Full 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.
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
