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eClinical trials : planning & implementation / Rebecca Daniels Kush and Paul Bleicher ... [and others].
Holman Biotech Commons R853.C55 K87 2003
Available
Levy Dental Medicine Library - Stacks R853.C55 K87 2003
Available
- Format:
- Book
- Author/Creator:
- Kush, Rebecca Daniels.
- Language:
- English
- Subjects (All):
- Clinical trials.
- Drugs--Testing.
- Drugs.
- Pharmaceutical industry--Technological innovations.
- Pharmaceutical industry.
- Clinical trials--Data processing.
- Clinical Trials as Topic--methods.
- Computers.
- Information Systems--organization & administration.
- Medical Subjects:
- Clinical Trials as Topic--methods.
- Computers.
- Information Systems--organization & administration.
- Physical Description:
- 194 pages : illustrations ; 23 cm
- Place of Publication:
- Boston, Mass. : Thomson/Centerwatch, [2003]
- Contents:
- Chapter 2 Today's Clinical Trial 15
- The Clinical Research Cycle
- Paper-Based 16
- The Technology 23
- That Can Be Applied Today
- Chapter 3 The Optimal Electronic Clinical Trial
- A Vision for the Future 36
- Goals for the Optimal Electronic Clinical Trial 37
- The Vision
- Putting It All Together 51
- Chapter 4 Process Redesign and Supporting Technologies 54
- Shredding the Paper
- Process Redesign 55
- Metrics for Assessing Newly Introduced Technology 61
- Supporting Technologies and Services for eCTs 63
- Chapter 5 Achieving eClinical Trials 72
- Elements for Implementing eClinical Trials 73
- Special Implementation Considerations for eCTs 78
- Chapter 6 Measuring and Managing for Success: Metrics for Electronic Clinical Trials 80
- Clinical Trials Metrics Collection 81
- Chapter 7 Performing Electronic Clinical Trials in Accord with Regulations 91
- Agency Aim in Creating 21 CFR 11 92
- Regulatory Considerations in Planning an Electronic Clinical Trial 94
- Regulatory Considerations While Executing an Electronic Clinical Trial 100
- Chapter 8 Data Quality and Data Integrity 108
- Error Sources 109
- Chapter 9 The Impact of eClinical Trial Technology on Safety Surveillance and IRBs 114
- Time Delay 115
- Responsibilities for Monitoring Patient Safety 115
- Patient Privacy 121
- Chapter 10 Industry Data Standards: Ensuring the Success of Electronic Clinical Trial Implementations 124
- The Value of Standards 125
- The CDISC Operational Data Model 130
- Further Progress on Clinical Data Standards 132
- Appendix D Traceability Matrix 156
- Appendix E 21 CFR Part 11 163
- Appendix F Guidance for Industry: Computerized Systems Used in Clinical Trials [CSUCT] 171.
- Notes:
- Includes bibliographical references (pages 137-138).
- ISBN:
- 193062428X
- OCLC:
- 52854256
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