chapter 1 Overview and Elements of Clinical Research -- chapter 2 The Physician as Investigator -- chapter 3 Professional Interactions -- chapter 4 FDA Regulations and Good Clinical Practice Guidelines -- chapter 5 Investigational Agent Management -- chapter 6 Designing a Study and Protocol Development -- chapter 7 The Informed Consent Process -- chapter 8 Conducting the Study -- chapter 9 Monitoring of Clinical Trials -- chapter 10 Interactions with the Study Subject -- chapter 11 Adverse Events and Drug Safety -- chapter 12 Data Management -- chapter 13 The Study Results -- chapter 14 Audits of Clinical Research Sites -- chapter A: FDA Regulations -- chapter B: FDA Information Sheets -- chapter C Protection of Human Subjects: Declaration of Helsinki -- chapter Glossary of Terms -- chapter Abbreviations.