This is a step-by-step how-to manual for both experienced medical professionals and novices looking to enter the field of clinical studies. The book explains how to land a study on good terms. It provides tips for recruiting patient volunteers - and keeping them happy. It offers easy strategies for co-ordinating studies. It demystifies regulatory requirements. With a comprehensive index and appendices, this book has been adopted by university health sciences programs across the country. The first edition was a Ben Franklin Awards 2007 Finalist and a 2007 Finalist in "ForeWord Magazine"'s reference category for professional/technical books. New, expanded, and completely updated sections keep readers abreast of changes in the rapidly shifting global drug development industry, including new regulations affecting research, subject injury clauses, the unique needs of device and vaccine trials, the impact of HIPAA on U.S. research, cultural competency and health literacy, ethical considerations in clinical research, and how to survive audits.