Objective: To allow adequate representation of clinical trial data in OMOP.

First use case: To convert clinical trial data in CDISC SDTM format to OMOP, with a view to allowing trial planning optimization.

Approach: We advocate minimum changes to the OMOP CDM and Standardized Vocabularies because we want to ensure minimum impact on OHDSI tools like Atlas, whilst providing a value-add SDTM-to-OMOP conversion with minimum data loss. We have proposed conventions introducing new concepts and modifiers, but no new CDM tables; and providing guidance for ETL developers where appropriate. Our proposals are built on OMOP CDM v6 and the Oncology extension, with v5.3.1 backward compatibility.

Status:
- Proposals submitted to the OHDSI community in July 2020.
- Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database).

WG Lead: Sonia Araujo, IQVIA, London, UK (sonia.araujo@iqvia.com)

Current Members