I'm working on TS domain for study. I see confusing guidance from CDISC definitions for ACTSUB and SSTDTC
SSTDTC: The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included.
ACTSUB: Actual number of subjects enrolled; may include subjects who were not randomized.
My question is: Do we count subjects who participated in study but were not randomized due failing eligibility criteria for ACTSUB?
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I'm working on TS domain for study. I see confusing guidance from CDISC definitions for ACTSUB and SSTDTC
SSTDTC: The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included.
ACTSUB: Actual number of subjects enrolled; may include subjects who were not randomized.
My question is: Do we count subjects who participated in study but were not randomized due failing eligibility criteria for ACTSUB?