Practical Guide To Clinical Data Management Third Edition
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Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2011-10-26
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 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,
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.
Medical Management A Practical Guide
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Author : Hameen Markar
language : en
Publisher: CRC Press
Release Date : 2012-08-31
Medical Management A Practical Guide written by Hameen Markar and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-08-31 with Business & Economics categories.
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 managemen
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.
Practical Guide To Clinical Data Management
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2024-07-03
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 2024-07-03 with Medical categories.
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.
Clinical Analytics And Data Management For The Dnp Second Edition
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Author : Martha L. Sylvia
language : en
Publisher: Springer Publishing Company
Release Date : 2018-03-28
Clinical Analytics And Data Management For The Dnp Second Edition written by Martha L. Sylvia and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
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
Multivariable Analysis
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Author : Mitchell H. Katz
language : en
Publisher: Cambridge University Press
Release Date : 2006-02-09
Multivariable Analysis written by Mitchell H. Katz and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-02-09 with Mathematics categories.
How to perform and interpret multivariable analysis, using plain language rather than complex derivations.
Clinical Supervision In The Helping Professions
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Author : Gerald Corey
language : en
Publisher: John Wiley & Sons
Release Date : 2014-12-01
Clinical Supervision In The Helping Professions written by Gerald Corey 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 2014-12-01 with Psychology categories.
This straightforward guide for new and practicing supervisors emphasizes the attainment of skills necessary to effectively supervise others in a variety of settings. Topics covered include the roles and responsibilities of supervisors, the supervisory relationship, models and methods of supervision, becoming a multiculturally competent supervisor, ethical and legal issues in supervision, managing crisis situations, and evaluation in supervision. User-friendly tips, case examples, sample forms, questions for reflection, and group activities are included throughout the text, as are contributing supervisors’ Voices From the Field and the Authors’ Personal Perspectives—making this an interactive learning tool that is sure to keep readers interested and involved. *Requests for digital versions from ACA can be found on www.wiley.com. *To purchase print copies, please visit the ACA website. *Reproduction requests for material from books published by ACA should be directed to [email protected]
Anorectal And Colonic Diseases
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Author : Jean-Claude Givel
language : en
Publisher: Springer Science & Business Media
Release Date : 2009-11-14
Anorectal And Colonic Diseases written by Jean-Claude Givel 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 2009-11-14 with Medical categories.
This fully revised new edition focuses on the clinical, diagnostic, and therapeutic aspects of conditions encountered by the coloproctologist and gastroenterological surgeon, who are faced with an increasing number of precise and specific treatment modalities.
Writing And Managing Sops For Gcp
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Author : Susanne Prokscha
language : en
Publisher: CRC Press
Release Date : 2015-07-29
Writing And Managing Sops For Gcp 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 2015-07-29 with Computers categories.
This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management.