Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well-organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data. Table of Contents Part I: The Business of Research Chapter 1: The Cancer Problem Chapter 2: The Protocol Process Chapter 3:Regulatory Issues Chapter 4: The Budget Chapter 5: The Contract Part II: Setting the Foundation Chapter 6: Initiating the Protocol Chapter 7: Preparing for Treatment Part III: The Clinical Side Chapter 8: The Enrollment Process Chapter 9: Treating the Patient Chapter 10: Pharmacokinetic Sampling Part IV: The Data Side Chapter 11: Data Collection Chapter 12: The Monitoring Process Chapter 13: Closing the Study Part V: Organizational Issues Chapter 14: Organizing a Research Program Chapter 15: Standard Operating Procedures