Codebase study packs · ClinCoder

Study Packs

Module-anatomy walkthroughs of the ClinCoder codebase, plus standalone teaching packs on the three standards areas that cost the most time to learn properly. Written to be read end to end, not searched.

4
packs, all A4 print-ready PDF
282
pages in total

Codebase series

Volume 1 — SDTM Mapper & SDTM Review
The mapping pipeline read module by module: what each file is for, how the deterministic and LLM routes divide the work, where the gates sit and what they actually prove.
175 pages · 1.4 MB
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Teaching packs

Validation Gates
What a gate is, why it is the only thing that scales autonomous workers, and the rule that a model may write a test but only a run may write an evidence file.
38 pages · 210 KB
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Define-XML
The submission metadata document: structure, the FDA rules that bind it, and the checks that catch a define that will fail review.
36 pages · 206 KB
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Controlled Terminology Mapping
CDISC codelists in practice — why Daily is wrong where QD is right, and how a missing codelist quietly turns a passing pipeline into a non-conformant delivery.
33 pages · 205 KB
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How to read these. The codebase volume assumes you have the repository open beside it — it names real files and real functions, and it is much less useful read cold. The three teaching packs stand alone and can be read in any order.
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Related: Clinical R Packages · R for Clinical Statistical Programming · Endpoint to TLF