
Writing Clinical Research Protocols
Ethical Considerations
Description
Key Features
- Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol
- Includes a chapter containing Case Histories
- Contains information on conducting clinical research within the pharmaceutical industry
- An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations
- Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Readership
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
- 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
- Procedures and Methods
- Statistics, Data Collection and Management, and Record Keeping
- Use of Human Biological Materials
- Special Issues Raised by Evolving Areas of Clinical Research
- Case Histories: Learning From Experience
Section II. Preparing the Protocol
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
Section IV. Special Issues
Appendix: Web Resources
References
Glossary
Index
Product details
- No. of pages: 320
- Language: English
- Copyright: © Academic Press 2005
- Published: August 4, 2005
- Imprint: Academic Press
- Paperback ISBN: 9780122107511
- eBook ISBN: 9780080454207
About the Authors
Evan DeRenzo
Affiliations and Expertise
Joel Moss
Affiliations and Expertise
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