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SDTMIG 3.4

  •  Resolve IS and PK Issues
  •  Insert statement on when NHOID should be used in examples 6-9

NHOID, defined by the OI domain, should be used to map microorganisms that have been either experimentally determined in the course of a study or are previously known, as in the case of lab strains used as reference in the study. In other words, NHOID is used when the study subject is the microorganism, and when the microorganism is present in the testing sample. In vaccine efficacy studies, a subject’s post-immunization sera is often incubated with a microbial strain of interest, where "functional capacities" of the vaccine-induced antibodies are measured through whether the antibodies can effectively stop (from infection), neutralize and kill the study microorganism of interest, in vitro. Examples of such tests are micro-neutralization, hemagglutination Inhibition and opsonophagocytic killing assays. In these tests, one is measuring the direct effect of the anti-microbial antibodies on the microorganism, therefore, said microorganism is the study subject and should be mapped to NHOID.

Tests that are measuring and quantifying a subject's innate cellular and humoral immune responses to a microorganism or a vaccination agent, such as measurements of activated cytokine- or antibody –secreting cells, or cytokine response assays (i.e. interferon gamma response test), are biological measurements about the human subject. They are not assessments about the microorganism itself, hence NHOID should not be used in these cases.

SDTMIG 4.0

...

• SDTMIG Scope finalization in ~March 2021.

• SDTMIG Internal Review in ~ August/September 2021.

• Public Review in ~ November 2021.

• CT to support SDTMIG Public Review in ~June 2022.

• CT to support SDTMIG publication in ~September 2022.

• SDTMIG publication ~November 2022.

...

For IS/MB: I think we should discuss the possibility of whether new examples can be included in a “CDISC SDTM Example Library”. @Dana, I know we had discussed this as a possible option for the Genomics Team depending on what content is needed for supplemental materials. My understanding is, using this approach, updated examples may be released more frequently and this allows the SDTMIG to be an implementation guide with less time sensitive examples rather than guidance for different data types / therapeutic areas.

For PK Parameters: Can you please put this work on hold for now? Alignment on future standards development for PK is in discussion within CDISC and we expect to have more unified direction for this data early next year.