Assisting principle investigators perform risk assessments of their clinical trials, this book identifies the typical threats and opportunities encountered in clinical trials and provides a systematic methodology for analyzing them. The book comprises ten stand-alone chapters, taking the reader from basic principles to specific methods. Written in an easy-to-read style, including anecdotal explanations and practical suggestions, the book contains diagrams, Risk and PrecisionTree charts, and graphics that reinforce the concepts covered in the text. The format is a discussion of concepts followed by worked examples and each chapter closes with a list summarizing the main points covered.