Herein, we briefly review the content and conversion of datasets to SAS transport file format, and then elaborate on the code that makes easy work of theaccompanying dataset documentation (in the form of data definition tables) using the SAS Output Delivery System (ODS). CRTs are made up of two parts: first, datasets inSAS® transport file format and second, the accompanying documentation for the datasets. As described, one important part of the application package is the case report tabulations (CRTs), now serving as the instrument for submitting datasets. In January 1999, the FDA released the Guidance for Industry: Providing Regulatory Submissions in Electronic Format – NDAs. Electronic submissions could help FDA application reviewers scan documents efficiently and check analyses by manipulating the very datasets and code used to generate them.The potential saving in reviewer time and cost is enormous while improving the quality of oversight. ABSTRACT:The Food and Drug Administration (FDA) now strongly encourages all new drug applications (NDAs) be submitted electronically.
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