CDISC started with a primary focus on clinical trial data for regulatory submission and has expanded over time to support standards across the study data lifecycle, including study protocol, collection, tabulation, analysis, and submission. There has been increased interest over the last decade in leveraging data originating from Real World Data (RWD) sources like Electronic Health Records (EHRs), observational studies, digital health technologies (wearables), patient reported outcomes, payers and other sources. Because these data are typically unstructured and lacking in semantics, the use of standards is needed to generate reliable data for decision making. CDISC has a history of collaborating with academic and industry organizations to expand and demonstrate how CDISC standards can be used to support data stemming from RWD sources. This presentation will introduce the audience to some of the work CDISC has done to support the use of CDISC standards by academia.

The session will provide an overview of the RWD landscape and several CDISC activities:
・Summary of the CDISC RWD Connect Delphi Survey published in 2021
・Overview of several CDISC initiatives including FHIR to CDISC mapping, Digital Health Technologies Standards, and XShare, a European initiative to build a single patient record
・Summary of the CDISC white paper “Considerations for using CDISC for Observational Studies”
・Overview of RWD resources currently available that support adoption of standards by academia and opportunities to continue to expand and provide education on CDISC standards to enable academic research.