Clini-Data Manual
Title | Clini-Data Manual PDF eBook |
Author | A Arturo Rodriguez |
Publisher | |
Pages | |
Release | 2001-01-01 |
Genre | |
ISBN | 9789686277791 |
Practical Guide to Clinical Data Management
Title | Practical Guide to Clinical Data Management PDF eBook |
Author | Susanne Prokscha |
Publisher | CRC Press |
Pages | 298 |
Release | 1999-01-31 |
Genre | Medical |
ISBN | 9781574910438 |
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 Clinical Data Management Resource Manual
Title | The Clinical Data Management Resource Manual PDF eBook |
Author | |
Publisher | |
Pages | |
Release | 1995 |
Genre | Clinical trials |
ISBN |
Medical Data Management
Title | Medical Data Management PDF eBook |
Author | Florian Leiner |
Publisher | Springer Science & Business Media |
Pages | 208 |
Release | 2003 |
Genre | Business & Economics |
ISBN | 0387955941 |
1. What is Medical Data Management About?; 2. Basic Concepts of Clinical Data Management and Coding Systems; 3. Important Medical Coding Systems; 4. Typical Medical Documentation; 5. Utilization of Clinical Data Management Systems; 6. Clinical Data Management: Let's Make a Plan!; 7. Documentation in Hospital Information Systems; 8. Data Management in Clinical Studies; 9. Concluding Remarks; 10. Suggested Further Information; 11. Thesaurus of Medical Documentation.
Practical Guide to Clinical Data Management, Second Edition
Title | Practical Guide to Clinical Data Management, Second Edition PDF eBook |
Author | Susanne Prokscha |
Publisher | CRC Press |
Pages | 0 |
Release | 2006-08-01 |
Genre | Medical |
ISBN | 9780849376153 |
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 - A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures Practices for both electronic data capture (EDC)-based and paper-based studies 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.
Instruction Manual
Title | Instruction Manual PDF eBook |
Author | |
Publisher | |
Pages | 80 |
Release | 1990 |
Genre | Mortality |
ISBN |
Design of Research and Analysis of Data in the Clinic
Title | Design of Research and Analysis of Data in the Clinic PDF eBook |
Author | |
Publisher | |
Pages | 74 |
Release | 1982 |
Genre | |
ISBN |