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Attendees: Eric, Paul, Ross, Zak, Sharon, Srinivas, Kassa, Hari, Josiline, Elena, Michael, Bharath,



  • Introduction:
    • Kassa Ayelew from FDA OSI,
    • Use this as a platform where we can share information
  • Ross Farrugia from Roche
    • Statistical Programming team
  • Presentation: Leverage interactive approach for FDA OSI listing request (Ross Farrugia from Roche)
    • Use of Data Visualisation
    • Look at an Interactive Visualisation
    • Mock up using Spotfire, you could also use RShiny (open source software)
    • Kassa - The intention of the request is to make it easier to do an inspection as well as to provide information (Could be either hard or soft copies) we are depending on more electronic format. We want to put this into a format that is easy for investigators.
  • Zack - Any objections to interactive format (filter and sort domains linked by subject numbers)
    • Kassa - No problem with the interactive format it would be helpful for the investigator
  • How long do you require access to this information?
    • Sponsor should be submit the information needed with the application at the time of submission
    • Needs to be submitted as a PDF
  • Can we pilot the interactive approach with Kassa?
    • We would like to get feedback on the alternative approach
    • If we move forward we have to use interactive tool to assist and then test out the Framework
  • Kassa will be happy to be point of contact for OSI and provide information from their prospective
  • Ross- Request for data set is voluntary will this become mandatory?
    • Kassa- Sponsor who wishes to submit can, we encourage sponsors to submit
    • Michael - Working on the feedback from PhUSE WG and CDISC on some of the variables we got back from the WG to make them standard
  • Kassa- Sister company do use IPads to do inspections but we do not in our office
  • Could we build a pro type that Kassa and Michael could share with the OSI team

Next Steps

  • Connect with OSI listing to conduct a pilot
  • Write a proposal and have OSI in mind


  • 2018 Meetings - Next meeting on the 9th January