Practical Guide to Clinical Data Management 3rd Edition by Susanne Prokscha – Ebook PDF Instant Download/Delivery: 1439848319, 9781439848319
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ISBN 10: 1439848319
ISBN 13: 9781439848319
Author: Susanne Prokscha
Clinical data management (CDM) has gone from predominantly relying on the collection of data on paper forms to using electronic data capture (EDC). Today, the assumption is that a trial will be conducted using EDC and that extenuating circumstances might lead to it being conducted using paper. This third edition emphasizes the EDC process. The chapters in the text are organized to represent the main elements of CDM: study startup, study conduct, and study closeout. In addition, a new chapter on the clinical trial process explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow.
Practical Guide to Clinical Data Management 3rd Table of contents:
Introduction
Chapter 1: The Data Management Plan
Chapter 2: CRF Design Considerations
Chapter 3: Database Design Considerations
Chapter 4: Edit Checks
Chapter 5: Preparing to Receive Data
Chapter 6: Receiving Data on Paper
Chapter 7: Overseeing Data Collection
Chapter 8: Cleaning Data
Chapter 9: Managing Lab Data
Chapter 10: Non-CRF Data
Chapter 11: Collecting Adverse Event Data
Chapter 12: Creating Reports and Transferring Data
Chapter 13: Study Database Lock
Chapter 14: After Database Lock
Chapter 15: Standard Operating Procedures (SOPs)
Chapter 16: Training
Chapter 17: Controlling Access and Security
Chapter 18: Working with CROs
Chapter 19: Clinical Data Management Systems
Chapter 20: EDC Systems
Chapter 21: Choosing Vendor Products
Chapter 22: Implementing New Systems
Chapter 23: System Validation
Chapter 24: Test Procedures
Chapter 25: Change Control
Chapter 26: Coding Dictionaries and Systems
Chapter 27: Migrating and Archiving Data
Appendix A: Data Management Plan Outline
Appendix B: Clinical Data Management SOPs
Appendix C: CRO-Sponsor Responsibility Matrix
Appendix D: Implementation Plan Outline
Appendix E: Validation Plan Outline
Appendix F: CDISC and HIPAA
Bibliography
Back Cover
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Tags: Susanne Prokscha, Practical Guide, Clinical Data