Legacy Data Conversion Plan Meeting Minutes 3 June 2014

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2014-06-03

Agenda

  • Introductions
  • Meeting Schedule
  • Review initial template

Attendees

  • Jane Lozano
  • Jingyee Kou
  • Mario Salas
  • Claudia Meurer
  • Erica Davis
  • Kristin Kelly


Meeting Discussion

  • Team discussed the creation of the plan. The plan would be applicable when legacy data is converted to standard data (e.g. CDISC, SDTM, SEND, and ADaM). It applies to a compound and within the document the studies would be documented. It doesn't have to be a very long document as the reviewer can look at the Study Data Reviewer's Guide (SDRG) for more details. The intention is to document at a high level how the data was converted (the process) and the results of the conversion along with any outstanding issues. This could include data that could not be converted or put into supplemental domains.


Action Items

  • [Mario] Send an example of a conversion document that he has created to the team to review prior to the next meeting.
  • [ALL] Think of sections that you would like to work on for the next meeting.
  • [Jane] Schedule upcoming meetings.