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OverviewFull Product DetailsAuthor: Delva Shamley (Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa) , Brenda Wright (Operations Manager: Pharma-Lead Projects, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa)Publisher: Elsevier Science Publishing Co Inc Imprint: Academic Press Inc Weight: 0.340kg ISBN: 9780128047293ISBN 10: 0128047291 Pages: 210 Publication Date: 11 June 2017 Audience: Professional and scholarly , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: Manufactured on demand  We will order this item for you from a manufactured on demand supplier. Table of Contents1. Introduction to Clinical Trials 2. Clinical Trial Phases 3. Site Set-up, Assessment visits and Selection 4. Regulatory Requirements 5. Contracts 6. Protocol, Investigator Brochure and Informed Consent Documents 7. Planning 8. Recruitment 9. Training 10. Data Management 11. Pharmacy 12. Transit Laboratory 13. Screening, Treatment and Follow-up Visits 14. Quality checks, Monitoring and Preparing for Audits 15. Close-out of Trial and ArchivingReviewsAuthor InformationDr Delva Shamley is a South African graduate and has been in academia for 26 years, 13 of which were spent in the UK. Her training and experience of clinical research comes from Oxford NHS and the Centre for Medical Statistics, Oxford University, UK. Delva has been training and supporting clinicians in Research Methods for many years. She returned to Cape Town in 2011 and started as Deputy Director of the UCT CRC in October of 2013. She has since been appointed as the Director for CRC. Brenda Wright (Registered Nurse/Medical Technician) started her career in Research at an Early Phase Unit in George in 2005. There she gained experience as study coordinator, Manager Clinical Planning, Manager Transit Laboratory and Clinical Trial Assistants. Experience includes: Healthy Volunteer, Bio-equivalent, First into Human, Restless Legs, Parkinson’s disease, Alzheimer’s disease, Schizophrenia, Diabetes, COPD, Asthma, Osteo Arthritis, Rheumatoid arthritis, various skin diseases, TB, HIV, Sickle Cell in children and adolescents and Cancer. Brenda joined the CRC in April 2014 as Project Manager and the Research Facility Ward Manager. She has since been appointed as Operations Manager: Pharma-Lead Projects. Tab Content 6Author Website:Countries AvailableAll regions |
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