Keele Data Repository

Smith, Jo, Johnson, Zoe and Heap, Jodie (2026) Operationalising Responsible Data Sharing and Reuse in a Clinical Trials Unit - Poster.

Within many Clinical Trials Units (CTUs), data access and data sharing processes have evolved through layered documentation, disparate storage locations and manual workflows, creating burden for both requesters and reviewers. Furthermore, these processes don’t conform to FAIR and CARE principles. Keele Clinical Trials Unit are enhancing the current process to streamline and simplify the process and embrace FAIR and CARE principles. This work has the potential to improve the efficiency, transparency and consistency of research data access within Keele Clinical Trials Unit. By simplifying workflows and reducing reliance on disparate documentation and manual processes, the revised approach should reduce administrative burden for both researchers' requesting data and those reviewing and approving access. Alignment with FAIR and CARE principles, alongside clearly defined data packs, will support more responsible, transparent and reusable data sharing. This will help maximise the value of research data already collected, facilitate secondary research and collaboration, and reduce unnecessary duplication of research activity. The approach may also provide a transferable model for other Clinical Trials Units and research environments facing similar data access and governance challenges.