SDTM Implementation Guide (IG)-PGx v1.0 Provisional describes standards to guide the organization, structure and format of gene-related tabulation datasets submitted as part of a product application, such as a new genetic test, to a regulatory agency. SDTMIG-PGx v1.0 supports the structured capture and reporting of genetic changes associated with diseases or other conditions, called genetic biomarkers, from patients and of the microorganisms that comprise patients’ microbiomes. It contains information on biospecimen handling for isolation of genetic material and many examples of genetic variation, genotyping and gene expression data formatted using SDTM.
SDTMIG-PGx v1.0 has been released for provisional use, since it introduces new variables and constructs that will be added to the forthcoming SDTM v1.5, and to allow operational testing and evaluation of this standard by the CDISC user community. It is also available in the CDISC SHARE global electronic standards metadata repository, in an Excel version available for download in eSHARE in the Members Only Area.