Legacy Data Conversion Plan Meeting Minutes 1 July 2014

From PHUSE Wiki
Jump to: navigation, search



2014-07-01

Agenda

  • Continue to review template (starting with Claudia's comments)
  • Assign sections to working group members

Attendees

  • Kristin Kelly
  • Jingyee Kou
  • Jane Lozano
  • Sandra Minjoe
  • Mario Salas

Meeting Discussion

  • The team continued to review the template starting with the document that Claudia sent to Jane with comments. A link was added to slides from the FDA about submitting datasets. The one slide that we discussed shows that when SDTM datasets are created from raw data the analysis datasets should be created from the SDTM datasets and not the raw data. In the case of legacy data conversions in which the analysis datasets were originally created and SDTM datasets are created only (no ADaM created), sponsors should be prepared to submit the raw data. From Jingyee's perspective, she looks at the raw data to ensure it is in the SDTM datasets correctly and also in the analysis datasets. She doesn't see any use in creating a document showing where the data is in SDTM datasets and the corresponding data in the analysis datasets.
  • Kristin will send a template for a table to list the studies that she will send to the team.
  • Jingyee will not be responsible for a section, but will be available to review the document.
  • Section Assignment:
  • 2 (Legacy Data Summary) - Kristin and Jerry
  • 3 (Converted Data Summary) - Mario and Claudia
  • 4 (Conversion Results) - Sandra, Erica, and D'dra

Action Items

  • [Kristin] Send a template for a table to list studies.
  • [Jane] Assign sections to members of the working group.