Quality Assurance: Best Practices in Clinical SAS® Programming

SAS® programmers working on clinical reporting projects are often under constant pressure of meeting tight timelines, producing best quality SAS® code and of meeting needs of customers. As per regulatory guidelines, a typical clinical report or dataset generation using SAS® software is considered as software development. Moreover, since statistical reporting and clinical programming is a part of clinical trial processes, such processes are required to follow strict quality assurance guidelines. While SAS® programmers completely focus on getting best quality deliverable out in a timely manner, quality assurance needs often get lesser priorities or may get unclearly understood by clinical SAS® programming staff. Most of the quality assurance practices are often focused on ‘process adherence’. Statistical programmers using SAS® software and working on clinical reporting tasks need to maintain adequate documentation for the processes they follow. Quality control strategy should be planned prevalently before starting any programming work. Adherence to standard operating procedures, maintenance of necessary audit trails, and necessary and sufficient documentation are key aspects of quality. This paper elaborates on best quality assurance practices which statistical programmers working in pharmaceutical industry are recommended to follow. These quality practices are directly referred from the regulatory guidance and are illustrated with examples in this manuscript.