23 JUL 2018

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Attendees: Phil, Patty, Catherine, Kevin, Bob, Kathryn, Fred, Jennifer, William, Sue, Drashtti,
Apologies: Maria, Mike, Thomas

Core Team Agenda Two NPRs: Data Visualization for Nonclinical Safety Signal Detection (Phil/Alan) & RDF/Linked Data (Drashtti/Thomas)

  • Both have been sent to the SC who provided some feedback
  • Safety detection approved on the basis on more clarification on the objectives
  • Mirrors something we’re trying to do the in Etransafe project
  • Looking to search the literature for outcomes the indicated adverse events to see if we can formalise those to some representation in pre-clinical
  • We have access to pre-clinical data because of our relationship with Etransafe
  • We hope to have a deliverable together by CSS in the form of a poster and eventually a journal article
  • Team will be presenting at next webinar in September

RDF Linked Data Project also received some feedback from the SC

  • We noticed RDF is not being discussed within Nonclinical
  • We want an open model – We should have a RDF representation of Nonclinical data
  • Identify SEND data into RDF representation
  • Comments from SC – what is required – Do we want to show we will be educating them
  • Could you come up with ideas on how it might be used in Nonclinical
  • Team will work on the NPR and resubmit to SC

US Connect 2019 (Bob Friedman) – Connect streams & call for abstracts (due Aug 31st)

The meeting has many streams that can be found here: https://www.phuse.eu/us-conference-streams-2019

  • These streams are likely ones for papers/posters about non-clinical data usage:
    • Analytics, Big Data& Statistics
    • Data Standards and Governance
    • Machine learning
    • Submissions & Agencies
    • Standards implementation
    • Trends and Technology

  • One suggestion is that presentations already developed this year for CSS that would have interest to a broad group of clinical and non-clinical attendees would be good to submit to this conference.
  • Non-clinical submitters should also inform Bob Friedman (bfriedman@xybion.com) what stream they are submitting to.

  • Bob Friedman will look into submitting an abstract about the SEND readiness survey. Kevin Snyder is looking into a data visualization presentation.
  • Sue DeHaven is considering a submission regarding CBER submission standards.
    • There will be a discussion on CSS – if anything needs to change
    • CSS is still a working meeting – we do not want to accelerate what we would produce at CSS for Connect
    • We are trying to get clinical and nonclinical to collaborate and Connect is presentation based, we can use this for networking and advertising our work
    • Bob to look through this year’s CSS to see if there is an overlap with Clinical to potentially present at Connect
    • Audience for Connect will be those who are not within a WG
    • We want to make sure our Nonclinical presentations are in-between so we’re not competing with Clinical topics

  • NCT Project Activities Roundtable
    • SDRG – Postponed meetings till August 30th where we will look to decide to update to template or guidance for 3.1 if so we would like to have that ready for CSS we need to decide on what new examples we needs
    • Define Codelist – Postponed meetings till September


  • Should you be submitting abstracts for Baltimore please send to Bob
  • Drashtti and Thomas to work on updating the NPR to resend to the SC


  • Next meeting cover the scripts new project
  • Non-clinical Define file completion guideline as a potential project for CSS 2019
    • Would be great have the metadata submission from CDISC
    • Clinical define completion guideline for clinical to be completed for the next CSS
  • Next meeting we will look at our Connect participation – Bob will update the team on submissions
  • CSS Planning – Starting in September