A comprehensive and practical guide to clinical trials /

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Detalles Bibliográficos
Otros Autores: Shamley, Delva (Editor ), Wright, Brenda (Editor )
Formato: Libro
Lenguaje:English
Publicado: London, United Kingdom ; San Deigo, CA, United States : Elsevier/AP, Academic Press, an imprint of Elsevier, [2017]
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Tabla de Contenidos:
  • 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.