What is CDISC, and why does every CDM team care about it?
A plain-English introduction to CDASH, SDTM, and ADaM — and how they map to a real fresher's day-to-day work.
CDISC stands for Clinical Data Interchange Standards Consortium. It defines how clinical trial data should be structured, named, and submitted to regulators.
Three layers matter: - CDASH covers what's collected at the point of data capture (CRFs). - SDTM is the standardised "tabulation" model used for submission. - ADaM is the analysis-ready format statisticians use.
For a fresher, your first six months will mostly touch CDASH and SDTM. You won't author standards from scratch — you'll review datasets against them, raise discrepancies, and reconcile.
The fastest way to learn this is to look at real annotated CRFs and a small SDTM dataset side by side. We cover this in Module 03 of the program.