7 Selection and preservation

The long-term preservation of research data and biological samples is important to make sure we have reproducibility and compliance with ethical and legal requirements. This section outlines the strategy for selecting which data and samples will be retained, how it will be stored and for how long, as well as the mechanisms for ensuring secure storage and accessibility. All processes adhere to the FAIR principles and comply with GDPR to protect participant privacy and data integrity.

7.1 Retention and storage

As a general rule, all data generated by or from participants will be retained and stored on GenomeDK’s secure servers. Exceptions may include more technical/system data such as log files, which have limited long-term value.

Study data: All core datasets will be preserved for a minimum of 15 years after study completion. The long-term plan is to integrate these datasets into a joint Steno Database, currently under development, to ensure continuity beyond the funding period.
Biobank samples: We will initially retain biological samples until the end of the current funding period. Plans are in place to establish a Steno Biobank before this point, where we will transfer ON LiMiT samples for extended preservation.

7.2 Study timeline

Data collection for the feasibility study will span approximately 13 months (12 months per participant), while the main study will involve a two-year participation window per participant, with the last participant’s final visit expected in 2032. Retention commitments extend well beyond this timeline to support future research.

7.3 Access and future use

To maximise reuse, we will develop a searchable website to enable discovery of available variables and datasets, as described in the Documentation and metadata section. Initially, access is expected to be of particular interest to the study team. In accordance with the Publications Guidance, data will be made available to a wider research community once primary findings have been published, subject to an application and approval process.

7.4 Long-term strategy

Wherever possible, data that cannot be re-measured will be preserved beyond the funding period, either on GenomeDK servers or within the planned Steno Diabetes Centre database. This ensures that valuable datasets remain accessible for secondary analyses and future research, supporting sustainability and compliance with FAIR and GDPR principles.