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• The timing of collected observations (e.g., all vital signs measurements will be represented in the Vital Signs (VS) domain irrespective of when measurements occurred)
• How collected data are used (e.g., all vital signs measurements will be represented in VS and a custom "safety" domain will not be created for measurements used to assess safety)
• Data collection methodology 

  Jira
  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-619

  (e.g., all vital signs measurements will be represented in VS irrespective of whether measurements were recorded using separate CRFs, a medical device like a fitness tracker, or an electronic diary.)

Prior to creating a custom domain, confirm that none of the existing published domains will fit the need. Once confirmed, drafting a specification upfront, using conventions in Section 2.8.1, How to Read Domain Specifications, is recommended to ensure expectations for the custom domain are clear. Custom domains and corresponding specifications must be created based on the 3 general observation classes (i.e.,Interventions, Events, Findings) described in the SDTM. In most cases, the choice of observation class appropriate to a specific collection of data can be determined according to descriptions of these classes in the SDTM. The majority of data—which typically consists of measurements or responses to questions, usually at specific visits or time points—will fit the Findings general observation class. 

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