Beschreibung:
<jats:title>Abstract</jats:title><jats:p>Background Registries are an essential research tool to investigate the long-term course of diseases and their impact on the affected. The project digiDEM Bayern will set up a prospective dementia registry to collect long-term data of people with dementia and their caregivers in Bavaria (Germany) supported by more than 300 research partners.</jats:p><jats:p>Objective The objective of this article is to outline an information technology (IT) architecture for the integration of a registry and comprehensive participant management in a dementia study. Measures to ensure high data quality, study governance, along with data privacy, and security are to be included in the architecture.</jats:p><jats:p>Methods The architecture was developed based on an iterative, stakeholder-oriented process. The development was inspired by the Twin Peaks Model that focuses on the codevelopment of requirements and architecture. We gradually moved from a general to a detailed understanding of both the requirements and design through a series of iterations. The experience learned from the pilot phase was integrated into a further iterative process of continuous improvement of the architecture.</jats:p><jats:p>Results The infrastructure provides a standardized workflow to support the electronic data collection and trace each participant's study process. Therefore, the implementation consists of three systems: (1) electronic data capture system for Web-based or offline app-based data collection; (2) participant management system for the administration of the identity data of participants and research partners as well as of the overall study governance process; and (3) videoconferencing software for conducting interviews online. First experiences in the pilot phase have proven the feasibility of the framework.</jats:p><jats:p>Conclusion This article outlines an IT architecture to integrate a registry and participant management in a dementia research project. The framework was discussed and developed with the involvement of numerous stakeholders. Due to its adaptability of used software systems, a transfer to other projects should be easily possible.</jats:p>