Pipeline as Code: Automating the SDTM-to-ADaM-to-TLF Chain
How to turn the SDTM-to-ADaM-to-TLF chain into pipeline as code: explicit dependencies, pinned environments, hash-verified outputs, and stage-level failure isolation.
Topic
#sdtm
8 posts
▶ video
From SDTM to Submission: The Clinical Data Flow, End to End
One map of every dataset, standard, and hand-off between the clinic and the regulator — SDTM, ADaM, define.xml, TLFs, and the submission package — and where R now sits at each stage.
SDTM AE Domain Mapping: A Worked Example from Raw EDC Data
A worked SDTM AE domain mapping example: MedDRA coding, serious flags, partial ISO dates, AESEQ derivation, SUPPAE, and CORE validation triage from a mock raw extract.
How to Write an SDTM Mapping Specification (Walkthrough)
How to write an SDTM mapping specification: column anatomy, a row-by-row VS domain walk, hygiene rules, and how specs become define-XML and machine-usable code.
SDTM Domain Basics: The Model Every Clinical Programmer Must Know
SDTM domains explained: domain classes, the topic-timing-qualifier variable pattern, USUBJID, controlled terminology, SUPPQUAL, and a day-one reading order.
CDISC CORE Explained: Open-Source Validation for SDTM/ADaM Programmers
CDISC CORE is a free, open-source rule engine for SDTM and ADaM validation. How its YAML rules work, how to run it, and where rule-based checking stops.
One Number That Explains Where Rule-Based Validation Stops
69.7% of oncology CORE rules port cleanly to a graph constraint language. The 30% that don't are exactly where the dangerous errors live.
The Contradictions Your Validator Can't See
Rule-based SDTM validators structurally miss cross-domain contradictions. SHACL-SPARQL graph constraints plus a deterministic agent layer catch all 20 archetypes.