The CDISC data models will ultimately support the end-to end data flow of clinical trials, from the source(s) into an operational database, through analysis to regulatory submission. The sources of data that are relevant to CDISC vary among patient records (e.g., case report form data), clinical laboratory data, data from contract research organizations, shared data between companies with corporate mergers or development partners, and other sources. Operational Data Modeling (ODM) refers to the standard data interchange models that are being developed to support the data acquisition, interchange and archiving of operational data. Submission Data Modeling (SDM) refers to the standard metadata models being developed to support the data flow from the operational database to regulatory submission.