Evaluation of the IT Infrastructure of the RESIST Study with the Evidence-Based CIPROS Checklist.

Efficient and powerful information systems are substantial to perform medical research projects successfully. Especially, translational medicine poses specific challenges to the corresponding IT infrastructure. The RESIST study is a translational research project in oncology where xenografts inform about patients second-line treatment. DBFORM, an in-house developed system, was used as EDC system. It was enhanced with project specific features. We demonstrate how the CIPROS checklist has the potential to optimize the related requirements engineering process. The CIPROS checklist consists of 72 items, organized within 12 Aspects/Topics and was developed to assess such patient registry software systems. In this paper we use the CIPROS checklist (1) to elucidate the projects requirements and (2) to assess systems features. The application of the CIPROS checklist to fix the RESIST project requirements and system features was successful. The interplay between (1) and (2) helped to accelerate the requirements engineering process and to set up a system suitable to perform the translational research project successful.