Writing Clinical Research Protocols
Academic Press Inc (Verlag)
978-0-12-210751-1 (ISBN)
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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.
Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA National Institutes of Health, Bethesda, MD, USA
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
References
Glossary
Index
| Erscheint lt. Verlag | 8.9.2005 |
|---|---|
| Verlagsort | San Diego |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 520 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete |
| ISBN-10 | 0-12-210751-9 / 0122107519 |
| ISBN-13 | 978-0-12-210751-1 / 9780122107511 |
| Zustand | Neuware |
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