Writing Clinical Research Protocols
Ethical Considerations
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Product details:
- Publisher Elsevier Science
- Date of Publication 8 September 2005
- ISBN 9780122107511
- Binding Paperback
- No. of pages320 pages
- Size 229x152 mm
- Weight 520 g
- Language English 0
Categories
Long description:
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.
MoreTable of Contents:
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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
" More
