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A Comprehensive and Practical Guide to Clinical Trials


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A quick reference guide with tools and case studies that enable effective planning and implementation of clinical trials

Table of Contents

1. 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 Archiving

About the Author

Dr 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.

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