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The Fundamentals of Clinical Data Management

2015-08-08 Clinical trials
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Release : 2015-08-08
Genre : Clinical trials
Kind : eBook
Book Rating : 576/5 ( reviews)

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Book Synopsis The Fundamentals of Clinical Data Management by : S. Fernandez

Download or read book The Fundamentals of Clinical Data Management written by S. Fernandez. This book was released on 2015-08-08. 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.

Fundamentals of Clinical Data Science

2018-12-21 Medical
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Release : 2018-12-21
Genre : Medical
Kind : eBook
Book Rating : 130/5 ( reviews)

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Book Synopsis Fundamentals of Clinical Data Science by : Pieter Kubben

Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben. This book was released on 2018-12-21. 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.

Practical Guide to Clinical Data Management

1999-01-31 Medical
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Release : 1999-01-31
Genre : Medical
Kind : eBook
Book Rating : 438/5 ( reviews)

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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. This book was released on 1999-01-31. 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.

The Fundamentals of Clinical Research

2022-01-26 Medical
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Release : 2022-01-26
Genre : Medical
Kind : eBook
Book Rating : 595/5 ( reviews)

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Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky. This book was released on 2022-01-26. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Clinical Data Management

2000-02-03 Medical
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Release : 2000-02-03
Genre : Medical
Kind : eBook
Book Rating : 293/5 ( reviews)

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Book Synopsis Clinical Data Management by : Richard K. Rondel

Download or read book Clinical Data Management written by Richard K. Rondel. This book was released on 2000-02-03. 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.

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