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Tables of Contents for Eclinical Trials
Chapter/Section Title
Page #
Page Count
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