Creating Define.pdf with SAS® Version 9.3 ODS RTF

It is becoming more common for regulatory submissions to include define.xml – the data definition documents for Study Data Tabulations Model (SDTM) data, Analysis Data Model (ADaM) data, and even legacy data.  Although define.xml documents can help regulatory reviewers to navigate submission datasets, documents and variable derivations, they usually do not print out properly on paper.  One solution is to generate a define.pdf document with the same content as the define.xml.  The portable document format (PDF) file includes bookmarks and hyperlinks to facilitate online review, and it can also be printed out for hardcopy review.  Providing define.pdf documents can help sponsors remove obstacles to the review of their regulatory submissions.

This paper presents tips for using SAS® Version 9.3 Output Delivery System (ODS) rich text format (RTF) to generate an RTF file, and then use Acrobat’s PDF Maker to convert it to a define.pdf document.  It discusses reasons for the use of ODS RTF instead of ODS PDF.  It demonstrates how to create a user-defined style using SAS® PROC TEMPLATE.  It shows how to use RTF code to set up bookmarks and hyperlinks to internal as well as external locations.  It provides examples of using other RTF code to improve formatting of the RTF document.  The features of bookmarks, hyperlinks, headings, and other formatting details are important to an online review of any document.