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To use standards for collection and tabulation, compare the nature or role of the data to the scope of a domain. Domain names provide short descriptions of intended scope and may be used to narrow down which domains to consider. A domain standard may be used when the nature of the data and the domain scope are aligned.Observations will be collected using standardized collection fields when applicable and represented as rows in tabulation datasets. Each observation is described by a series of data points, which correspond to applicable data collection fields and variables in a tabulation dataset. A data collection field and/or tabulation variable may be used when the subject matter of a data point and the scope of a field and/or variable are aligned. The majority of data for a submission will be in scope for domains based on the General Observation Classes and a subset of Special Purpose domains described domains described in the SDTM. Given this, referring to both the CDASH Model when applicable and the SDTM is highly recommended when using domains to support understanding of intended scope and to inform extensions and creation of custom domains when needed.
The design of analysis datasets is generally driven by the scientific and medical objectives of the study.
A A fundamental principle is that the structure and content of analysis datasets must support clear, unambiguous communication of the scientific and statistical aspects of the study. The purpose of ADaM is to provide a framework that both enables analysis of the data and allows reviewers and other recipients of the data to have a clear understanding of the data’s lineage from collection to analysis to results. ADaM provides the core and defines the spirit and intent of its concepts and standards. The model outlines the fundamental principles to follow in constructing analysis datasets and related metadata. Four types of metadata—analysis dataset metadata, analysis variable metadata, analysis parameter value-level metadata, and analysis results metadata—are described in ADaM. To establish which components are required in a submission, review current relevant files provided by the agency to which the submission is being sent. Other relevant documentation might include the study protocol, the statistical analysis plan (SAP), mock shells that define desired outputs, and any dataset specifications that have been defined.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-74
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