A Validation Macro to Check Compliance of CDISC SDTM Data.pdf

A Validation Macro to Check Compliance of CDISC SDTM Data Hany Aboutaleb, Biogen Idec, Cambridge, MA Abstract: The CDISC SDTM Implementation Guide provides specifications for 30 domains or more and new domains are always being developed . It is important to check the CDISC website for the latest updates before you begin a new project. This validation macro will check the compliance of the SDTM domains as per the most recent SDTM Implementation Guide (SDTM IG) plus our company specific domains. This check will reduce risk of delays in the submission review process. The checks include: domain name, domain description, variable name, variable order, variable label, variable type, and variable length. Background: Clinical d atabases requ ire some processing/ mapping prior to being 100% SDTM compliant submission ready files. A valid ation plan should to be in place to ensure that the data converted into SDTM can support the submission. Getting the data into SDTM compliant files will save money and time. It is very important to develop a tool to validate SDTM d ata contents and attributes for all projects in order to foster standards and ensure high quality in mapping clinical data to CDISC SDTM requirements. A master SDTM excel file can be generated using the d ocument in SDTM version 3.1.1 or 3.1.2 at www.cd . The sheet named v311 d isp lays Sequence For Order, Observation Class, Domain Prefix, Variable Name (minus domain prefix), Variable Name, Variable Label, Ty pe, Controlled Terms or Format, Origin, Role CDISC Notes, Core, Reference (See Table 1 below). Table 1 Master SDTM Coders CornerNESUG 2011 UNDERSTANDING the Master SDTM Sheet Domains: The Master SDTM sheet domains are group ed into classes and domains. Each domain is named with two characters. The domains are contained in these classes: Special Purpose, Interventions, Events, Find ings and Trial Design Models. Each domain