A Comprehensive and Practical Guide to Clinical Trials

Häftad, Engelska, 2017

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Beskrivning

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.

Describes the entire clinical trial management process from start to finish in a step-by-step guide
Provides best practice elements, including case studies, practical examples, activities, and checklists

Produktinformation

Utgivningsdatum:2017-06-11
Mått:152 x 229 x 14 mm
Vikt:340 g
Format:Häftad
Språk:Engelska
Antal sidor:210
Förlag:Elsevier Science
ISBN:9780128047293

Utforska kategorier

Farmakologi inom Medicin
Medicinsk utrustning och medicinska tekniker inom Medicin

Mer om författaren

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.

Innehållsförteckning

1. Introduction to Clinical Trials2. Clinical Trial Phases3. Site Set-up, Assessment visits and Selection4. Regulatory Requirements5. Contracts6. Protocol, Investigator Brochure and Informed Consent Documents7. Planning8. Recruitment9. Training10. Data Management11. Pharmacy12. Transit Laboratory13. Screening, Treatment and Follow-up Visits14. Quality checks, Monitoring and Preparing for Audits15. Close-out of Trial and Archiving