domains and examples of non-clinical (animal) data based on the structure and metadata defined by the SDTM. Analysis Data Model (ADaM) Defines dataset and metadata standards that support statistical analyses and traceability. ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Operational Data Model (ODM) The highlights of ODM: includes an audit trail, utilizes XML technology, machine- and human-readable, all information are independent of databases, storing of ODM is independent of hard- and software. Laboratory Data Model (LAB) The Lab standard is used for the exchange of laboratory data between labs and CROs Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) Defines a minimal data collection set for sixteen safety SDTM Domains, harmonizing element names, definitions and metadata. The objective is to establish a standardized data collection baseline across all submissions. CDISC Terminology Defines controlled terminology for SDTM and CDASH, provides extensible lists of controlled terms designed to harmonize data collected across submissions. Individual standards Operational Data Model (ODM) The CDISC Operational Data Model (ODM) is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. ODM extensions have been developed to create a number of additional CDISC standards, including Define-XML, Dataset-XML, SDM-XML, and CTR-XML and future planned standard Protocol-XML. ODM is an XML based standard and it is an XML schema that provides a number of constructs for modelling electronic Case Report Forms (CRFs). ODM is often combined with the Study Data Model standard to more fully model trial arms or trial activities. ODM is also used in sending forms data from a clinical trial system to an electronic health record (EHR) system. The ODM schema is generally divided into three categories of data: Metadata, Admin data, and Clinical data. Metadata describes the structure of the eCRFs within the study, and how they relate to scheduled visits. Admin data contains references to users, locations, and any additional non-structural and non-clinical reference data. Clinical data contains all eCRF item values