Dataset Information

OpenPVSignal: Advancing Information Search, Sharing and Reuse on Pharmacovigilance Signals via FAIR Principles and Semantic Web Technologies.

ABSTRACT: Signal detection and management is a key activity in pharmacovigilance (PV). When a new PV signal is identified, the respective information is publicly communicated in the form of periodic newsletters or reports by organizations that monitor and investigate PV-related information (such as the World Health Organization and national PV centers). However, this type of communication does not allow for systematic access, discovery and explicit data interlinking and, therefore, does not facilitate automated data sharing and reuse. In this paper, we present OpenPVSignal, a novel ontology aiming to support the semantic enrichment and rigorous communication of PV signal information in a systematic way, focusing on two key aspects: (a) publishing signal information according to the FAIR (Findable, Accessible, Interoperable, and Re-usable) data principles, and (b) exploiting automatic reasoning capabilities upon the interlinked PV signal report data. OpenPVSignal is developed as a reusable, extendable and machine-understandable model based on Semantic Web standards/recommendations. In particular, it can be used to model PV signal report data focusing on: (a) heterogeneous data interlinking, (b) semantic and syntactic interoperability, (c) provenance tracking and (d) knowledge expressiveness. OpenPVSignal is built upon widely-accepted semantic models, namely, the provenance ontology (PROV-O), the Micropublications semantic model, the Web Annotation Data Model (WADM), the Ontology of Adverse Events (OAE) and the Time ontology. To this end, we describe the design of OpenPVSignal and demonstrate its applicability as well as the reasoning capabilities enabled by its use. We also provide an evaluation of the model against the FAIR data principles. The applicability of OpenPVSignal is demonstrated by using PV signal information published in: (a) the World Health Organization's Pharmaceuticals Newsletter, (b) the Netherlands Pharmacovigilance Centre Lareb Web site and (c) the U.S. Food and Drug Administration (FDA) Drug Safety Communications, also available on the FDA Web site.

SUBMITTER: Natsiavas P

PROVIDER: S-EPMC6028717 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

<i>OpenPVSignal</i>: Advancing Information Search, Sharing and Reuse on Pharmacovigilance Signals via FAIR Principles and Semantic Web Technologies.

Natsiavas Pantelis P Boyce Richard D RD Jaulent Marie-Christine MC Koutkias Vassilis V

Frontiers in pharmacology 20180626

Signal detection and management is a key activity in pharmacovigilance (PV). When a new PV signal is identified, the respective information is publicly communicated in the form of periodic newsletters or reports by organizations that monitor and investigate PV-related information (such as the World Health Organization and national PV centers). However, this type of communication does not allow for systematic access, discovery and explicit data interlinking and, therefore, does not facilitate aut ...[more]

PMID: 29997499

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Project description:Open research data practices are a relatively new, thus still evolving part of scientific work, and their usage varies strongly within different scientific domains. In the literature, the investigation of open research data practices covers the whole range of big empirical studies covering multiple scientific domains to smaller, in depth studies analysing a single field of research. Despite the richness of literature on this topic, there is still a lack of knowledge on the (open) research data awareness and practices in materials science and engineering. While most current studies focus only on some aspects of open research data practices, we aim for a comprehensive understanding of all practices with respect to the considered scientific domain. Hence this study aims at 1) drawing the whole picture of search, reuse and sharing of research data 2) while focusing on materials science and engineering. The chosen approach allows to explore the connections between different aspects of open research data practices, e.g. between data sharing and data search. In depth interviews with 13 researchers in this field were conducted, transcribed verbatim, coded and analysed using content analysis. The main findings characterised research data in materials science and engineering as extremely diverse, often generated for a very specific research focus and needing a precise description of the data and the complete generation process for possible reuse. Results on research data search and reuse showed that the interviewees intended to reuse data but were mostly unfamiliar with (yet interested in) modern methods as dataset search engines, data journals or searching public repositories. Current research data sharing is not open, but bilaterally and usually encouraged by supervisors or employers. Project funding does affect data sharing in two ways: some researchers argue to share their data openly due to their funding agency's policy, while others face legal restrictions for sharing as their projects are partly funded by industry. The time needed for a precise description of the data and their generation process is named as biggest obstacle for data sharing. From these findings, a precise set of actions is derived suitable to support Open Data, involving training for researchers and introducing rewards for data sharing on the level of universities and funding bodies.

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Dataset Information

OpenPVSignal: Advancing Information Search, Sharing and Reuse on Pharmacovigilance Signals via FAIR Principles and Semantic Web Technologies.

Publications

<i>OpenPVSignal</i>: Advancing Information Search, Sharing and Reuse on Pharmacovigilance Signals via FAIR Principles and Semantic Web Technologies.

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