August 10, 2017 Minutes

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Agenda for Use of Data Visualization for Subject Level Data Review (SLDR)

Date 08/10/2017

Attendees: Rebeka, Eric, Suzy, Michael, Ingeborg

Meeting Schedule Planning a regular meeting We will meet at 9AM on the 2nd and 4th Thursdays of the month Review of Wiki (not done) Current abstract and previous versions available at https://phuse.teamworkpm.net/#files/2189310. Meeting minutes from the previous meeting are here: https://phuse.teamworkpm.net/#/notebooks/98344. I will ask Wendy to upload these minutes in the same place Existing Efforts by Sub Group 2 Original scope for this project was Patient Narratives and Patient Profiles Go from aggregate to detailed level to get patients of interest based on some graphic visualization and patient points Review of current abstract (https://phuse.teamworkpm.net/#files/2189310) Deliverable for phuse: white paper Refinement of project and Next steps (see action items below) Agree on deliverable and Subject Outline agreed upon, may make changes as we go 'Fit for Use' New Project request (Starting point- current abstract overs this) Communication plan, timeline, deliverable goals Goals it to have a white paper delivered by the March 2018 Phuse Meeting Action Items from Meeting

Action

  • Contact Armando to find out the status of FDA project to standardize the format (XML) and submission of patient narratives. Ingeborg
  • CDISC efforts/involvements to standardize the format (XML) and submission of patient narratives. Michael
  • Recruit an official FDA liaison for our group Michael
  • Investigate patient profile tools in use at FDA Suzy
    Status Deferred until FDA liaison or contact found
  • Investigate patient profile tools in use in industry Status I don’t remember assigning this