November 14, 2017 Minutes

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Attendees: Arlene, Eric, Heather, Jasmine, Johnson, Mike, Paul, Rinki, Ross, Shafi, Sharon Srinivas, Michael Apologies: Bharath

Introduction to Ross

  • OSI Listing (Office of Scientific Investigations)
    • Looks at auditing our clinical trial data
    • Call out of a request for subject level data listing by site
    • This looks at safety domains of data
    • Listings need to be split down so that each site can be assed for audit
    • SAS Dataset – would be separate from this, there is an additional request as a part of the deliverables which is voluntary
    • Michael – Would be very helpful from a reviewer point of view

Spotfire web browser

  • You need a consumer account which comes with purchase from a sponsor side the sponsors need to grant you access
  • Clinical trials issue is that is focuses on initial submission
  • What if we provide the FDA an embed workbook where the data is so they can have access to it and embed it into their software
  • The FDA would need a spotfire account to open the document
  • Paul- Access through commercial website is a concern
  • Eric- In addition to deploying or offering spotfire template
  • Talk with OSI to see what they are going to do with the data and what they are hoping to get out of the data
  • Mike- We would want the tool to be equal from both the sponsor to the FDA and vice versa it would have to flow both ways with the same tool.
  • Paul- Can we distribute this across different sectors so that solutions that can be done that way will be preferable in the long run
  • The data will all be taken from the XPT files

Sharon – Questions for FDA

  • What is the Framework that could be set up that is a way to move forward?
  • Talk about tractability and reproducibility in the interactive tool package
  • Michael – OSI would need to formulate a background page
  • Spotfire has a mobile version which would be very convenient for people who are working within a field and need information quickly

  • Jreview as an alternative way to provide these listings
  • Paul – not used to much by our statisticians
  • How can we start to look into small use cases
  • Mike- Rshiny would be a better fit for transferring of information
  • If the survey goes down we can still run things locally this gives us better defence on IT issues

Next Steps

  • Paul – OSI would have to see a presentation and decide whether
  • Mike- Try to look at our goals for PhUSE (Whitepaper)
  • Make sure that the points made today become a part of our proposal
  • Paul – Make things not software specific may be preferable in the long run
  • Mike- Next meeting in two weeks on the 28th Trisha Simpson Team leader for FHIR will be presenting at our next meeting