8 Data Sharing
Sharing data from research projects is essential for promoting transparency, reproducibility, and collaboration within the scientific community. By making data findable, accessible, interoperable, and reusable (FAIR), we enable other researchers to build upon existing work, validate and verify findings, and generate new insights. This section outlines how data and metadata from the project will be shared, under what conditions, and with what safeguards in place.
8.2 When will the metadata be available?
We aim to start metadata publication as soon as data collection starts. A preliminary release will be based on the feasibility study, which we plan to use as a test case for the metadata infrastructure. While we primarily intend to use this dataset to identify any issues with the two most demanding arms of the study, it will also be used as a testing ground for the metadata sharing process. We do not expect high external demand for the feasibility data, but it will help ensure readiness for the main study.
8.3 Who is the audience for the data?
We anticipate that most data access requests will come from researchers affiliated with the study or collaborating institutions. However, external researchers may also apply, provided they meet the criteria outlined in the data access guideline. The audience may include clinical researchers, epidemiologists, or data scientists researching diabetes-related topics, as well as anthropologist or other social scientists looking at behaviour in relation to food and exercise for people with type 2 diabetes.
8.4 How will researchers get access to the data?
Researchers must submit a formal application detailing their planned use of the data, including which specific data points they require and why. Applications involving sensitive data categories must include a clear justification for their necessity (for instance in cases where the data is to be uploaded to Denmark Statistics). We will develop a guide on the application process, including eligibility criteria and review procedures and that we will make available as a website.
8.5 How will the data be made available?
Once the steering committee has approved an application, we’ll make the requested data available in a dedicated project folder on GenomeDK (GDK). Raw data must remain on the GDK server, and only analysis scripts and results may be exported. Researchers will need to create an account with GDK to access the folder and work on their analysis environment. In some cases, it may be possible to upload a dataset to Statistics Denmark, under the SCDA Statistics Denmark project database. We only consider this option for projects requiring linkage with other national datasets.
8.6 How will access be controlled?
There are three main ways to access data, and only one is used for data analysis. Data will be available to a few members of the study team on REDCap where we do data collection. All data collected by the LIVA app will be available to clinicians involved with the running of the study in the LIVA system. Finally, the research data we have collected, cleaned, and stored on GDK servers is also where the analyses will take place. Access to the finalised research data will be controlled by the central study team on GDK, with each successful data application getting their own project folder with only the data requested. All the programming scripts used to create these data sets will be stored in the main study folder on GDK to ensure transparency and reproducibility. We expect that those who have access to the data collected within REDCap will not use the data for analysis and/or publication. The data collected by LIVA will be available through the use of the Clinician Portal and LIVA Reporting Module, which is encouraged for monitoring participant progress but should not be used for publication purposes.
8.7 What kind of IP or license will be used?
A formal decision regarding intellectual property rights and licensing for shared data is still pending. This will be finalized before the main study data is made available to external researchers.
8.8 Additional considerations
We may need to share some data from the feasibility study and analyse it before the launch of the main study, but the formal end points in the study registration on ClinicalTrials.com should help clarify what data points will be needed for this. This process should be planned and initiated as soon as possible. A data sharing agreement is already in place between the five participating centres, outlining responsibilities and procedures for internal data access and collaboration.