RWD Lineage: Data Point Traceability for Reliable Real-World Data Using Define-XML

About this session

Part of Session 4, Track C: RWD/DCT (Chair: Donna Sattler, Eli Lilly).

Transforming real-world data into SDTM introduces data loss that's difficult to characterize and impossible to audit without standardized lineage. RWD collected for clinical care and billing does not map cleanly to SDTM, and the complex processing required creates unquantifiable biases that undermine the reliability required for regulatory review. CDISC's RWD Lineage project addresses this by defining a metadata model that captures data point-level lineage for each RWD-derived data point, from source through submission. We propose Define-XML as the representation format, using a namespace extension (rwdl:lineage) that integrates with existing CDISC submission infrastructure. In this presentation, we will talk about the RWD Lineage data model and walk through worked examples of implementation, demonstrating how lineage metadata is generated and propagated through RWD to SDTM transformations. Standardized lineage enables provenance to be combined across disparate data sources and provides a common foundation for validation tooling, audit workflows, and quantification of transformation performance.

Speakers

• TN

  Tasha Nagamine

  Droice Labs

  Speaker

• AU

  Anita Umesh

  Droice Labs

  Speaker