A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (CDISC v 9.0). The appropriate format and content of the report is defined in ICH E3, and appendices should include the study protocol, sample case report forms, investigator related information, information related to the investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output etc.
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