SUPP to NSV: Transforming Data Representation for Improved Reviewer Utility

About this session

Part of Session 5, Track A: Foundational Standards - Advanced Standards (Chair: Srinivasa Rao Mandava, Merck).

Ever since the advent of SDTM standards, non-standard data has been mapped using the vertical structure outlined in Supplemental Qualifier (SuppQua or Supp) datasets. This has caused issues sometimes when the data needs to be merged back with parent domains and used for analysis further down the data reporting process. That is going to change majorly with the release of the new version of SDTM: Model v3.0 and IG v4.0. This paper describes the transformation from vertical to horizontal structure for mapping non-standard datasets to the newer, more efficient Non-Standard Variables (NSV) datasets in SDTM. This would enable the direct integration of non-standard data into General Observation class domains for easier viewing and metadata application, thereby streamlining submissions by reducing structural limitations and promoting consistency within SDTM standards.

Speakers

• SR

  Soumya Rajesh

  IQVIA

  Speaker

• SM

  Srinivasa Rao Mandava

  Merck

  Chair