Practical Guide to Clinical Data Management Third Edition

Name: Practical Guide to Clinical Data Management Third Edition
Availability: InStock
ISBN: 9781439848296

ISBN-10: 1439848297

ISBN-13: 9781439848296

Edition: 3rd 2011 (Revised)

Authors: Susanne Prokscha

List price: $106.00

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Book details

List price: $106.00
Edition: 3rd
Copyright year: 2011
Publisher: CRC Press
Publication date: 11/18/2011
Binding: Hardcover
Pages: 296
Size: 6.25" wide x 9.50" long x 0.75" tall
Weight: 1.430
Language: English

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



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