Understanding EC vs. EX Domains in SDTM: When to Use Each
Understanding EC vs. EX Domains in SDTM: When to Use Each Understanding EC vs. EX Domains in SDTM: When to Use Each In SDTM, the EC (Exposure as Collected) and EX (Exposure) domains are both used to capture data related to drug or therapy exposure, but they serve different purposes depending on how the exposure data is collected and whether the study is blinded or unblinded. Key Updates from PharmaSUG Papers: PharmaSUG 2017 Paper DS08 introduces the historical context of the EC domain, which was established in SDTMIG v3.2 to support the EX domain by providing detailed traceability for exposure data. EC helps capture deviations, titrations, and other variations from planned dosing, especially when the collected data doesn't match protocol-specified dosing. PharmaSUG 2022 Paper DS121 emphasizes the importance of capturing dose modifications using the EC domain, which often occurs in oncology trials. By utilizing EC, sponsors can accurate...