The CDASHIG MI domain collects histopathology findings and microscopic evaluations of tests and measurements performed on collected biological specimens which do not have specialized domains (e.g., MB, MS) for their results.
Central Processing - In this scenario, subject 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 tuberculosis test. The user will need to update the questions, as appropriate.