Practical Guide To Clinical Data Management Second Edition
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Practical Guide To Clinical Data Management Third Edition
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
Practical Guide To Clinical Data Management Third Edition written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-26 with Computers categories.
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 : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2006-08-01
Practical Guide To Clinical Data Management written by Susanne Prokscha and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-08-01 with Medical categories.
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
Management Of Data In Clinical Trials
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Author : Eleanor McFadden
language : en
Publisher: John Wiley & Sons
Release Date : 2007-12-14
Management Of Data In Clinical Trials written by Eleanor McFadden and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-14 with Mathematics categories.
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.
Medical Data Management
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Author : Florian Leiner
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-04-18
Medical Data Management written by Florian Leiner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-04-18 with Medical categories.
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.
Clinical Data Management
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Author : Richard K. Rondel
language : en
Publisher: John Wiley & Sons
Release Date : 2000-02-03
Clinical Data Management written by Richard K. Rondel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-02-03 with Medical categories.
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.
Clinical Data Management System A Complete Guide 2020 Edition
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Author : Gerardus Blokdyk
language : en
Publisher: 5starcooks
Release Date : 2020-01-28
Clinical Data Management System A Complete Guide 2020 Edition written by Gerardus Blokdyk and has been published by 5starcooks this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-28 with categories.
How to cause the change? What are the key elements of your Clinical data management system performance improvement system, including your evaluation, organizational learning, and innovation processes? How will success or failure be measured? Does your organization need more Clinical data management system education? How are policy decisions made and where? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role... In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Clinical Data Management System investments work better. This Clinical Data Management System All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Clinical Data Management System Self-Assessment. Featuring 949 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Clinical Data Management System improvements can be made. In using the questions you will be better able to: - diagnose Clinical Data Management System projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Clinical Data Management System and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Clinical Data Management System Scorecard, you will develop a clear picture of which Clinical Data Management System areas need attention. Your purchase includes access details to the Clinical Data Management System self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Clinical Data Management System Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
Good Clinical Data Management Practice A Complete Guide 2020 Edition
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Author : Gerardus Blokdyk
language : en
Publisher:
Release Date :
Good Clinical Data Management Practice A Complete Guide 2020 Edition written by Gerardus Blokdyk and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Good Clinical Data Management Practice A Complete Guide 2019 Edition
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Author : Gerardus Blokdyk
language : en
Publisher: 5starcooks
Release Date : 2019-03-18
Good Clinical Data Management Practice A Complete Guide 2019 Edition written by Gerardus Blokdyk and has been published by 5starcooks this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-18 with categories.
How do you calculate baseline data for a clinical or financial measure if you are a satellite applicant or current health center program look alike? What are all of your Good clinical data management practice domains and what do they do? Will it be accepted by users? What does the data mean to your clinical practice? How good is good? This limited edition Good clinical data management practice self-assessment will make you the trusted Good clinical data management practice domain authority by revealing just what you need to know to be fluent and ready for any Good clinical data management practice challenge. How do I reduce the effort in the Good clinical data management practice work to be done to get problems solved? How can I ensure that plans of action include every Good clinical data management practice task and that every Good clinical data management practice outcome is in place? How will I save time investigating strategic and tactical options and ensuring Good clinical data management practice costs are low? How can I deliver tailored Good clinical data management practice advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Good clinical data management practice essentials are covered, from every angle: the Good clinical data management practice self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Good clinical data management practice outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Good clinical data management practice practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Good clinical data management practice are maximized with professional results. Your purchase includes access details to the Good clinical data management practice self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Good clinical data management practice Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
New Drug Development
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Author : J. Rick Turner
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-07-16
New Drug Development written by J. Rick Turner and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-16 with Medical categories.
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
Good Clinical Data Management Practice A Complete Guide 2020 Edition
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Author : Gerardus Blokdyk
language : en
Publisher: 5starcooks
Release Date : 2019-09-29
Good Clinical Data Management Practice A Complete Guide 2020 Edition written by Gerardus Blokdyk and has been published by 5starcooks this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-29 with categories.
How good is good? What are you trying to accomplish? Who should participate? Why was this site chosen for inspection ? What information do you have about each key activity before you start the inspection ? This best-selling Good Clinical Data Management Practice self-assessment will make you the credible Good Clinical Data Management Practice domain authority by revealing just what you need to know to be fluent and ready for any Good Clinical Data Management Practice challenge. How do I reduce the effort in the Good Clinical Data Management Practice work to be done to get problems solved? How can I ensure that plans of action include every Good Clinical Data Management Practice task and that every Good Clinical Data Management Practice outcome is in place? How will I save time investigating strategic and tactical options and ensuring Good Clinical Data Management Practice costs are low? How can I deliver tailored Good Clinical Data Management Practice advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Good Clinical Data Management Practice essentials are covered, from every angle: the Good Clinical Data Management Practice self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Good Clinical Data Management Practice outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Good Clinical Data Management Practice practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Good Clinical Data Management Practice are maximized with professional results. Your purchase includes access details to the Good Clinical Data Management Practice self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Good Clinical Data Management Practice Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.