Figure 1

The Trusted Third Party (TTP) is a core element in a research data management infrastructure: After provision of a system-wide unique identifier for the study participant (identity management), the TTP stores the Informed Consent Document (IC) and provides the required pseudonyms (PSN) for data capture. The participants identifying data (IDAT) is stored within the TTP. Pseudonymised medical data (MDAT) and related metadata are stored in the research platform. The usage of (pseudonymised) medical data typically includes quality assurance, reporting and analysis. If the participant consented to the secondary use of his medical data, data may be provided for further research projects via a separate transfer unit.