A comprehensive and practical guide to clinical trials /
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| Altri autori: | , |
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| Natura: | Libro |
| Lingua: | English |
| Pubblicazione: |
London, United Kingdom ; San Deigo, CA, United States :
Elsevier/AP, Academic Press, an imprint of Elsevier,
[2017]
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Sommario:
- Introduction to clinical trials / Brenda Wright
- Clinical trial phases / Brenda Wright
- Setting up of site, site assessment visits, and selection / Brenda Wright
- Regulatory requirements / Inge Vermeulen
- Contracts and agreements / Brenda Wright
- Protocol, informed consent documents, and investigator brochure / Brenda Wright
- Planning / Brenda Wright
- Recruitment and retention / Brenda Wright
- Training / Brenda Wright
- Data management / Annemie Stewart
- Investigational medicinal product (IMP) management / Wynand Smythe and Nicky Kramer
- Collecting, processing, and shipment of blood and urine samples / Brenda Wright
- Source document / Brenda Wright
- Screening, treatment, and safety follow-up visit / Brenda Wright
- Quality management / Brenda Wright
- Monitoring, close-out visits, and archiving / Brenda Wright
- Audits and inspections / Brenda Wright.