Policy 0070 Interpretations

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Project Overview

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:

  • Policy 0070 Submission Reviews
  • Handling of Narratives
  • Data Utility
  • Risk Assessment in CSR

Project Leads & Members

Name Role Organization
Jean-Marc Ferran Project Lead PhUSE
Lukasz Kniola Co-lead Biogen
Sarah Nevitt Co-lead University of Liverpool
Rashmi Dodia Co-lead MMS Holdings

Project Updates

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.

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.

Objectives and Timelines

Objective Timeline

Project Activities

  • US CSS 2016 - Initial Workshop to define the different subtopics of the "Policy 0070 Interpretations" project
  • EU CSS 2016 - Follow-up from US CSS 2016 and planning of tasks
  • EU CSS 2017 - Review of initial deliverables and discussion with EMA Policy 0070 officers after 1 year of Policy 0070 submissions.
  • EU CSS 2018 - Review of Data Utility and Handling of Narratives drafts and discussion with FDA officers around their Data Sharing initiative

Deliverables