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Attendees: Jeff, Priya, Sam

Apologies: Jeff, Trisha, David, Steve, Jeff


Project Plan

  • End project - Saftey displays
  • Give the analyses dataset which are used to generate the end product
  • Priya can come up with displays and send to the team
  • Once we agree on these we can look into the data sets
    • Bring the EHR in
  • Still have to submit SDMT
  • Look into trends over time as we did not previously look into this - how do AEs model
  • FHIR resources AE - if we do some safety analyses we should not that this is a work in progress
  • Priya to look into AE resources in her company
  • Pick a drug and relate it to the adverse event
  • Look into labs interchange from baseline as we can check the labs test line
  • We could look at some ADaM data sets in addition to the reporting
  • There are also displays metadata
  • CDISC - are going to start working on a real world strategy


  • Figure out the displays we may want to reproduce and review at the next meeting