About the project
NUKLEUS (NUM Clinical Epidemiology and Study Platform) is a central Reseach Infrastructure in the Network of University Medicine (NUM). It supports researchers from the planning and implementation to the evaluation of clinical and clinical-epidemiological studies.
NUKLEUS covers the entire process chain of study support:
- Support with study design and cost planning
- Integration and coordination of study centres
- Implementation of the ethical and legal framework
- Study initiation and quality assurance
- Data and biosample management
- Fair utilisation of the data and biosamples obtained
- Data analysis and data re-utilisation
NUKLEUS works closely with the Methods and Biospecimen Hub at NUM (NUM-MB).
Since July 2025, NUKLEUS has been expanded as part of NUM 3.0 to include two important new areas of responsibility: data acceptance and processing of external healthcare-related data (DAAeD). This includes health insurance, reporting and cancer registry data. In addition, NUKLEUS now offers support for adaptive clinical platform studies, which enable flexible and efficient study designs for modern, patient-centred research.
The most important things at a glance
The vision of NUKLEUS is to establish a ready-to-use, scalable and powerful infrastructure and, in cooperation with experts from university medicine in Germany, to realise high-quality studies on innovative and currently relevant medical issues within a few weeks and provide researchers with answers with a high level of significance.
With the interdisciplinary expertise of NUKLEUS, researchers can concentrate fully on their scientific questions. This leads to greater efficiency, greater accuracy and a broader spectrum of research results. NUKLEUS builds on the successes of the Network of University Medicine and strengthens the efforts that have been developed as part of pandemic management and national pandemic preparedness in order to be ready for future pandemic situations. The aim is to be able to start and conduct nationwide studies in future without losing time - for research that provides answers more quickly.
The processes of the infrastructure are continuously developed further. The technical requirements for smooth cooperation between the infrastructures and sub-projects of the Network of University Medicine are constantly being expanded and optimised - for example for the joint (re-)use, processing, storage and release of documents, data and biosamples.
On the other hand, interfaces between the infrastructures, sub-projects and sites are being identified and joint processes harmonised.
The NUKLEUS team develops and operates the Reseach Infrastructure at NUM for the efficient joint planning, implementation and evaluation of clinical and clinical-epidemiological studies in order to make high-quality data, biosamples and analysis results widely available to the scientific community. This is realised in particular in cooperation with the NUM Study Network (NUM SN) and the Methods and Biospecimen Hub at NUM (NUM-MB). Depending on the study design of the clinical and clinical-epidemiological studies supervised by NUKLEUS, data and biosamples can already be made available to researchers for subsequent use during the recruitment phase. The Use & Access procedure established in the NUM guarantees the rapid and structured provision of data and biosamples in accordance with the FAIR principles.
NUKLEUS creates a space for trusting cooperation between all NUM stakeholders, provides broad interdisciplinary expertise in the implementation of clinical-epidemiological studies and includes ready-to-use solutions in terms of scientific methodology, organisation and technologies that can be provided quickly and in high quality. As a supra-regional and cross-sectoral infrastructure, NUKLEUS cooperates with existing NUM infrastructures and sub-projects as well as NUM-associated initiatives and partners and is internationally compatible.