The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical research and related areas of healthcare.
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data.
[10] 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[11] format to regulatory authorities.
The key metadata components to support submissions are: Define-XML can also be used to describe proprietary, non-CDISC dataset structures.
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.