Observational Health Data Sciences and Informatics

Many organizations using the OMOP CDM for observational data are also charged with the production and handling of clinical trials data. One common format (that required for FDA submission) is the CDISC Study Data Tabulation Model.

OMOP is fundamentally an observational data model, so the ability to handle data derived from clinical trials may not be a priority. However, the community should consider whether the integration of such data into the CDM would add value. Most of the standard clinical trial domains can be represented in the current CDM, albeit with extensive use of the concept_relationship table. There may also be hybrid approaches to representing clinical data in the CDM while maintaining the study information (eg. subject metadata) separately.

If inclusion of CT data is a priority for community members, it would be worth exploring the SDTM and its relation to the CDM in further detail.