Scope |
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The PHUSE Data Transparency |
Working Group has been reviewing very closely Policy 0070 and |
its External Guidance. The |
Working Group is looking further into different aspects of the policy and |
aim at providing further guidance and interpretations where needed |
. The Working Group has been working on 4 topics:
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Project Leads | |
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Jean-Marc Ferran | jmf@qualiance.dk |
Lukasz Kniola | lukasz.kniola@biogen.com |
Sarah Nevitt | sarah.nevitt@liverpool.ac.uk |
Rashmi Dodia | rdodia@mmsholdings.com |
Resources | |
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A review of the first 47 EMA policy 0070 submissions was conducted and presented during the 2017 EMA TAG meeting. | |
The White Paper on "Handling of Narratives" has been completed and published on the PhUSE Website. | |
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We are looking for volunteers to work on defining a Data Utility scale to be used by sponsors to evaluate and report the Data Utility in their Policy 0070 anonymisation report. We are also looking for a project lead to work on a White Paper around measuring re-identification risk in CSRs. |
Recent Activities |
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