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If data are in scope for a collection domain dataset defined in this guide, but not all data can be represented using the domain variablesdata collection fields, then custom data collection fields may be represented using variables from the SDTM or in a related supplemental dataset.

How to Create New Data Collection Fields When No CDASHIG Field Has Been Defined

Collection metadata can be extended when new data collection fields

 The used. The naming conventions and other variable creation recommendations in CDASHIG this guide are designed to allow collection of data regardless of subsequent inclusion in the SDTMtabulation datasets, as well as to consistently facilitate transforming the collected data into submission tabulation datasets.

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.

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