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Writing Clinical Research Protocols
Evan DeRenzo and Joel Moss
Academic Press
September 2005
Paperback 320 pp ISBN 0122107519
£25.00
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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
- Numerous flowcharts summarize good work practice
- Includes a chapter containing Case Histories
- Excellent internet resources are included in the appendix
- Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical
considerations explicitly address biostatistical considerations
A practical guide for clinical researchers that aims to improve their skills in the understanding of the
ethical requirements for the design and conduct of clinical research. Includes 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.
Appendices include internet resources, grant writing tips, as well as advice on subject recruitment and budget
considerations.
Readership: 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.
Contents
- Introduction;
- What You Need To Know About Research Ethics Before Deciding on What You Want To Study;
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- Designing a Clinical Research Study;
- Writing Consent and Assent Documents;
- Getting the Protocol
Approved;
- Conducting the Study;
- Special Populations;
- Ethical Considerations in Genetics Research;
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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;
- FDA;
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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;
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Appendices.
To find similar publications, click on a keyword below:
Academic Press
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