Issue Date: July 1, 1988
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Format and Content of the Clinical and Statistical Sections of an Application
This guideline is intended to assist an applicant in presenting the clinical and statistical data required as part of an application under 21 CFR 314.50. The guideline describes an acceptable format for organizing the clinical and statistical sections and presenting the clinical and statistical information and accompanying statistical documentation of a clinical trial. With respect to documenting the results of individual studies, the guideline describes a fully integrated clinical and statistical report rather than two separate reports.
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