Map It Once, Automate Everything: A Live Journey Through CDISC 360i — From Digital Protocol Activity to SDTM Record

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management.

What if you could map a protocol activity to a Biomedical Concept once — and have your SDTM specification, CRF guidance, and automated transformation generated instantly?

That’s the promise of CDISC 360i, and this session shows it working in practice.

Join Tamer Chowdhury, Chair of the ACDM Technology Data Management Expert Group and Carolyn McNamara, for a hands-on demonstration that brings the ACDM white paper “Modernization of Clinical Data Flow” to life. Using a working prototype, Tamer will walk through the complete data flow journey — from digitizing a Schedule of Activities with activities and timepoints, through mapping each activity to CDISC Biomedical Concepts, reviewing Data Element Concepts and topic variables that link to SDTM domain records via Dataset Specialization, all the way to automated CRF alignment with CDASH and in-house data standards.

The session includes a live tour of the CDISC Library — importing Biomedical Concepts, Dataset Specializations, SDTM, CDASH, and Controlled Terminology — demonstrating how standards metadata becomes the engine that eliminates weeks of manual mapping.

Key highlights:

• Live digitization of a Schedule of Activities with activities, visits, and timepoints
• Activity-to-Biomedical Concept mapping with Data Element Concepts
• Topic variables and Dataset Specialization linking BCs to SDTM domain records
• CDISC Library walkthrough: importing BCs, SDTM, CDASH, and Controlled Terms
• CRF-to-Biomedical Concept alignment including CDASH and in-house standards
• From white paper vision to working reality — the poster comes alive

Whether you’re a data manager, standards lead, or clinical programmer, this session will change how you think about clinical data flow.