FDA's CDER has recognized a critical need for the development of standards to accommodate the virology data accompanying submissions in multiple therapeutic areas. To address this need, CDER has worked with CDISC to develop a possible solution. Two new SDTM domains to house virologic genotypic (VG) and phenotypic (VP) are proposed. The VG and VP domains are structured as Findings domains that can stand alone or be folded into the constellation of domains called PGx that are currently being drafted. While PGx is designed to house subject-level data, VP and VG are intended to house pathogen-level data.
For More information please click here: CDISC: Public Review: SDTM Virology Draft Domains
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