Writing clinical research protocols : ethical considerations

著者

書誌事項

Writing clinical research protocols : ethical considerations

Evan G. DeRenzo and Joel Moss

Elsevier Academic Press, c2006

  • : pbk

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注記

Includes bibliographical references (p. 273-280) and index

Includes web resources

内容説明・目次

内容説明

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.

目次

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

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