EOSC-Life Report about use and user satisfaction of the COVID-19 repository, including a maintenance and sustainability plan
Creators: name: Contrino, Sergio
name: Felder, Gerd
name: Ohmann, Christian
name: Panagiotopoulou, Maria
name: Kichenassamy, Swarnalathaa
name: Gorianin, Sergei
name: Demotes, Jacques
name: Kouylekov, Milen
name: Thomassen, Gard
Publisher: name: Zenodo
Year: 2023
Subjects: Life science research infrastructures
Clinical Research Repository
Individual Participant Data (IPD)
COVID-19 clinical studies

description: In EOSC-Life WP14, the European Clinical Research Infrastructure Network (ECRIN) has partnered with the University of Oslo (UiO) in order to commonly design, develop, implement and operate a Clinical Research Repository for individual participant data (IPD) from COVID-19 clinical studies that is compliant with European regulations and in particular with the GDPR. The functionality of the repository is split between two main systems – the service for sensitive data (TSD) infrastructure managed by the UiO on the one hand and a Repository Management System (RMS) developed by ECRIN, on the other. The TSD is used for the secure storage, access and reuse of controlled-access data objects (e.g. datasets). The RMS is designed to support and record the workflows associated with managing the repository and its interactions with data object providers, users, and requesters. The first chapter of this report provides an introduction to the Clinical Research Repository, the actors involved, and the two main processes that it supports: the Data Transfer Process (when clinical study material is provided to the repository) and the Data Use Process (when clinical study material is accessed for secondary use). Terms around the operations of the repository such as <em>“data object”</em>, <em>“provider” </em>and <em>“secondary user” </em>are defined to facilitate the further reading of the report. The second chapter describes the steps followed for evaluating the usability and user satisfaction of the Clinical Research Repository. Usability is defined as <em>“the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use”</em>. User satisfaction is part of the usability of a system and can be defined as <em>“a measure of how well a product or system meets the needs and expectations of its users, as well as how positively users feel about their overall experience with the product or system”</em>. To evaluate the usability and user satisfaction of the repository, two workshops were organised on the 14th and 15th of March 2023 with a small group of potential users (n=13). As part of the workshops, the participants tested the alpha version of the repository and completed a usability and user satisfaction survey. Overall, the respondents of the survey appreciated the Clinical Research Repository as a tool to facilitate clinical research data sharing and reuse. Usability scores according to the UMUX-LITE and SUS standards are provided. The respondents also raised points for improvement that are being addressed for the beta version of the tool in order to increase its usability and user satisfaction. The third chapter details the requirements for the maintenance and sustainability of the Clinical Research Repository, taking into account the needs of both the RMS and the TSD. The cost estimations include needs in software, hardware, and personnel (e.g. for the repository manager, for developers, for legal support with contracts). In an effort to be precise, estimations are provided for a short-term, a mid-term and a longer-term period. Possible funding models for the repository are discussed. Beyond the EOSC-Life project, the repository’s short-term sustainability has been secured via follow-up grants; however, for the longer-term sustainability plan to be translated into a concrete reality, extensive discussions will be needed with relevant stakeholders following the public launch of the repository.