Statistical Programmer | SAS Expert | Specializing in CDISC Standards (SDTM, ADaM) | Clinical Data Analysis & Validation | Pharma & Healthcare Industry Professional
Difference between RFSTDTC, RFENDTC and 𝐑𝐅𝐗𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐗𝐄𝐍𝐃𝐓𝐂 𝐑𝐅𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐄𝐍𝐃𝐓𝐂 indicate a patient's initial and final exposure to a study drug or treatment, crucial for analyzing patient involvement and events within the study. They are expected to be populated for all randomized subjects, as they denote the beginning and end of a patient's exposure to the study drug. However, understanding the patient's study involvement timeline is crucial for event analysis. In some studies, the reference period starts to vary due to factors like washout periods or required medical procedures during screening. In such cases, RFSTDTC defaults to the enrollment date. For studies where many subjects aren't expected to be treated, a different milestone may serve as the starting reference point. RFSTDTC (and RFENDTC) will be null only if a subject experiences screen failure, isn't assigned to a treatment arm, or is randomized but doesn't receive treatment. 𝐑𝐅𝐗𝐒𝐓𝐃𝐓𝐂 and 𝐑𝐅𝐗𝐄𝐍𝐃𝐓𝐂 variables specifically represent the date and time of the first and last study exposure to the protocol-specified treatment or therapy, respectively. These values are consistent with those from SDTM.EX sources.
What are the scenarios where the date/time of protocol specified treatment differ from the RFSTDTC....or how difference arise in both RFSTDTC and RFXSTDTC variable date value..means what r the conditions in which the both are not same ..
RFSTDTC - study treatment (either placebo or investigational product for parallel study design) RFxSTDTC (protocol specified treatment - both placebo and investigational product for crossover study design)
Good summary! Hopefully this helps those newer to SDTM to understand a little better.
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8moHi Vijay...what is the purpose of using two variables here like RFSTDTC and RFXSTDTC...like RFSTDTC we using for investigational drug and RFXSTDTC using for either investigational or reference drug defined in protocol..is this RFXSTDTC variable used for capturing the date for reference drug first exposure....am I right...