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ZENODO
Event . 2024
License: CC BY SA
Data sources: ZENODO
ZENODO
Event . 2024
License: CC BY SA
Data sources: Datacite
ZENODO
Event . 2024
License: CC BY SA
Data sources: Datacite
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How to open up clinical and research data The interplay between rules, standards and practices

Authors: Caso, Roberto;

How to open up clinical and research data The interplay between rules, standards and practices

Abstract

Clinical and research activities produce enormous amounts of data. These data represent an invaluable treasure from multiple points of views: scientific interests in creating new medicines and pursuing progress and innovation in the health domain, the necessity to verify the studies carried out, the purely commercial approach on protecting the effort to obtain a marketing authorization (i.e drug control regulation by reference agencies), and the public interest in access and disclosure. Access to this information is often severely limited (if not completely hindered) by forms of exclusive rights (Intellectual Property Rights, Sui generis protection such as the so-called data exclusivity, etc.). The regulations regarding the protection of personal data (indirectly) contribute too in making sharing processes more complex. On the contrary, Open Science, FAIR (Findability, Accessibility, Interoperability, and Reuse) principles, transparency and flexibility needs and the creation of public databases on clinical trials and health data push forward the implementation of accessible or open data. The Conference aims to investigate the interplay between the several legal tools involved in this phenomenon and open science for health and clinical trial data from multiple perspectives, focusing on EU law but with a comparative approach and methodology (i.e. USA, Canada, Israel, South-Africa) that takes into account the complex regulatory framework.

Related Organizations
Keywords

Personal data protection, Privacy, Clinical Trials Data, Intellectual Property, Data exclusivity

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average