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Writing Clinical Research Protocols : Ethical Considerations - Evan DeRenzo

Writing Clinical Research Protocols

Ethical Considerations

By: Evan DeRenzo (Editor), Joel Moss (Editor)


Published: 8th September 2005
Format: PDF
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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. It 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 will be 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

What You Need To Know About Research Ethics Before Deciding on What You Want To Study
Designing a Clinical Research Study
Writing Consent and Assent Documents
Getting the Protocol Approved
Conducting the Study; Special Populations
Ethical Considerations in Genetics Research
Ethical Considerations in Use of Tissue for Laboratory Investigations
Ethical Considerations in Use of Stored Tissue
Confidentiality Issues
Research in Emergency Medicine
Reporting of Adverse Events
Radiation Safety Issues
Participation of Subjects in Multi-Site Trials
Participation of Subjects in Multiple Studies
Conduct of Pharmaceutical Industry Research
Case Histories, Learning from Experience

ISBN: 9780080454207
ISBN-10: 0080454208
Format: PDF
Language: English
Number Of Pages: 320
Published: 8th September 2005
Publisher: Elsevier Science