Eclinical Trials,9781930624283

Eclinical Trials

by ; ;
ISBN13: 9781930624283
ISBN10: 193062428X
Format: Paperback
Pub. Date: 2003-09-01
Publisher(s): Centerwatch Inc
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Summary

Explores, in depth, the application of new technologies and redesigned processes to streamline clinical trials. Discusses information sharing among healthcare delivery systems about basic clinical research and clinical trials. Discusses the process, a vision of future clinical trials, redesigning and implementing new methods. Softcover.

Author Biography

Rebecca Daniels Kush, Ph.D., is a founder and the current president of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization dedicated to the development of global data interchange standards

Table of Contents

Chapter 1 Setting the Stage: An Overview 9(6)
Clinical Trials-A Place to Begin
12(3)
Chapter 2 Today's Clinical Trial 15(21)
Objectives
15(1)
Introduction
15(1)
The Clinical Research Cycle-Paper-Based
16(7)
The Clinical Research Cycle-The Technology That Can Be Applied Today
23(12)
Conclusion
35(1)
Chapter 3 The Optimal Electronic Clinical Trial-A Vision for the Future 36(18)
Objectives
36(1)
Introduction
36(1)
Goals for the Optimal Electronic Clinical Trial
37(14)
The Vision-Putting It All Together
51(2)
Conclusion
53(1)
Chapter 4 Process Redesign and Supporting Technologies 54(18)
Objectives
54(1)
Introduction
54(1)
Shredding the Paper-Process Redesign
55(6)
Metrics for Assessing Newly Introduced Technology
61(2)
Supporting Technologies and Services for eCTs
63(6)
Conclusion
69(3)
Chapter 5 Achieving eClinical Trials 72(8)
Objectives
72(1)
Introduction
72(1)
Elements for Implementing eClinical Trials
73(5)
Special Implementation Considerations for eCTs
78(1)
Conclusion
79(1)
Chapter 6 Measuring and Managing for Success: Metrics for Electronic Clinical Trials 80(11)
Objectives
80(1)
Introduction
80(1)
Clinical Trials Metrics Collection
81(8)
Conclusion
89(2)
Chapter 7 Performing Electronic Clinical Trials in Accord with Regulations 91(17)
Objectives
91(1)
Agency Aim in Creating 21 CFR 11
92(2)
Regulatory Considerations in Planning an Electronic Clinical Trial
94(6)
Regulatory Considerations While Executing an Electronic Clinical Trial
100(6)
Conclusion
106(2)
Chapter 8 Data Quality and Data Integrity 108(6)
Objectives
108(1)
Definitions of Data Quality and Data Integrity
109(1)
Error Sources
109(1)
Basic Principles
110(3)
Conclusion
113(1)
Chapter 9 The Impact of eClinical Trial Technology on Safety Surveillance and IRBs 114(10)
Objectives
114(1)
Time Delay
115(1)
Responsibilities for Monitoring Patient Safety
115(6)
Patient Privacy
121(2)
Conclusion
123(1)
Chapter 10 Industry Data Standards: Ensuring the Success of Electronic Clinical Trial Implementations 124(10)
Objectives
124(1)
The Value of Standards
125(5)
The CDISC Operational Data Model
130(2)
Further Progress on Clinical Data Standards
132(1)
Conclusion
132(2)
Appendix A Endnotes 134(3)
Appendix B Selected Reading 137(2)
Appendix C Glossary 139(17)
Appendix D Traceability Matrix 156(7)
Appendix E 21 CFR Part 11 163(8)
Appendix F Guidance for Industry: Computerized Systems Used in Clinical Trials [CSUCT] 171(13)
About CenterWatch 184(7)
About the Authors 191

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