The CDASHIG MB domain is used to represent microbiology findings from tests or measurements performed on collected biological specimens, such as the identification, quantification, and other characterization of microorganisms. Any drug susceptibility testing is represented in the Microbiology Susceptibility (MS) domain. The MB domain typically includes organisms found (e.g., non-host organisms identified including bacteria, viruses, parasites, protozoa, and fungi), gram stain results, and organism growth status. Culture characteristics may also be included (e.g., growth/no growth, colony quantification measures, colony color, colony morphology).
Central Processing - In this scenario, biological specimens are taken at the site, sent out for processing, and results are provided directly to the sponsor (not recorded on the CRF). This scenario also applies when results are captured directly via an electronic device and not recorded on the CRF. CRF data are captured at the site for tracking/header reconciliation. The fields for test results are not defined here, as these data are not part of the CRF.
This example is for a COVID test. The user will need to update the questions, as appropriate.
MBGRPID is not present in the example CRF; it can be included in the SDTM dataset, as appropriate.