NUKLEUS

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 NUKLEUS research data infrastructure is made up of several individual work packages that together support researchers in the planning, implementation and evaluation of clinical and clinical-epidemiological studies:

Laboratory Sample Information Management System

The Laboratory Sample Information Management System (LIMS) advises and supports the development and implementation of biosample-related study processes from sample collection to analysis. This also includes storage and dispatch processes as well as the transfer of analysis results.

Clinical Data Management

The aim of Clinical Data Management (CDM) is to harmonise data and to create and integrate validated clinical study databases as long-term data collections. CDM provides the data infrastructure and offers support and administration of the study databases.

Transfer Centre

The Transfer Office is responsible for the compilation, preparation and coordination of the publication of harmonised clinical data, biospecimen data and image metadata in accordance with the approval of the Use & Access Committee, taking into account the data protection concept.

Fiduciary body

The Independent Trusted Third Party (THS) manages identity data, pseudonyms and consents centrally for all study participants. It thus contributes to safeguarding the rights and wishes of the participants and forms the interface to researchers and project partners.

Effort and performance recording unit (RPA)

The RPA is responsible for calculating the costs of expense allowances and infrastructure services for new prospective studies and supports these projects in defining test criteria for measuring expenses and quality and performance indicators. It coordinates the implementation and dashboarding of these measurements so that the centres can monitor their study performance in a timely manner.

Data acceptance and processing centre for external data

The Data Acceptance and Processing Centre for NUM External Data (DAAeD) will be the central office within NUM for the acceptance, integration and processing of nationwide data from health insurance companies and cancer/reporting registers and, in future, other registers. This will expand the database within the NUM to include a wide range of data and significantly increase the spectrum of research questions that can be answered.

Adaptive platform trial support unit

The Adaptive Platform Trial Support Unit (APT-SU) offers theoretical and practical expertise in the planning and implementation of adaptive platform trials (APTs), which has been established within the Network University Medicine. It serves as a central point of contact for researchers and partners to increase the competitiveness of German university medicine in the field of clinical trials and to ensure pandemic preparedness.

Dynamic Use & Access Coordination Unit (DUA; Dynamic Use & Access Coordination Unit)

The NUKLEUS DUA is responsible for coordinating the subsequent use of data, biosamples and image data within the NUM. It takes on the communication and organisation/coordination tasks in the dynamic Use & Access procedure and supports the process from application to data output.

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.