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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).
Forms Data Format is defined in the PDF specification (since PDF 1.2). The Forms Data Format can be used when submitting form data to a server, receiving the response, and incorporating it into the interactive form. It can also be used to export form data to stand-alone files that can be imported back into the corresponding PDF interactive form.
The Data Documentation Initiative (also known as DDI) is an international standard for describing surveys, questionnaires, statistical data files, and social sciences study-level information. This information is described as metadata by the standard.
Data can be seen as the smallest units of factual information that can be used as a basis for calculation, reasoning, or discussion. Data can range from abstract ideas to concrete measurements, including, but not limited to, statistics. Thematically connected data presented in some relevant context can be viewed as information.
DDI is an open metadata specification and covers the full data life cycle from planning through to dissemination and archiving data. It is most popularly used for social statistics micro data but is not limited to this subject area. There are some examples online where these two standards are in use in proprietary data form.
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"Use of data requires knowledge about the different sources of uncertainty. Measurement is a process. Is the system of measurement stable or unstable? Use of data requires also understanding of the distinction between enumerative studies and analytic problems." "The interpretation of results of a test or experiment is something else.