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If data are in scope for a collection domain defined in this guide, but not all data can be represented using the domain data collection fields, then custom data collection fields may be used. Naming conventions and other variable creation recommendations in this guide are designed to allow collection of data irrespcective of subsequent inclusion in tabulation datasets.
Prior to creating adding a custom domainfield to a CRF, confirm that none of the existing published domains data collection fields will fit the need.
Prior to adding a custom field to a CRF, the CDASH Model
Prior to adding any new fields to a sponsor's study CRF, the CDASH Model should be reviewed to see if there is a root field that will work for the data collection need.
New data collection fields (not already defined in the CDASH Model) will fall under 1 of following categories.
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