Sentinel Common Data ModelExternal Link Disclaimer OHDSI Observational Medical Outcomes Partnership (OMOP) Common Data ModelExternal Link Disclaimer Informatics for Integrating Biology and the Bedside (i2b2)External Link Disclaimer / Accrual to Clinical Trials (ACT) Common Data ModelExternal Link Disclaimer Patient-Centered Outcomes Research Network (PCORnet) Common Data ModelExternal Link Disclaimer United States Core Data for Interoperability (USCDI) Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR)External Link Disclaimer Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM)External Link Disclaimer CDISC SDTM COVID-19 companion guideExternal Link Disclaimer U.S. Department of Veterans Affairs Electronic Health Record (EHR) System National Cancer Institute (NCI) Cancer Data Standards Registry and Repository (caDSR)

Common Data Model Harmonization (CDMH) and Open Standards for Evidence Generation

4The solution, using the Adapter AnalogySentineli2b2/ACTOMOPPCORNET▪Different countries use different “outlets”.▪There is a need for travel adapters.The Solution: ▪Use a converter between various adapters.▪Allow researchers to ask a question once and receive results from many different sources using a common agreed-upon standard structure, or a Common Data Model.

Sentinel, PCORnet versions 3.1 and 4.0, OMOP and i2b2/ACT

RWD leveraging Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) via the FDA Gateway