Version 1.0 of SDTMIG-PGx is a provisionally published standard that guides the organization, structure and format of gene-related tabulation datasets submitted as part of a product application to a regulatory agency. SDTMIG-PGx provides guidance on the implementation of the SDTM for biospecimen and genetics-related data, including but not limited to: biospecimen collection and handling, quality data, genetic findings, and genetic biomarkers.