This newly updated edition of the benchmark guide to computer–assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting. Keeping the same user–friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e–submission procedures and computerized direct data acquisition. The new 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...

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