CDISC Define-XML Metadata Standard

Context:
- It can (typically) be used in conjunction with other CDISC Standards, such as the Study Data Tabulation Model (SDTM).
- It can (typically) help explain what each variable represents, how the data should be interpreted, and how the different variables relate.
- It can (typically) provide a comprehensive, standardized way to describe the structure of these datasets.
- It can (often) be required by regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in electronic submissions of clinical trial data.
- It can (often) used in Clinical Trial Data Exchange.
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Example(s):
- an electronic submission to the FDA for a new drug application using Define-XML to describe the structure of the clinical trial data.
- a clinical trial dataset structured and described according to the Define-XML standard.
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Counter-Example(s):
- a clinical trial dataset that is submitted to the FDA without using Define-XML, leading to difficulties in interpreting the data.
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See: CDISC, Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM).

References

(CDISC, 2021) ⇒ https://www.cdisc.org/standards/foundational/define-xml
- QUOTE: "Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM."