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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.
new applicant-defined collection fieldsJira 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. Once confirmed, determine whether adding a field from the CDASH Model will fit the need or, if not, whether using a variable from the SDTM will fit the need. If adding a field from the CDASH Model or SDTM meets the need, then a new field will not be created
. New fields will only be created when data are not in scope for a field defined in the CDASH Model or a variable defined in the SDTM. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-410
Once confirmed, the overall process for extending metadata is as follows:
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