Confirmed Projects


 

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The Computational Science (CS) Working Groups and associated Working Group Projects are the cornerstone of the CSS and will be carried over to the European meeting. Visit the CS Working Groups web page for further details.

Project

Project Leads

Overview

Data Transparency Jean-Marc Ferran The Data Transparency Working Group formed in 2014 and includes members from CRO's, Academia, Pharmaceuticals, Software, Service and Academic organisations. The Working Group released the SDTM De-Identification Standard in May 2015. This standard has been implemented in numerous organisations and referenced in a variety of Industry and Regulatory guidances (TransCelerate, EMA, Ontario Data Protection Agency, etc). The Working Group is currently finalising a de-identification standard for SDTM and a publication on Policy 0070 interpretations. The session in London will be the opportunity for the Working Group and other new participants with experience in data de-identification to discuss the latest burning topics related to these deliverables before their publication.
Nonclinical Topics Jaga Virayah & Philip Drew At the PhUSE CSS in London this year, the Nonclinical Working Group is looking to explore several topics supporting Industry not only in the implementation of SEND but in the meaningful use of the SEND data as well. We are targeting topics like SEND visualisation, SEND Regulatory review and usability feedback, and wrapping up by working to understand the topics that would be of most interest to the European community going forward. Attendees will gain a good understanding of the latest changes to SEND, the known issues that impact regulatory review and what the standards communities (PhUSE and CDISC) are planning to address in the near horizon. In particular, there will be a review of the 'Fit for Use' pilot that was the first of it's kind to surface specific information on data fitness for use in regulatory science reviews. This pilot was a collaboration between PhUSE Nonclinical, CDISC SEND team, and the FDA.
Optimizing the Use of Data Standards Scott Bahlavooni & Chris Price The 2016 EU CSS marked the first meeting of the Optimizing the Use of Data Standards Working Group SDTM/ADaM Implementation FAQ project. The project returns for 2017. The sessions will include a project overview and update, review of upcoming CDISC releases, and continue work to resolve questions from the CDISC Implementation Community.

 

 

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