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A Comprehensive and Practical Guide to Clinical Trials Summary

A Comprehensive and Practical Guide to Clinical Trials by Delva Shamley (Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa)

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end.

About Delva Shamley (Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa)

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.

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

Additional information

GOR011836996
9780128047293
0128047291
A Comprehensive and Practical Guide to Clinical Trials by Delva Shamley (Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa)
Used - Very Good
Paperback
Elsevier Science Publishing Co Inc
2017-06-11
210
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
This is a used book - there is no escaping the fact it has been read by someone else and it will show signs of wear and previous use. Overall we expect it to be in very good condition, but if you are not entirely satisfied please get in touch with us

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