Project Scope 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 | |
Lukasz Kniola | |
Sarah Nevitt | |
Rashmi Dodia |
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. |
CURRENT STATUS Q42020 |
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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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