EOSC-Life Project plan for optional services and future cooperation with IDDO
Creators: name: Panagiotopoulou, Maria
name: Rujano, Maria
name: Felder, Gerd
name: Contrino, Sergio
name: Ohmann, Christian
name: Kichenassamy, Swarnalathaa
name: Gorianin, Sergei
name: Demotes, Jacques
name: Kouylekov, Milen
name: Thomassen, Gard
name: Guerin, Philippe
name: Brack, Mathew
Publisher: name: Zenodo
Year: 2023
Subjects: Life science research infrastructures
Clinical Research Repository
Data use, data transfer
COVID-19 clinical studies

description: In the context of EOSC-Life WP14, the collaboration between the European Clinical Research Infrastructure Network (ECRIN) and the University of Oslo (UiO) aims to jointly create, develop, implement, and maintain a Clinical Research Repository. This repository will host individual participant data (IPD) from COVID-19 clinical studies, adhering strictly to European regulations, especially the General Data Protection Regulation (GDPR). The repository's functionality is divided between two primary systems: the Services for Sensitive Data (TSD) infrastructure managed by UiO and a Repository Management System (RMS) developed by ECRIN. The RMS is purpose-built to facilitate and document the various workflows involved in managing the repository, including interactions with data object providers, requesters and users. The TSD system is responsible for securely storing, providing access to, and enabling the controlled reuse of data objects, such as datasets with restricted access. The first chapter of this report provides a high-level description of the Clinical Research Repository workflows and operations with a focus given on the Data Transfer Process and the Data Use Process. The second chapter describes the need for developing optional services to support the operations of the Clinical Research Repository. Gaps and needs in the current European clinical research data sharing landscape have been identified through a desktop search, discussion with stakeholders and a small-scale survey completed by people working in clinical trials and cohort studies. The authors of this report conclude that i) a de-identification support service, and ii) a data standards support service, would greatly assist data providers in making their clinical research data available for re-use, especially given that such expertise is often lacking in-house in academic settings. The third chapter explores additional features that can be integrated to extend the core functionality of the Clinical Research Repository. A non-exhaustive list includes a file fingerprinting feature, a digital watermarking feature for (image) files, a summary statistics feature for dataset files and the provision of DICOM (Digital Imaging and Communications in Medicine) reader and PACS (Picture Archiving and Communication Systems) within the secure TSD workspace. The fourth chapter provides an assessment of the Infectious Diseases Data Observatory (IDDO), a data sharing platform established for malaria in 2009 and expanded on other infectious diseases since 2016 at the University of Oxford in the UK. More precisely, the EOSC-Life WP14 partners looked into the research themes covered by IDDO, the data transfer and data re-use processes, COVID-19-related work, collaboration with other repositories (e.g., Vivli) and FAIR registries (e.g., FAIRsharing). The aim of this assessment is to identify mutual points of interest and establish possible lines of future collaboration between IDDO and the Clinical Research Repository, for example as part of a common project proposal. An overarching conclusion is that for these optional services, additional features, and plans for cooperation with IDDO to materialise, extensive discussion among the involved parties, funders and policy makers will be needed. The sustainability of the Clinical Research Repository for the next ~4 years has been secured via project funding, thus giving an opportunity for such dialogue to continue and project plans to evolve as needed.