Question 4 of 6 Intermediate Scenario
How do CDASH and SDTM serve different stages of a study?
Short answer
CDASH standardizes the way clinical information is collected. SDTM standardizes how collected and received information is organized for tabulation and regulatory review. They are linked but not identical.
Why
A site records blood pressure, collection date and method in an electronic form designed with CDASH principles so questions and codes are consistently understood. A mapping process then creates SDTM domains with specified variables, terminology and metadata for review and submission. The transformation should preserve the original meaning and traceability to source fields.
A collection form need not mirror the SDTM domain layout exactly, and SDTM is not itself an analysis-ready dataset. ADaM can support traceable statistical analysis downstream where applicable. Data mapping requires review for timing, units, missingness and unscheduled observations.
Use the versions accepted for the applicable study and authority: as of October 2026, CDASH model v2.0 and SDTM v3.0 are still in development rather than universally implemented releases.
Common mistakes
- Saying that CDASH is simply SDTM with different column names, or that a draft version is already mandatory
The interviewer might ask next
Where would ADaM fit in a path from an eCRF field to a primary endpoint analysis?