well as determining who will manage the data after the end of the project. * Sharing/publishing your data – addresses how to make data sharing across research groups easier, as well as how and why to publicly share data. This section covers intellectual property and licenses for datasets, before ending with the altmetrics that measure the impact of publicly shared data. * Reusing data – as more data are shared, it becomes possible to use outside data in your research. This chapter discusses strategies for finding datasets and lays out how to cite data once you have found it. This book is designed for active scientific researchers but it is useful for anyone who wants to get more from their data: academics, educators, professionals or anyone who teaches data management, sharing and preservation. "An excellent practical treatise on the art and practice of data management, this book is essential to any researcher, regardless of subject or discipline." —Robert Buntrock, Chemical Information Bulletin