A Comprehensive and Practical Guide to Clinical Trials

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. Content: Front-matter,Copyright,List of Contributors,ForewordEntitled to full textChapter 1 - Introduction to Clinical Trials, Pages 1-9, Brenda Wright Chapter 2 - Clinical Trial Phases, Pages 11-15, Brenda Wright Chapter 3 - Setting Up of Site, Site Assessment Visits, and Selection, Pages 17-26, Brenda Wright Chapter 4 - Regulatory Requirements, Pages 27-42, Inge Vermeulen Chapter 5 - Contracts and Agreements, Pages 43-47, Brenda Wright Chapter 6 - Protocol, Informed Consent Documents, and Investigator Brochure, Pages 49-58, Brenda Wright Chapter 7 - Planning, Pages 59-79, Brenda Wright Chapter 8 - Recruitment and Retention, Pages 81-86, Brenda Wright Chapter 9 - Training, Pages 87-90, Brenda Wright Chapter 10 - Data Management, Pages 91-102, Annemie Stewart Chapter 11 - Investigational Medicinal Product (IMP) Management, Pages 103-117, Wynand Smythe, Nicky Kramer Chapter 12 - Collecting, Processing, and Shipment of Blood and Urine Samples, Pages 119-125, Brenda Wright Chapter 13 - Source Document, Pages 127-132, Brenda Wright Chapter 14 - Screening, Treatment, and Safety Follow-up Visit, Pages 133-154, Brenda Wright Chapter 15 - Quality Management, Pages 155-173, Brenda Wright Chapter 16 - Monitoring, Close-Out Visits, and Archiving, Pages 175-179, Brenda Wright Chapter 17 - Audits and Inspections, Pages 181-183, Brenda Wright Glossary, Pages 185-187 Index, Pages 189-196