Practical Guide to Clinical Data Management: 3rd Edition (Hardback) book cover

Practical Guide to Clinical Data Management

3rd Edition

By Susanne Prokscha

CRC Press

296 pages | 26 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9781439848296
pub: 2011-10-26
SAVE ~$38.00
$190.00
$152.00
x
eBook (VitalSource) : 9780429105524
pub: 2011-10-26
from $114.00


FREE Standard Shipping!

Description

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.

Table of Contents

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

About the Author

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

Subject Categories

BISAC Subject Codes/Headings:
COM021000
COMPUTERS / Database Management / General
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General