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A comprehensive and practical guide to clinical trials / edited by Delva Shamley, Brenda Wright, The Clinical Research Centre of Cape Town, Cape Town, Western Cape Province, South Africa.

Contributor(s): Shamley, Delva [editor.] | Wright, Brenda [editor.].
Publisher: London, United Kingdom ; San Deigo, CA, United States : Elsevier/AP, Academic Press, an imprint of Elsevier, [2017]Copyright date: ©2017Description: xiv, 196 pages : illustrations ; 23 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9780128047293.Subject(s): Clinical trials -- Handbooks, manuals, etc | Clinical Trials as Topic | Clinical trialsGenre/Form: Print books.
Contents:
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.
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Includes bibliographical references and index.

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.

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