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  • ADaM datasets and associated metadata must clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study following the ADaM. 
  • Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-604
    ADaM datasets and associated metadata must provide traceability to show the source or derivation of a value or a variable (i.e., the data's lineage or relationship between a value and its      its predecessor(s)). The metadata must identify when and how analysis data have been derived or imputed.
  • ADaM datasets must be readily usable with commonly available software tools.
  • ADaM datasets must be associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.
  • ADaM datasets should have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready."
  • ADaM datasets contain the data needed for the review and re-creation of specific statistical analyses. It is not necessary to collate data into analysis-ready datasets solely to support data listings or other non-analytical displays.

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