A Comprehensive and Practical Guide to Cli...

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Beschreibung

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.

Zusammenfassung

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.

Inhaltsverzeichnis

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

Details

Erscheinungsjahr:	2017
Fachbereich:	Toxikologie
Genre:	Importe , Medizin
Rubrik:	Wissenschaften
Medium:	Taschenbuch
ISBN-13:	9780128047293
ISBN-10:	0128047291
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Redaktion:	Shamley, Delva Wright, Brenda
Hersteller:	Elsevier Science
Verantwortliche Person für die EU:	Zeitfracht Medien GmbH, Ferdinand-Jühlke-Str. 7, D-99095 Erfurt, produktsicherheit@zeitfracht.de
Maße:	154 x 228 x 14 mm
Von/Mit:	Delva Shamley (u. a.)
Erscheinungsdatum:	11.06.2017
Gewicht:	0,34 kg