CDISC-STDM

CDISC FDA study data submission standard.

Definition

SDTM v3.x current version (SDTMIG Implementation Guide v3.4 published 2021). Structural domains: Special Purpose (DM, CO, SE, SV, SUPP), Interventions (CM, EX, EC, AG, ML), Events (AE, MH, DS, DV, BE, BS, CE, HO), Findings (BG, BS, CV, DA, DD, EG, IE, IS, LB, MB, MI, MK, MS, NV, OE, PC, PE, PP, QS, RE, RP, RS, SC, SS, TR, TU, UR, VS). SAS V5 XPT mandatory format for FDA submission. Tools: SAS, R cdisc-libraries, Pinnacle 21 Enterprise validator.

Origin

CDISC founded 1997 ; SDTM v1.0 published 2004 ; SDTMIG v3.0 published 2009 ; v3.4 published 2021 ; FDA CDISC submission mandate 2016 (Section 745A FDASIA).

Example in context

Pfizer submits a vaccine NDA to FDA with ~50 SDTM domains in SAS XPT ; Pinnacle 21 Enterprise validates conformance before submission ; 80% reduction in RTF requests.

Related terms

• CDISC CDASH — complementary collection standard.