Table of Contents

Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson

Chapter 2
It Takes a Village to Conduct a Clinical Trial

Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases

Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials

Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee

Chapter 6
Be Informed About Informed Consent

Chapter 7
Practical Advice for Following Good Clinical Practice

Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial

Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial

Chapter 10
The Subject of Recruitment and Retention

Chapter 11
The Investigational Compound - Like Handling Kryptonite

Chapter 12
Budgets and Contracts - Show Me the Money

Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation

Chapter 14
Audits/Inspections - Be Prepared for Anything

Chapter 15
Conducting Clinical Trials Without Ending Up on Trial