According to Janet Stuelpner and Joseph Hantsch, the authors of the 2012 SAS Global Forum paper, One at a Time; Producing Patient Profiles and Narratives, patient profiles are used several ways depending upon the 'customer' need.
In their paper, Stuelpner and Hantsch discuss two types of patient profiles (a basic data dump and a narrative), identify customer types and associated needs, and briefly describe the type of software that could be used (Base SAS, SAS Enterprise Guide or JMP Clinical). In the video, Stuelpner walks you through the poster and takes a moment to explain which scenario might prompt you to use Base SAS, SAS Enterprise Guide or JMP Clinical.
Stuelpner and Hantsch's paper is not the only paper in the SAS Global Forum 2012 proceedings related to clinical trial data and FDA submissions. Also take a look at:
- A Standard SAS® Program for Corroborating OpenCDISC Error Messages
- Examples of Building Traceability in CDISC ADaM Datasets for FDA Submission
The PharmaSUG conference is a SAS Users Group event usually held in May. The conference focuses on applying SAS to the challenges of the pharmaceutical and healthcare industry, understanding issues related to FDA regulatory compliance, and exploring emerging industry standards like CDISC, SDTM and ADaM. Sign up for the PharmaSUG newsletter and watch this blog for announcements about the 2013 conference.