Writing Clinical Research Protocols

Writing Clinical Research Protocols : Ethical Considerations

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This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.
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Product details

  • Paperback | 320 pages
  • 149.9 x 226.1 x 20.3mm | 512.57g
  • Academic Press Inc
  • San Diego, United States
  • English
  • 0122107519
  • 9780122107511
  • 1,150,179

Review quote

"This book will be a very useful text and reference source for students and trainees at all levels..."
- JAMA (February 2006)
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Table of contents

Section I. The Basics: What You Need to Know Before Starting Human Subjects Research

Introduction to the Art and Science of Clinical Research
What You Need to Know About Clinical Research Ethics
What You Need to Know About the Regulation of Clinical Research
Section II. Preparing the Protocol

Designing a Clinical Research Study
Selecting Subjects for Clinical Studies
Risks and Benefits in Clinical Research
Recruiting Subjects
Informed Consent
Privacy and Control
The "Ethics" Section
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping

Procedures and Methods
Statistics, Data Collection and Management, and Record Keeping
Section IV. Special Issues

Use of Human Biological Materials
Special Issues Raised by Evolving Areas of Clinical Research
Case Histories: Learning From Experience

Appendix: Web Resources



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About Evan DeRenzo

By Dr. Evan DeRenzo and Dr. Joel Moss
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