August 24, 2017 Minutes

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Meeting Schedule Should we alter schedule to alternate weeks with the regular PhUSE meeting so they don’t occur on the same week?

- Outcome: We will keep the time as TH at 9AM but change to the 1st and 3rd Thursdays of the month.

Review of Action items (see table below)

Next steps, as needed:

  • 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

  • Contact Armando to find out the status of FDA project to standardize the format (XML) and submission of patient narratives. Ingeborg

Status Complete, see DataVisSLDR_Research

  • CDISC efforts/involvements to standardize the format (XML) and submission of patient narratives.

Status Complete, see DataVisSLDR_Research

  • Recruit an official FDA liaison for our group

Michael Status In process

  • Investigate patient profile tools in use at FDA

Status Deferred until FDA liaison or contact found

  • Investigate patient profile tools in use in industry

Status Complete, see spreadsheet: PatientProfilesToolsAndUse

  • Find out what FHIR group is working on and if patient narratives are in their current scope

Status new

  • How does fda require narratives to be submitted, does a sponsor need to submit case summaries if the data is in SDTM format

Status new

  • Review/ Add details of your position and company to spreadsheet: DataVisSLDR_Research, Tab, groupMemberMakeup

Status new

  • Brainstorm about what information to collect to determine metrics for evaluating tools (ease of use factors, ability to work with different datasets, ability to customize display etc and what is important to users

Rebeka, Eric
Status new

  • Develop a survey to get more information from our group and the larger data vis group on use of patient profiles and/or look into having a group panel discussion

Status new