This book explains how to design and utilize data collection forms to obtain complete and accurate data in clinical trials and provides a library of designed forms that can be modified for a specific clinical trial. The first part of the book offers guidelines on choosing modules, designing forms, preparing the data collection form package, reproducing and assembling forms, using remote date entry forms and data processing and storage of completed forms. The authors then provide examples of data collection forms for every type of data needed in a clincial trial, including times and events schedules; demographics; medical histories; inclusion and exclusion criteria, vital signs; physical examinations; psychological and psychiatric tests; laboratory tests; radiology and pathology reports; dosing and dispensing of drugs; assays of biological levels; efficacy; compliance; patient diaries; patient termination and global clinical impressions.
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