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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:
This is the file index.xml in the submission sequence number folder. For example: ctd-123456/0000/index.xml The purpose of this file is twofold: Manage meta-data for the entire submission; Constitute a comprehensive table of contents and provide corresponding navigation aid.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
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]
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 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.
In the second stage of meaningful use, the CCD, but not the CCR, was included as part of the standard for clinical document exchange. [9] The selected standard, known as the Consolidated Clinical Document Architecture (C-CDA) was developed by Health Level 7 and includes nine document types, one of which is an updated version of the CCD. [2]
Depiction of a set of interrelated FHIR resources. Each resource consists of data elements that describe the healthcare concept. FHIR is organized by resources (e.g., patient, observation). [10] Such resources can be specified further by defining FHIR profiles (for example, binding to a specific terminology).