A Concept for a Data Dictionary System Supporting for Clinical Research.

Clinical trials form the backbone of evidence-based medicine. They are indispensable tools that make it possible to compare medical interventions or test medical devices for their efficacy and safety. Each study design exactly defines which data is to be collected. Case report forms (CRFs) are used to document the collected data. Preparing CRFs is complicating, time consuming and requires extensive knowledge in the fields of medicine, data management and statistics. In addition, there are no global standards for CRF design, which means that each research institution produces CRF data definitions at its own discretion. This hampers the exchange of data definitions among different research groups and variants of CRFs might be created for a similar study design. To address these problems, we developed a concept for a freely accessible portal in the form of a web application in which definitions for CRFs, variables and tables can be created. The created data definitions can be exported from the portal to be transferred to common electronic data capture systems (EDC) that can then generate CRFs using the definition. The overall objective of the project is to develop a data dictionary system that is used during the entire workflow of a study and that enables sharing and re-use of metadata.