Practical Guide to Clinical Data Management, Second Edition

✍ Scribed by Susanne Prokscha

• Publisher: CRC Press
• Year: 2006
• Tongue: English
• Leaves: 254
• Edition: 2
• Category: Library

✦ Synopsis

The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include -A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signaturesPractices for both electronic data capture (EDC)-based and paper-based studiesA new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulationsThe edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task.Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality.

✦ Table of Contents

Front cover......Page 1
Preface......Page 6
The Author......Page 8
Contents......Page 10
part one. Elements of the process......Page 16
chapter one. The data management plan......Page 18
chapter two. CRF design considerations......Page 24
chapter three. Database design considerations......Page 34
chapter four. Study setup......Page 50
chapter five. Entering data......Page 58
chapter six. Tracking CRF pages and corrections......Page 68
chapter seven. Cleaning data......Page 76
chapter eight. Managing laboratory data......Page 90
chapter nine. Collecting adverse event data......Page 104
chapter ten. Creating reports and transferring data......Page 114
chapter eleven. Locking studies......Page 122
part two. Necessary infrastructure......Page 130
chapter twelve. Standard operating procedures and guidelines......Page 132
chapter thirteen. Training......Page 142
chapter fourteen. Controlling access and security......Page 148
chapter fifteen. Working with CROs......Page 154
part three. CDM systems......Page 162
chapter sixteen. Clinical data management systems......Page 164
chapter seventeen. Electronic data capture systems......Page 168
chapter eighteen. Choosing vendor products......Page 178
chapter nineteen. Implementing new systems......Page 186
chapter twenty. System validation......Page 194
chapter twenty one. Test procedures......Page 202
chapter twenty two. Change control......Page 208
chapter twenty three. Coding dictionaries......Page 214
chapter twenty four. Migrating and archiving data......Page 224
appendix A: Data management plan outline......Page 230
appendix B: Typical data management standard operating procedures......Page 234
appendix C: CRO-sponsor responsibility matrix......Page 236
appendix D. Implementation plan outline......Page 238
appendix E: Validation plan outline......Page 240
appendix F: CDISC and HIPAA......Page 242
Index......Page 244
Back cover......Page 254