This book is intended to begin to fill this gap as a resource containing information and reference material to help identify and understand the legal issues, many of which are quite complex, that are associated with clinical trials. This book is limited to American law, and it is beyond its scope to discuss the legal aspects of international clinical trials, which is a topic deserving of a book unto itself.3 On many occasions the author of this book has needed to consult a comprehensive review of clinical trial law but could find only one book that came close—Clinical Research Law and Compliance Handbook.4 It provides an excellent and practical overview of regulatory and compliance requirements in structuring a clinical trial, but does not deal with clinical issues raised during the conduct of such trials to the extent this book does. The current book, on the other hand, provides an overview of relevant regulatory schemes and emphasizes and integrates into the reading cases involving the clinical aspects of trials. As such, the work will be a resource/ research aid handbook designed more for clinical investigators, their institution administrators, and counsel.