Corpus ID: 13842881

SDTM EX and EC : Considerations When Submitting Exposure Data

  title={SDTM EX and EC : Considerations When Submitting Exposure Data},
  author={Jerry Salyers and TalentMine Kristin Kelly},
  • Jerry Salyers, TalentMine Kristin Kelly
  • Published 2018
  • Per the SDTMIG v3.2, the Exposure (EX) domain should contain only unblinded data for study treatment that was administered to subjects presented in protocol-specified units. Because of this, the Exposure as Collected (EC) domain can be used to collect blinded data during the study for all administrations given, not taken or missed. After the study is unblinded, the EX domain can be derived from EC. The SDTMIG recommends submitting both EX and EC if necessary, though including EC is not required… CONTINUE READING