Proposed Future Changes to the SDTM

The following changes are proposed for 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.

The findings variable --LOBXFL was introduced in SDTM v1.7. In the accompanying SDTMIG v3.3, for domains where --BLFL had been included as an expected variable, --BLFL was made permissible, while --LOBXFL was added as an expected variable. Future deprecation was not announced in SDTM v1.7 in order to provide a sufficient transition period. Deprecation in the next version of the SDTM with an accompanying SDTMIG is proposed as this should provide a sufficient transition period.

As a findings variable, --MODIFY was originally included for use in the Physical Examination (PE) domain in the SDTMIG to support coding of an abnormality recorded as a result of a physical examination. However, abnormalities found during a physical examination are now more commonly recorded as events in the Medical History (MH) domain or the Adverse Events (AE) domain, where the full range of coding variables are available. This is consistent with the best-practice scenario described in the Clinical Data Acquisition Standards Harmonization Implementation Guide (CDASHIG). After --MODIFY is deprecated as a Findings qualifier, an implementer coding abnormalities found at a physical exam will not be able to represent coding in the PE domain, but will be able to represent coding in the appropriate Events domain. No use cases other than in the PE domain have been identified for --MODIFY as a Findings variable.

The rationale for removing --BODSYS as a qualifier for use in clinical trials is the same as the rationale for removing --MODIFY. If deprecated, the variable will still be available for use in nonclinical trials, where it has been used to classify the body system of the organ represented as a value of --SPEC.

The variable TIRL was included in the TI domain in anticipation of developing a way to represent eligibility criteria in a computer-executable manner. However, such a method has not been developed, and it is not clear that an SDTM dataset would be the best place to represent such a computer-executable representation.