Clinical trials and human research : a practical guide to regulatory compliance /
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| Format: | Book |
| Language: | English |
| Published: |
San Francisco :
Jossey-Bass,
[2003]
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| Edition: | First edition. |
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Table of Contents:
- Evolution of human experimentation regulation
- Current federal regulations and agencies involved in human research
- State regulation of human research
- Selection and recruitment of research subjects
- Informed consent in clinical trials
- Confidentiality of clinical trials information
- The investigator
- Research protocols
- Institutional review board
- Patient safety in clinical trials research
- Human research under the food, drug & cosmetic act
- Behavior research
- Multisite and collaborative studies
- Medical malpractice liability in human research
- Quality improvement, accreditation, and risk management in clinical trials
- Corporate compliance and human research
- Ethics in human research
- International research