Jordan's CT Page and SDS Project Tracker

SDTMIG 3.4

• Resolve IS and PK JIRA Issues
• Insert statement on when NHOID should be used in examples 6-9 (waiting for Jon N review)
  

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

• Clean up and upload example: Interferon-Gamma Response Assays: ELISA and ELISPOT
  
• Clean up and upload example: IS/MB/OI Examples