Queries management: Interfacing SAS with in-house EDC

Despite the growing use of EDC by pharmaceutical companies in clinical trials and the confirmed leverage of this technology, off-line edit checks for data validation are still widely used. SAS®, mainly due to its flexibility, is therefore an appealing alternative for their implementation. The management of generated queries is, however, usually a high hurdle to overcome, particularly in large multicenter studies. Most EDC applications on the other hand offer full user friendly possibilities for manual queries management by the monitor. In this paper we will show how we successfully interfaced our SASworkflow for automatic queries generation with our inhouse EDC application, thus enabling to combine the advantages of both sides for the efficient management of off-line queries