cm.standards/inventory · 22 standards

CDISC-native.
Sponsor-extensible.

Every output is built on industry standards from the start — not bolted on at submission time. Some standards are live today (used by Protocol Authoring + Study Build); others are scoped for roadmap modules as they ship. Your sponsor extensions layer on top of CDISC either way.

§01 / 03 group: data_standards count: 6 scope: collection → submission

Data standards. End-to-end.

CDASH collection. SDTM tabulation. ADaM analysis. Define.xml metadata. Annotated CRFs. Reviewer guides. Every domain mapped, every variable traced.

standards/data conformance: enforced 6 entries view: live
cm-standards // data_models scope: CDISC extensibility: sponsor libraries tracked
CDASH CDASHClinical Data Acquisition Standards Harmonisation Collection-level CRF standard. Default for new study builds; deviations documented per study. CDASH-IG 2.2 live
SDTM SDTMStudy Data Tabulation Model Submission tabulation. All standard domains (DM, AE, EX, LB, VS, CM, QS, TA/TV/TS, …) plus sponsor extensions. Scoped for §08 (roadmap). SDTM-IG 3.4 roadmap
ADaM ADaMAnalysis Data Model Analysis-ready datasets. ADSL, ADAE, ADLB, ADTTE scaffolds; BDS structure for custom analyses. Scoped for §08 (roadmap). ADaM-IG 1.3 roadmap
DEFINE Define.xmlSubmission metadata package Metadata package for SDTM + ADaM. Auto-generated from the mapping specification. Scoped for §08 (roadmap). Define-XML 2.1 roadmap
USDM USDM 4.0 / DDFUnified Study Definition Model Protocol authoring model. Round-trip exports score ~100/100 on CDISC CORE rules. CORE engine runs as Layer 3 of the pre-export gate. USDM 4.0 (2025-06-03) live
CT NCI / CDISC CTControlled Terminology CT bindings on every Code-typed field. Pinned per study and per environment. CDISC CT 2024-09-27 live
§02 / 03 group: coding_dictionaries count: 4 scope: per-study version-pinned

Coding dictionaries. Version-pinned per study.

Dictionaries themselves are not edited — usage and conventions are. Versions pin per study and per environment to preserve consistency through lock.

standards/coding pinning: per-study 4 entries recode: source-change-triggered
cm-standards // dictionaries auto-coding: ≥0.85 confidence review: <0.85 live
MEDDRA MedDRAMedical Dictionary for Regulatory Activities AE, medical history, optional procedures/tests. LLT → PT → HLT → HLGT → SOC hierarchy. Scoped for §06 (roadmap). MedDRA 27.0 roadmap
WHODRUG WHO Drug GlobalConcomitant medications dictionary Trade-name + active-ingredient resolution with ATC-level coding. Scoped for §06 (roadmap). WHODrug B3 roadmap
SNOMED SNOMED CTClinical terminology (optional) For sponsors who require SNOMED-coded medical history alongside or instead of MedDRA. SNOMED CT 2025-03 optional
LOINC LOINCLaboratory observation identifiers (optional) For cross-lab analyte harmonisation across central + local labs. LOINC 2.78 optional
§03 / 03 group: regulatory_standards count: 6 scope: GxP architecture

Regulatory standards. Architecturally enforced.

The platform's audit, validation, and submission machinery is shaped by these regulations. Compliance isn't a feature — it's the architecture.

standards/regulatory enforcement: foundational 6 entries audit-ready
cm-standards // regulatory FDA · EMA · ICH validation: per-release aligned
21 CFR 21 CFR Part 11FDA · Electronic records and electronic signatures Audit trail, electronic signatures, access controls, validation evidence. The foundation of the GxP architecture. FDA · current live
ANNEX 11 EU Annex 11EU GMP · Computerised systems Risk management, supplier qualification, validation. Sister regulation to 21 CFR Part 11 for EMA-scope studies. EU GMP 2011 live
ICH M11 ICH M11Clinical electronic structured harmonised protocol Directly drives the 84-section M11 generator inside protocol authoring. ICH M11 Step 4 live
ICH E6 ICH E6(R3) GCPGood Clinical Practice Quality management, critical-to-quality factors, ALCOA+ data principles. Mapped to the audit-trail schema. ICH E6(R3) 2025 live
CORE CDISC CORE rulesConformance rules engine Runs as Layer 3 of the pre-export compliance gate. Exports block on ERROR-severity unless overridden with audited reason. cdisc-rules-engine v0.16+ live
PRS / CTR ClinicalTrials.gov + EU CTRPublic registry submissions CT.gov XML and CTIS structured submissions. Same pre-export compliance gate pattern. Scoped for submission flow (roadmap). PRS · EU CTR 2025 roadmap
cm.demo

Bring your own libraries.
We'll layer them on.

Sponsor edit-check libraries, SDTM extension domains, sponsor codelists, authoring templates — all layer on top of CDISC. Your standards inherit from theirs.

Talk to us → or see the platform