Abstract
Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (inability to incorporate de-identification tools in the submission workflow, lack of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system's potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data.
Highlights
The sharing of clinical trial data still occurs mainly with in a closed professional evironment through direct and personal sharing, rather than via accessible data repositories
This paper explores the suitability of a widely used data repository system, DSpace, for supporting the long-term management of individual participant data (IPD) generated from clinical research while conforming to defined quality criteria
The aim of this paper is to describe the development of a demonstrator repository based on the DSpace system and assess it using a pre-defined set of quality criteria and requirements
Summary
The sharing of clinical trial data still occurs mainly with in a closed professional evironment through direct and personal sharing, rather than via accessible data repositories. There are many different types of repositories, such as generic repositories for all kinds of life-science data, repositories exclusively for clinical research data and specialised repositories with a specific focus, e.g. a single disease area, and major heterogeneity exists with respect to data-upload, data-handling, and data-access processes. This heterogeneity of repository types and features, reflects both the different purposes and perspectives of repository founders, and the relative immaturity of repository data-sharing services. In a productive repository, appropriate policies and procedures would be needed to direct the use of the version 2 (revision)
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