Brussels, Belgium - SDTM Advanced (IN-PERSON)

Course Description

This SDTM Advanced training in Brussels now includes an extra half-day instructor-led hands-on implementation pilot. This special training pilot will begin with the existing 1 1/2 day SDTM Advanced training, followed by a deep-dive implementation activity led by two instructors. This half-day hands-on activity pilot will consist of instructor-guided group activities covering topics from CRF annotation, creating and validating SDTM-conformant spreadsheets and using CORE.

The SDTM Advanced Topics training explores topics beyond SDTM Theory and Application, including complex SDTM modeling. Course topics are drawn from real-world examples identified through the standard development process as well as by the CDISC user community and our expert SDTM instructors.

Topics include the following: Timing Variables, Advanced Controlled Terminology Implementation, Findings About and Outcomes of OCCUR, The EX and EC Domains, Changes in Severities, Linking Data, Conformance Rules and Requirements, Associated Persons, Biospecimen Events, Lab-related data, --CAT & --SCAT Variables, Drug Classes, The 'Collected Summary Result Type' Variable

Prerequisites

• A working-level understanding of clinical research
• Practical implementation experience with SDTM standards (at least one year experience is recommended)