Practical Guide to Clinical Data Management 3rd Edition – Ebook PDF Version

Practical Guide to Clinical Data Management 3rd Edition – Ebook PDF Version – Digital Instant Dowload.

Product details:

• ISBN-10 ‏ : ‎ 1439848297
• ISBN-13 ‏ : ‎ 978-1439848296
• Author: Susanne Prokscha

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.

Table contents:

Chapter 1|6 pages
The Data Management Plan
Abstract
Chapter 2|14 pages
CRF Design Considerations
Abstract
Chapter 3|14 pages
Database Design Considerations
Abstract
Chapter 4|6 pages
Edit Checks
Abstract
Chapter 5|12 pages
Preparing to Receive Data
Abstract
Chapter 6|10 pages
Receiving Data on Paper
Abstract
Chapter 7|8 pages
Overseeing Data Collection
Abstract
Chapter 8|14 pages
Cleaning Data
Abstract
Chapter 9|10 pages
Managing Lab Data
Abstract
Chapter 10|6 pages
Non-CRF Data
Abstract
Chapter 11|10 pages
Collecting Adverse Event Data
Abstract
Chapter 12|10 pages
Creating Reports and Transferring Data
Abstract
Chapter 13|10 pages
Study Database Lock
Abstract
Chapter 14|6 pages
After Database Lock
Abstract
Chapter 15|10 pages
Standard Operating Procedures (SOPs)
Abstract
Chapter 16|6 pages
Training
Abstract
Chapter 17|6 pages
Controlling Access and Security
Abstract
Chapter 18|10 pages
Working with CROs
Abstract
Chapter 19|4 pages
Clinical Data Management Systems
Abstract
Chapter 20|8 pages
EDC Systems
Abstract
Chapter 21|8 pages
Choosing Vendor Products
Abstract
Chapter 22|8 pages
Implementing New Systems
Abstract
Chapter 23|8 pages
System Validation
Abstract
Chapter 24|6 pages
Test Procedures
Abstract
Chapter 25|6 pages
Change Control
Abstract
Chapter 26|10 pages
Coding Dictionaries and Systems
Abstract
Chapter 27|6 pages
Migrating and Archiving Data