Real World Data Lineage Implementation Guide
Project Description |
This project aims to develop practical guidance for documenting end-to-end data lineage for real-world data (RWD) regulatory submissions. While FDA and EMA guidance emphasise the importance of tracing data from source to submission, there is limited direction on how to document lineage throughout the full data transformation process. Existing initiatives, such as the CDISC RWD Lineage project, focus primarily on capturing source information within Define-XML but do not fully address transformations such as data selection, cleaning, standardisation, attrition, imputation, and AI-driven processing. The project will create guidance that helps sponsors consistently document, validate, and demonstrate RWD lineage from data acquisition through SDTM and submission. Areas of focus include defining the information required to tell the complete lineage story, ensuring traceability and immutability, addressing AI-related processes, supporting backward data tracking, and aligning with CDISC RWD lineage standards. The guidance will promote more structured, transparent, and regulator-friendly RWD submissions. |
Project Leads | |
|---|---|
Berber Snoeijer, ClinLine | |
Ingeborg Holt, Orizaba Solutions | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |