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Understanding RFXSTDTC and RFSTDTC in the Demographics (DM) Domain

Understanding RFXSTDTC and RFSTDTC in the Demographics (DM) Domain Understanding RFXSTDTC and RFSTDTC in the Demographics (DM) Domain Introduction In the context of clinical trials, accurately capturing key dates related to subject participation is critical for understanding the timeline of the study. The SDTM (Study Data Tabulation Model) Demographics (DM) domain includes several variables that record these key dates, two of the most important being RFXSTDTC and RFSTDTC . Although they may seem similar, these variables have distinct meanings and uses. This article explains the difference between RFXSTDTC and RFSTDTC , with detailed examples to illustrate their appropriate use. Definitions RFSTDTC (Reference Start Date/Time of Study Participation) RFSTDTC refers to the date and time when the subject officially started participating in the study. This is usually the date of randomization, the first study-sp...