The CDASHIG TU domain represents data that uniquely identifies tumors and lesions (i.e., malignant tumors, culprit lesions, other sites of disease such as lymph nodes). Commonly, tumors/lesions are identified by an investigator and/or independent assessor and classified according to disease assessment criteria. For example, for an oncology study using RECIST evaluation criteria, this equates to the identification of target, non-target, or new tumors. When designing CRFs, it is common that a single CRF is designed to collect both the tumor/lesion identification information and the results of any assessments on these identified tumors/lesions.
The CDASHIG TR domain represents measurements and/or assessments of the tumors and lesions identified in the Tumor/Lesion Identification (TU) domain. When the TR domain is used, there must be a corresponding TU domain present. This multiple-domain approach was developed largely to reduce the need to collect tumor identification information at each assessment (e.g., anatomical location). A unique tumor/lesion identification number (populated in TULNKID/TRLNKID) is used to link the tumor/lesion identification (TU) with the measurement/assessments (TR). When designing CRFs, it is common that a single CRF collects both the identification information and the results of any assessments on identified tumors/lesions.
This example is for a Breast Cancer - RECIST 1.1 - Target Lesions.
The user will need to update the questions, as appropriate.