Illustrates Domains
DI
Illustrates Variables
SPDEVID
DIPARMCD
DIPARM
DIVAL
Content
This example shows how to represent data from test kits used to evaluate a multigene panel test and RNA in an oncology study. The sponsor may include the number of genes evaluated in the assay in the SPDEVID name for ease of review, as there are many tests with similar names but a different number of genes evaluated.
Sponsors may collect information on the test kit used to perform the precision medicine testing. The variable DIPARMCD = "DEVTYPE" identifies the gene panel used to generate the result. Note when DIPARMCD = "DEVTYPE", DIVAL is assigned using Global Medical Device Nomenclature (GMDN) terminology, when possible. In this example, GMDN terminology is for illustration purposes only and does not represent valid GMDN values, which are copyrighted. More information on the use of GMDN can be found in the SDTMIG for Medical Devices (available at https://www.cdisc.org/standards/foundational/medical-devices-sdtmig/).
The sponsor did not include any other information about the multigene panel test, as the necessary information was available in the product label.