SD2282 - A Expected THERAREA Value?

Pinnacle 21 Support SDTM
1

Hi Bryce,

So far, there is no standard CT for Therapeutic Area. You may contact FDA reviewers assigned to your submission.

Kind Regards,
Sergiy

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2

SD2282: Missing THERAREA Trial Summary Parameter. ‘Therapeutic Area’ (THERAREA) record must be populated in Trial Summary (TS) domain. It is an ‘FDA Desired’ parameter listed in the Technical Conformance Guide (TCG).

I got this message when I try to validate one of my TS domains, I thought the field of TSVAL when TSPARAMCD=“THERAREA” is a free text field, yet it is not.

My question is that, is it truly not a free text field? If not, is there convention for this value, any TSVALCD and TSVCDVER should be associated with?