Practical Guide to Clinical Data Management / Edition 5

Practical Guide to Clinical Data Management / Edition 5

by Susanne Prokscha
     
 

ISBN-10: 1574910434

ISBN-13: 9781574910438

Pub. Date: 01/31/1999

Publisher: Taylor & Francis

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…  See more details below

Overview

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.

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    Product Details

    ISBN-13:
    9781574910438
    Publisher:
    Taylor & Francis
    Publication date:
    01/31/1999
    Edition description:
    Older Edition
    Pages:
    296
    Product dimensions:
    6.14(w) x 9.40(h) x 0.89(d)

    Table of Contents

    include:
    ELEMENTS OF THE PROCESS Data Management Plan Study Setup Tracking CRF Data Entering Data Managing Lab Data Identifying and Managing Discrepancies Collecting Adverse Event Data Coding Reported Terms Creating Reports and Transferring Data Closing Studies Identifying & Managing Discrepancies

    CDM SYSTEMS Where Systems Come From Choosing Vendor Products Implementing New Systems Systems Validation Test Plans Migrating Legacy Data Change Control

    SPECIAL TOPICS Creating Data Standards SOPs and Guidelines Working With CROs CRF Design Considerations Remote Data Entry Autocoder Algorithms

    APPENDICES Appendix A: Data Management Plan Outline Appendix B: Database Design Document Outline Appendix C: Validation Plan Outline Appendix D: Test Plan Outline

    GLOSSARY SELECTED READING INDEX

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