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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.
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]
Continuity of Care Document - The Continuity of Care Document (CCD) represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient's healthcare, covering one or more healthcare encounters. The primary use case for the CCD is to provide a snapshot in time containing the germane ...
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.
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]