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Practical Guide to Clinical Data Management, Third Edition

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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.

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