eLEVATE

eLEVATE is the first research project to build on the infrastructure of the National Autopsy Network (NATON). It expands the range of data recorded in NAREG (National Autopsy Registry, a data platform within NATON) to include five further research areas, thereby enabling the systematic study of almost all diseases observed in the context of post-mortem examinations.

For each focus area, a specific module is designed and implemented in NAREG to retrieve, alongside the core data, case-specific information on the respective post-mortem cases and compile this in the register. The deaths relevant to the individual use cases are identified by the participating post-mortem centres and, provided the relevant criteria are met, recorded in the register by entering the post-mortem data record. The fundamental principles of NAREG stipulate that the associated biological samples remain in the possession of the respective centres. In the long term, the aim is to achieve cross-centre harmonisation of post-mortem standards, as well as the development and formulation of SOPs and guidelines.

eLEVATE thus addresses challenges in post-mortem-based research, such as a lack of standardisation and the demands of complex studies: Through the nationwide, multicentre collection of data and biological samples, the limitations of individual centres – such as low case numbers or a restricted methodological range – can be overcome. Researchers gain access to standardised, high-quality post-mortem data, which significantly facilitates studies into disease mechanisms. At the same time, local hospitals benefit from feedback on the findings – for example, as part of interdisciplinary case conferences – which contributes to quality assurance and to the improvement of training and continuing professional development.

The implementation of eLEVATE requires cross-site coordination and the harmonisation of processes within a network. A key challenge lies in mapping the five different research priorities, each with their own specific requirements, within a common registry structure, whilst ensuring consistent data collection. To achieve this, suitable data and inclusion criteria must be defined, existing documentation processes at the participating sites must be taken into account, and common standards must be developed.

Furthermore, challenges arise from the integration of the new modules into NAREG, as well as from the identification and recording of suitable post-mortem cases at the individual sites. Different local conditions, resources and procedures must be taken into account. Close and ongoing coordination between the participating sites, individuals and specialist disciplines is necessary to address these challenges.

eLEVATE builds on the infrastructure provided by NATON and NAREG. Implementation is taking place in a phased and continuous manner:

• Development and implementation of five new modules in the post-mortem register to record case-specific information relating to the respective post-mortem cases
• Submission of the necessary amendments to ethics committee approvals
• Drafting of centre agreements, obtaining approvals from the relevant data protection officers, and granting access to NAREG for all participating centres
• Entry of relevant deaths into the respective modules by the affiliated post-mortem centres (associated biological samples remain in the possession of the respective centres)
• Payment of flat-rate data reporting fees for each eligible and complete entry
• Harmonisation of post-mortem standards and development of nationwide SOPs / guidelines
• Conducting initial pilot and validation studies

The processes are managed by a centralised project management team, supported by administrative staff responsible for reporting, quality control, case review, documentation and coordination.