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Overview MedXview DefinePDFcreator™ is the most efficient application to automatically create the define.pdf file with all elements for E-Submission. Data Definition Table (define.pdf) is one of the elements of a successful FDA electronic submission. It was defined in Item 11 in the November 1999 version of “Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER or CDER) in Electronic Format – Biologics Marketing Applications.”    Features Creates a table for all datasets that includes all dataset names, description of the datasets, and location. Simultaneously creates three kinds of hypertext links in the first table of define.pdf: A hypertext link from the description of the dataset to the appropriate data definition table. A hypertext link from the location listing of the file to the SAS transport file. A hypertext link to the appropriate annotated case report form files  (BlankCRF.pdf) . Creates a table for each dataset that includes all the variables, variable label, variable type, variable code, and variable comments. Creates derived variables with the method for calculating the variable included in the comments field. Creates row variables with the location of the variable on the annotated CRF and the CRF field name if different from the variable name in the dataset. Creates required hypertext link from each raw data variable in the data definition table to the appropriate location of the BlankCRF.pdf. Creates an alphabetic list of all variables in the study datasets and the dataset(s) in which each can be found. Adds all required navigational tools, such as bookmarks and links as described in the guidelines. Delivers the necessary standardization in an automated tool.  Download