and references both Metadata and Admin data. Define-XML Define-XML supports the interchange of dataset metadata for clinical research applications in a machine-readable format. An important use case for Define-XML is to support the submission of clinical trials data in CDISC SDTM, SEND or ADaM format to regulatory authorities. The key metadata components to support submissions are: Dataset definition Dataset variable definitions Controlled Terminology definitions Value list definitions Links to supporting documents Computational method definitions Comments definitions Define-XML can also be used to describe proprietary, non-CDISC dataset structures. The Define-XML model is implemented using extensions to the CDISC Operational Data Model (ODM) XML schema. The current version is 2.0 published on the CDISC website. CTR-XML Clinical Trial Representation allows representing basic characteristics of a clinical trial, such as study sponsor, study name, size of the trial (number of participants). The standard was first introduced in 2016. BRIDG CDISC BRIDG model is a unifying model of the domain of clinical research and research studies. It defines basic elements such as investigator, subject, study, intervention. It is used to keep all standards consistent. It was first introduced in 2006 with version 2 released in 2008. It can be obtained as UML model as well as .OWL format. SHARE CDISC SHARE (Shared Health and Clinical Research Electronic Library) is a metadata repository that supports the development, governance, publishing, and consumption of CDISC standards in human and machine-readable formats. SHARE helps users find, understand, and use rich metadata (i.e., research concepts, data elements and attributes, the relationship among data elements, properties in a relationship, and controlled terminologies) relevant to clinical studies more efficiently and consistently. With all this information in a single repository, SHARE will improve integration and traceability of clinical data end-to-end, from protocol through analysis. SHARE will provide a collaborative standards development environment that will improve quality, integration, and consistency across CDISC standards. CDISC-registered solutions providers CDISC maintains a list of solutions providers, subject matter experts and consultants deemed to have sufficient knowledge and experience implementing the various CDISC standards. ODM and EDC integration Electronic data capture (EDC) systems can be certified as compliant with the Operational Data Model (ODM) by CDISC. There are two main types of integration, ODM Import and ODM Export. ODM import Full import allows importing of ODM-formatted clinical data (MetaData and Data). MetaData only import allows only the importing of MetaData. This is useful for setting up the