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changes.mady.by.user Matthew Warren

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changes.mady.by.user Diane Wold

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The following changes are proposed for the next a future version of the SDTM:

  • The variable --BLFL will be considered for deprecation as a qualifier for findings class domains.
  • The variable --MODIFY will be considered for deprecation as a qualifier for findings class domains. The variable --MODIFY will remain as a qualifier for the events and interventions classes.
  • The findings variable --BODSYS may be restricted to use in nonclinical trials.
  • The variable TIRL will be considered for removal from the Trial Inclusion/Exclusion (TI) domain.
  • The variable --TSTDTL may be made domain-specific, for use only in the Microbiology Specimen (MB), Microscopic Findings (MI), and Genetic Findings (GF) domains.

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