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The Case Report Tabulation Data Definition Specification (define.xml) draft version 2.0, the oldest data definition specification, is part of the evolution from the 1999 FDA electronic submission (eSub) guidance and electronic Common Technical Document (eCTD) documents specifying that a document describing the content and structure of included ...
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).
The terms data dictionary and data repository indicate a more general software utility than a catalogue. A catalogue is closely coupled with the DBMS software. It provides the information stored in it to the user and the DBA, but it is mainly accessed by the various software modules of the DBMS itself, such as DDL and DML compilers, the query optimiser, the transaction processor, report ...
A common type of software document written in the simulation industry is the SDF. When developing software for a simulator, which can range from embedded avionics devices to 3D terrain databases by way of full motion control systems, the engineer keeps a notebook detailing the development "the build" of the project or module.
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Parsed Character Data (PCDATA) is a data definition that originated in Standard Generalized Markup Language (SGML), and is used also in Extensible Markup Language (XML) Document Type Definition (DTD) to designate mixed content XML elements.
Metadata is often defined as data about data. [2] [3] [4] It is “structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use or manage an information resource”, especially in a distributed network environment like for example the internet or an organization. [5]
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