A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /
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| Format: | Livre |
| Langue: | English |
| Publié: |
Chichester, West Sussex, UK ; Hoboken, NJ :
Wiley-Blackwell,
2010.
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| Édition: | 2nd ed. |
| Sujets: | |
| Accès en ligne: | Publisher description Table of contents only Contributor biographical information |
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Table des matières:
- Lessons from a horse named Jim and other events in history affecting the regulation of clinical research
- The process : developing new drugs, biologics, and devices
- Good clinical practice and the regulations
- Informed consent and the regulations
- Institutional review boards
- Adverse events and unanticipated problems involving risks to subjects and others
- Monitoring, audits, and inspections
- The principal investigator, the clinical research coordinator, and the study site
- The protocol
- Study feasibility : reviewing a specific protocol
- Study activities
- Study documents/essential documents
- Management of study drugs, biologics, and devices
- Managing clinical trial data
- Global health and international trials.