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SD2282 - A Expected THERAREA Value?
SergiyP21
Hi Bryce, So far, there is…
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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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?