9 Responsibilities and resources
Effective data management relies to a great extent on clear guidelines as well as clear definitions of roles and responsibilities. By defining responsibilities and ensuring the right expertise and tools are in place, then data quality, compliance, and the long-term value of the project’s outputs should be ensured. This section outlines the key roles, and resources dedicated to managing data within the study.
9.1 Responsibilities
This section outlines who is responsible for key aspects of data handling (from collection and documentation to long-term storage and sharing) and how collaboration between people and institutions supports the integrity and usability of the data throughout the study. For now we’ll be looking at the first 6 years of the study (the active phase), but data will be stored for at least 9 years more (minimum of 15 years in total), and this will need to be addressed further down the line.
9.1.1 Data management roles
The project has appointed a dedicated Data Architect at Steno Diabetes Center Aarhus (SDCA) who holds primary responsibility for the overall data management strategy. This includes overseeing data capture, metadata production, data quality assurance, secure storage, backup and recovery procedures, long-term archiving, and data sharing. The data architect will make sure that data flows are secure and well-documented.
9.1.2 REDCap setup and study team contributions
While the data architect is ultimately responsible for the setup and configuration of REDCap, much of the practical implementation will be carried out by some members of the study team at Steno Diabetes Center. These team members will also contribute to identifying and describing specific data points registered in REDCap.
9.1.3 Metadata and Documentation
Metadata will be organised using Seedcase Sprout, based on the data recorded in REDCap (for data registered there) and a data dictionary which will be developed in collaboration with the LIVA team as the study progresses.
This will result in metadata that is consistent, comprehensive, and aligned with FAIR principles.
9.1.4 Long-term data handling and storage
The data architect is also responsible for overseeing the work carried out by the Seedcase team in converting raw data into Parquet files for long-term storage. It is essential that this process preserves the integrity of the original data, and the data architect will ensure that no information is lost or altered during the conversion.
9.1.5 Sub-study data integration
Any sub-study that generates data is expected to submit its dataset in full to the main project, accompanied by appropriate metadata. Although the SDCA team is not responsible for collecting this data, the data architect and the Publications Panel share responsibility for ensuring that sub-study teams understand their obligations. This includes verifying that all relevant data is submitted to the main study and properly integrated into the central repository on GenomeDK.
9.1.6 Compliance
The data architect and project manager will jointly ensure that the data management practices outlined in this plan are adhered to throughout the project lifecycle. Regular reviews will be conducted, and updates to the DMP will be made as needed.
9.1.7 Contingency planning
The study as a whole will run over 6 years, so it is unlikely that all original staff will still be present at the end of the study period. At present there is no formal guidance on how we expect to cover either long-term absence or people leaving the study, but it is expected that the core study team, data architect and project manager alongside the Project Secretary and the Chief Investigator will be able to cover most of the urgent tasks if needed.
A core principle of the project is documentation and this is ensured by using GitHub and sharepoint across study sites. A minimum of documentation from each team member, depending on role, is required in case of people leaving.
Funding has been obtained from the Novo Nordisk Foundation to conduct the study. Funding for training and upskilling any replacement staff is part of this funding. However, as the project is ongoing, further funding will also be sought to accompany future needs. This is the responsibility of the Project Management Panel to ensure.