Assessment of a demonstrator repository for individual clinical trial data built upon DSpace.

F1000Research
Birol TilkiChristian Ohmann

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 (the ability to include de-identification tools and the availabiltiy of a self-attestation system) and three requirements wer...Continue Reading

References

Jun 27, 2015·Bioinformatics·Paul R BurtonBartha M Knoppers
Mar 16, 2016·Scientific Data·Mark D WilkinsonBarend Mons
May 16, 2020·Scientific Data·Dawei LinJohn Westbrook

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Software Mentioned

Apache Tomcat
Archivematica
Tomcat
DSpace
Dryad
Java
Invenio
CNRI Handle System
ECRIN
PostgreSQL

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