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Automating the Creation of Data Definition Tables (Define.pdf) Using SAS® Version 8.2
| Content Provider | Semantic Scholar |
|---|---|
| Author | Kasichainula, Syamala Lanier, Katie |
| Copyright Year | 2003 |
| Abstract | One component of an electronic NDA submission to the FDA is the metadata file Define.pdf, which contains documentation of Case Report Tabulation (CRT) datasets. This file contains a list of dataset names and their descriptions and location. For each dataset, a list of variables and their associated attributes (e.g. length, label, format name, list of decoded values, etc...) are described. Prior efforts to automate the creation of Define.pdf using a SAS version 6.12 program had limitations in handling large text fields and the PDF file format. We have made enhancements to Define.pdf, including the addition of new SAS variable attributes, as well as automating the inclusion of a generic text comment field, used to display the variable source and the definition of derived variables. We used the Output Delivery System (ODS) in SAS version 8.2 and its capability to handle large text values (over 200 characters) such as derived variable definitions and lists of decoded values to directly generate Define.pdf from a SAS program. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://www.lexjansen.com/pharmasug/2003/FDACompliance/fda018.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
