This book is a complete guide for anyone involved in clinical trials or for the novice who is looking to join this field. Including comprehensive appendices, this practical manual reveals valuable industry secrets to help medical professionals discover how to attract drug companies to a site; land a study on good terms; and demystify regulatory requirements. Now this book has been completely revised to incorporate changes in the rapidly shifting global drug development industry. New topics include new regulations affecting research, subject injury clauses, legal and publication land mines, the unique needs of device and vaccine trials, the impact of HIPAA on U.S. research, cultural competency and health literacy, how to survive audits, and the use of social media to recruit volunteers.