This book features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. This edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards. This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections - 'Plan', 'Do', and 'Check' - include the following material - Should the trials be conducted?; Put it in the computer and keep it there; Staffing for success; Designing trials and determining sample size; Budgeting; Recruiting and retaining patients and physicians; Data management; Monitoring the trials; Data analysis; After action review; Exception handling; Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource.