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Writing Clinical Research Protocols
Ethical Considerations
1st Edition - August 4, 2005
Authors: Evan DeRenzo, Joel Moss
Language: English
Paperback ISBN:9780122107511
9 7 8 - 0 - 1 2 - 2 1 0 7 5 1 - 1
eBook ISBN:9780080454207
9 7 8 - 0 - 0 8 - 0 4 5 4 2 0 - 7
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…Read more
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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.
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
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.
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
No. of pages: 320
Language: English
Edition: 1
Published: August 4, 2005
Imprint: Academic Press
Paperback ISBN: 9780122107511
eBook ISBN: 9780080454207
ED
Evan DeRenzo
Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA
Affiliations and expertise
Center for Ethics, Washington Hospital Center, Washington, DC, USA
JM
Joel Moss
National Institutes of Health, Bethesda, MD, USA
Affiliations and expertise
National Institutes of Health, Bethesda, MD, USA
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