Hardly a week goes by without a newspaper headline or an evening news report detailing a mishap or scandal in the world of clinical research. An increasingly informed public demands speedy breakthroughs in treatment while eyeing warily the risks of participation in clinical trials. The nations most prestigious medical centers suffer record fines for research misconduct and the embarrassment that goes with it. Against this backdrop those in the trenches of clinical research work under heightening pressure and scrutiny. More than ever this field demands an unprecedented level of knowledge and understanding. Clinical Research: What It Is and How It Works will provide you with a fundamental yet comprehensive understanding of all phases of the clinical research process. Every aspect of clinical research from program design, regulatory issues, ethical considerations, to IRB roles and functions, quality controls, financial management, and more are explained in clear, concise language. Whether you are a seasoned researcher or a brand new member of an IRB, this book will provide a clear, thorough perspective on the clinical research process.