August 24, 2017 Minutes
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 Wiki/Confirm that people are able to find the minutes and other docs
- 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
Review of Action items (see table below)
Next steps, as needed:
- 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
- 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.
Status Complete, see DataVisSLDR_Research
- Recruit an official FDA liaison for our group
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
- How does fda require narratives to be submitted, does a sponsor need to submit case summaries if the data is in SDTM format
- Review/ Add details of your position and company to spreadsheet: DataVisSLDR_Research, Tab, groupMemberMakeup
- 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
- 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