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Can add SDTM fields as needed - (not derived and assigned) - Chris to update

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 fields may be added from the CDASH Model, the SDTM, or created using guidance below.

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 existing domain 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. 

The Once confirmed, the overall process for extending metadata is as follows:

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