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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 collection fields may be added to the applicant's CRF from the CDASH Model, the SDTM, or created by the applicant using guidance in the TIG.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-361

Prior to adding fields from the CDASH Model, the SDTM, or considering a new applicant-defined collection 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. 

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-410

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