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 to the highly computerized specialty it is today. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include - 
<li>A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures 
</li>
<li>Practices for both electronic data capture (EDC)-based and paper-based studies 
</li>
<li>A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.</li>

Practical Guide to Clinical Data Management, Second Edition

Medical Books

Prokscha, Susanne

Pharmacology

CRC-Press

Practical Guide to Clinical Data Management

Computers & Technology

Computer Science

Science & Math

Chemistry

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: <ul>
<li>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</li> <li>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</li> <li>Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns</li>
</ul>
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.

Writing and Managing SOPs for GCP isthe first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (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. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

Writing and Managing SOPs for GCP

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: 
<li>Ensure that your DMB system is in compliance with federal regulations 
</li>
<li>Build a strategic data management and databsing plan 
</li>
<li>Track and record CRFs 
</li>
<li>Deal with problem data, adverse event data, and legacy data 
</li>
<li>Manage and store lab data 
</li>
<li>Identify and manage discrepancies 
</li>
<li>Ensure quality control over reports 
</li>
<li>Choose a CDM system that is right for your company 
</li>
<li>Create and implement a system validation plan and process 
</li>
<li>Set up and enforce data collection standards 
</li>
<li>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.</li>

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 regulationsBuild a strategic data management and databsing planTrack and record CRFsDeal with problem data, adverse event data, and legacy dataManage and store lab dataIdentify and manage discrepanciesEnsure quality control over reportsChoose a CDM system that is right for your companyCreate and implement a system validation plan and processSet up and enforce data collection standardsDevelop test plans and change control systemsThis book is your guide to finding the most successful and practical options for effective clinical data management.

Practical Guide To Clinical Data Management

Interpharm Press

See the best price to sell, buy, or rent books by Prokscha, Susanne. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Prokscha, Susanne

See the best price to sell, buy, or rent books by Prokscha, Susanne. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Practical Guide to Clinical Data Management, Second Edition

Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management

Writing and Managing SOPs for GCP

Practical Guide to Clinical Data Management

Practical Guide To Clinical Data Management