The CRC"s Guide to Coordinating Clinical Research has been one of the foremost training tools and reference guides for novice and experienced coordinators since the first edition was released in 2004. Now with new chapters on investigational product accountability, device and biologics trials and data safety monitoring boards, along with key takeaways and newly added case studies, The CRC"s Guide is the most comprehensive resource available for on-site training staffs, professors or individuals interested in a step-by-step approach to coordinating successful clinical trials. Topics include: -A comprehensive review of CRC roles and responsibilities -Understanding regulations and GCPs -Preparing for a study -Working with study subjects -The informed consent process -Case report forms and EDC -Study closure -The future outlook -Job descriptions and current academic programs -Adverse Events and Safety Monitoring -Sample Forms, Checklists and Logs Recommended for: -Novice and experienced CRCs -Health professionals interested in pursuing a career as a study coordinator -Instructors conducting training and educational programs