Legacy Data Conversion Plan & Report Meeting Minutes 13 December 2017

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2017-12-13

Agenda

  • Discuss example documents.

Attendees

  • Helena Sviglin
  • Jane Lozano
  • Kristin Kelly
  • Lisa Brooks
  • Sandra Minjoe
  • Soumya Rajesh
  • Tony Chang

Meeting Discussion

  • The first example document that Kristin created was updated to move the information into an appendix. The content did not change.
  • The second example document was discussed (SDTM 3.1.1 data was converted to a standard supported by FDA). The example was updated to move the information into an appendix. The following changes were suggested:
    • Include the SDTM and ADaM model and IG wherever they are referenced. This would apply to the first example document as well.
    • Add a reference to the website that contains the Data Standards Catalog (similar to what is in the SDSP).
    • Section 3 of the main part of the guide - change the word 'section' to 'appendix'. This would apply to the first example document as well.
    • Remove the references to the MedDRA and WHODrug lookup tables.

Action Items

  • [Kristin] Update second cSDRG example documents.
  • [Dave and his sub-group] Start on Completion Guidelines.