VISITNUM and EPOCH Meeting Notes 2014-03-17

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  • Introductions
  • Assign Roles
  • Meeting Schedule
  • Background from FDA


  • Dennis Ballinger
  • Ron Fitzmartin
  • Hongfei Guo
  • Tatyana Kotun
  • Trevor Mankus
  • Micky Salgado-Gomez
  • Natalia Smeljanski
  • Helena Sviglin
  • Carol Vaughn

Meeting Discussion

  • Team agreed we would meet every 2 weeks at 8AM (eastern) on Tuesdays, beginning April 8, 2014.
  • Team member roles were assigned and a team leader was appointed.
  • Background of EPOCH/VISITNUM topic from FDA:
Needs of medical reviewer (vs. statistician). Reviewers would like to see the context of an event (temporally) when reviewing rows of data. EPOCH in an SDTM dataset allows for this, 'at a glance' orientation. Generally, EPOCHs are the links that tell you what’s going on in protocol without any gaps in their definition; they are based on key events. Reviewers prefer to see EPOCH populated, where possible, as some may find it very useful.

Action Items

  • [ALL] Review structure of "Best Practices" document on data sizing and how it will be used for this working group's Best Practices topics.
  • [ALL] Think of questions to ask in survey. Follow up action will be to populate in Wiki for team to share their ideas about what the questions should be.
  • [Carol] Send team VISIT/VISITNUM/EPOCH training slides that demonstrate the challenges in populated these variables.