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A Comprehensive and Practical Guide to Clinical Trials

  • 1st Edition - June 7, 2017
  • Latest edition
  • Editors: Delva Shamley, Brenda Wright
  • Language: English

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 th… Read more

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Description

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.

Key features

  • 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

Readership

Clinical research teams from academia and industry across the globe, including study coordinators, project managers, clinical support staff, investigators, data managers and data quality assurance managers

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 & Follow-up Visits
  14. Quality checks, Monitoring & Preparing for Audits
  15. Close-out of Trial and Archiving

Product details

  • Edition: 1
  • Latest edition
  • Published: June 7, 2017
  • Language: English

About the editors

DS

Delva Shamley

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.
Affiliations and expertise
Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa

BW

Brenda Wright

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.
Affiliations and expertise
Operations Manager: Pharma-Lead Projects, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa

View book on ScienceDirect

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