Introducing professionals to the role of data management in clinical trials, Practical Guide to Clinical Data Management highlights current thinking about data management, focusing on responsibilities that typical data managers have today.

Features:

• Detailed requirements of 21CFR11 for electronic records and signatures
• New chapters on security and training of data collection staff and controlling access and security
• Software applications for CDM
• Clinical data collected for both drug and medical device clinical trials
• Explains how to use computerized data collection software
• Overviews of various documents to use as templates

Contents

Elements of the Process

• Data Management Plan
• Study Setup
• Creating Reports & Transferring Data
• Entering Data
• Managing Lab
• Coding Reported Terms
• Collecting Adverse Event Data
• Closing Studies
• Identifying & Managing Discrepancies
• Tracking CRF Data

Clinical Data Management Systems

• Where Systems Come From
• System Validation
• Choosing Vendor Products
• Test Plans
• Implementing New Systems
• Migrating Legacy Data
• Change Control

Special Topics

• Creating Data Standards
• SOPs and Guidelines
• Working With CROs
• Autocoder Algorithms
• CRF Design Considerations
• Remote Data Entry

Index

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