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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:
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange. [12] The standard was jointly published with ISO as ISO/HL7 27932.
Clinical Data Interchange Standards Consortium; Clinical Document Architecture; COLLADA: a standard for exchanging digital assets among various graphics software applications; Common Alerting Protocol (CAP) CXML: a protocol intended for communication of business documents between procurement applications, e-commerce hubs and suppliers
The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies.
The Clinical Data Interchange Standards Consortium, a global, multidisciplinary, non-profit organization, has established standards to support the acquisition, exchange, submission and archiving of clinical research data and metadata. CDISC standards are vendor-neutral, platform-independent and freely available from the CDISC website.
An XML element in a CDA supports unstructured text, as well as links to composite documents encoded in pdf, docx, or rtf, as well as image formats like jpg and png. [3] It was developed using the HL7 Development Framework (HDF) and it is based on the HL7 Reference Information Model (RIM) and the HL7 Version 3 Data Types. [citation needed]
The Clinical Data Interchange Standards Consortium leads the development of global, system independent data standards which are now commonly used as the underlying data structures for clinical trial data. These describe parameters such as the name, length and format of each data field (variable) in the relational database.
FHIR builds on previous data format standards from HL7, like HL7 version 2.x and HL7 version 3.x. But it is easier to implement because it uses a modern web-based suite of API technology, including a HTTP-based RESTful protocol, and a choice of JSON, XML or RDF for data representation. [1]