Physician Investigator Handbook

A comprehensive guide for physicians conducting clinical research this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines current FDA regulations and an Internet address directory. Everything the clinical trial manager planner monitor and investigator need to know about the design establishment monitoring and close-out of a trial is in this book. The chapters address the elements of clinical research professional interactions FDA regulations and good clinical practices guidelines investigational agent management designing a study and protocol development conducting the study and more.