Writing clinical research protocols : ethical considerations / / Evan G. DeRenzo and Joel Moss.
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| Year of Publication: | 2006 |
| Language: | English |
| Online Access: | |
| Physical Description: | xix, 300 p. |
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Table of Contents:
- 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
- Designing a clinical research study
- Selecting subjects for clinical studies
- Risks and benefits in clinical research
- Recruiting subjects
- Informed consent
- Privacy and confidentiality
- The "ethics" section
- Procedures and methods
- Statistics, data collection and management, and record keeping
- Use of human biological materials
- Special issues raised by evolving areas of clinical research
- Case histories : learning from experience.