Legacy Data Conversion Plan & Report Meeting Minutes 13 December 2017

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  • Discuss example documents.


  • Jane Lozano
  • Kristin Kelly
  • Lisa Brooks
  • Wendy Dobson

Meeting Discussion

  • The example document that Kristin created will be sufficient for the legacy conversions discussed in the TCG. The document that Lisa created with examples of each type of conversion with the conversion data flow and traceability data flow will be included in the completion guidelines.
  • The LDCP section will be part of an Appendix to the cSDRG and ADRG. This is similar to what was done with the SDSP. If the LDCP information is not needed, the appendix does not need to be included in the reviewer's guides.
  • Kristin will work on an example document where SDTM 3.1.1 data was converted to a standard supported by FDA.

Action Items

  • [Kristin] Update current cSDRG example document per the updated template.
  • [Kristin and her sub-group] Create cSDRG example document for the other type of conversion.
  • [Dave and his sub-group] Start on Completion Guidelines.