The provisionally published SDTMIG-PGx v1.0 is currently under review within CDISC. SDTMIG-PGx v1.0 has been released as a provisional standard to allow operational testing and evaluation by the CDISC user community. After a period of review and use by the user community, updated standards for gene-related tabulation datasets are in development and are expected to be released as part of a formal publication.
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.