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If data are in scope for a domain defined in this guide but not all data can be collected using the domain's collection fields, then new applicant-defined collection fields may be added to the applicant's CRF from the CDASH Model, the SDTM, or created using guidance in the TIG.

Prior to adding fields from the CDASH Model, the SDTM, or considering a new field, confirm that none of the fields in the domain will fit the need. Fields may be added from the CDASH Model, the SDTM, or created only when data are different in nature and are not in scope for collection fields in this guide. 

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