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A comprehensive and practical guide to clinical trials / edited by Delva Shamley, Brenda Wright, The Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa. - xiv, 196 pages : illustrations ; 23 cm

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.

ISBN: 9780128047293 0128047291

LCCN: 2017936521

Subjects--Topical Terms:
Clinical trials--Handbooks, manuals, etc.
Clinical Trials as Topic.
Clinical trials.

Index Terms--Genre/Form:
Handbooks and manuals.

LC Class. No.: R853.C55 / C665 2017

Dewey Class. No.: 615.5072/4

National Library of Medicine Call No.: W 20.55.C5