3rd Edition

Practical Guide to Clinical Data Management

By Susanne Prokscha Copyright 2012
    296 Pages 26 B/W Illustrations
    by CRC Press

    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.

    STUDY STARTUP
    The Data Management Plan
    CRF Design Considerations
    Database Design Considerations
    Defining Edit Checks
    Preparing to Receive Data
    STUDY CONDUCT
    Receiving Data on Paper
    Overseeing Data Collection
    Cleaning Data
    Lab Data and Non-CRF Data
    Collecting AE Data
    Creating Reports and Transferring Data
    STUDY CLOSEOUT
    Preparing to Lock
    Quality Control
    Locking and Unlocking Studies
    NECESSARY INFRASTRUCTURE
    Standard Operating Procedures
    Training
    Controlling Access and Security
    Working with CROs and Service Providers
    CDM SYSTEMS
    CDM Systems
    Choosing Vendor Products
    Implementing New Systems
    System Validation
    Test Procedures
    Change Control
    Coding Dictionaries

    Biography

    Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.