Use of Open Data repository for sensitive data from clinical trials

What is it about?

During medical research a lot of data is generated that is never contributed to secondary use and shared with other researchers. Indeed, incontrast to Open Data, medical research data is only rarely shared and when then only under very strict usage conditions. The area of clinical and medical research is part of the regulated domain in which many rules and restrictions prevail, not only the ones for privacy protection, but also the ones covering data ownership and licensing. In this context, we installed the repository DSpace and evaluated it specifically for clinical trials data; we examined its suitability for providing access to participant data from clinical research in a legally compliant way. We uploaded publicly available clinical trials data and used a set of quality criteria and requirements that had been previously created by a group of stakeholders of the clinical research area. The result of our evaluation was that our DSpace installation was able to support most of the requirements for regulatory compliant clinical trials data access. Some aspects though were lacking. We found that DSpace clearly has considerable potential in for dealing with sensitive data, though it was constructed for Open Data management. DSpace was chosen, because it is a fit for work solution, it can be installed even in a short time and with limited resources, it is a free repository and requires after installation only little efforts in maintenance. Especially strong is DSpace‘s abilities in metadata management and identifier provision. DSpace offers several data quality tools, like a reviewer workflow, and sustainability due to support by the Duraspace community. What is lacking is a tool to monitor and track uploads, an user authentication system and a system to check deidentification of data. Missing is the integration of signed data transfer agreements, contracts that are very important for clinical trials data. Conclusion: our evaluation showed that our DSpace installation was able to support most of the requirements for regulation compliant clinical trials data access. Aspects that were lacking were identified. Here collaboration between potential user could support the development of additional tools to increase the usability of DSpace for sensitive data storage.

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Photo by National Cancer Institute on Unsplash

Photo by National Cancer Institute on Unsplash

Why is it important?

The reader is shown, how an Open Data repository can be adapted with minimal efforts and available resources to be able to meet most of the requirements for dealing with clinical trials data. During a DSpace German User Group meeting, several users reported that especially in Austia and Swiss already medical data is stored in DSpace. This showed that there is a demand for adapting Open Data repositories for restricted access. Though DSpace has been created for Open Access and FAIR data treatment, it contains already a number of features that allows for more control over the data sharing process. We showed that it may be easier to use DSpace, then to create a new repsoitoy from scratch for clinical trials data. A precondition for this is improvement in the user authentication system, help with the de-identification and anonymisation of data and a dedicated workflow for data transfer agreements, including digital signatures.

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