Clinical · Evidence
Every CDISC standard this site produces or reads: the version it is pinned to, the newest version CDISC publishes, and each check that holds the site to the pin, with what that check found.
A demonstration, not a validated or certified system. All data is synthetic. CDISC has not reviewed or endorsed this site; the CDISC CORE results are what the open-source engine reported on this site's files.
From the shape of a file up to the site's own rules. Results are from CDISC CORE v0.17.1 at commit 2a90a387, recorded in CI and refreshed by a documented procedure.
Layer 1
A file that does not match its schema cannot be merged, so every schema check on the main branch passes.
Layer 2
CORE checked the datasets against its newest cached terminology, 2026-03-27; the datasets cite 2026-09-25.
Layer 3
Counts are for the default run. Each failing rule's findings carry a recorded reason: by design, a CORE limitation, or a tracked defect.
Layer 4
The SDTMIG rules above that cite an FDA rule id. They are part of the same run, not a separate validation.
Layer 5
Not evaluated
FDA rules that CORE does not implement are not run. A submission would need a validator that covers them.
Layer 6
Counts are for the DEMO-301 study design.
Layer 7
Unsupported
CDISC CORE publishes no ADaMIG rules yet, so the ADaM datasets are checked only by the site's own AD rules below.
Layer 8
Evaluated per run
75 SD rules and 18 AD rules. Tests plant each of the 16 scenario defects and require a rule to catch it. Where CORE catches the same defect, the rule names its CORE twin.
A weekly job reads the newest published versions from CDISC's own pages and repositories. A newer version is recorded, never adopted automatically: moving a pin is a separate, reviewed upgrade.
CRF Studio authors, imports and exports one study design per study: population, eligibility, objectives and endpoints, interventions, arms, epochs, encounters and activities. The Study Data Pipeline reads the DEMO-301 design.
author, import, export, validate
CRF Studio's 13 CDASH domain templates: variable names, core designations and data types. No CDASH conformance rules are run.
author (subset), export
The model variables the generated SDTMIG domains use.
generate
SDTMIG 3.4, the newest SDTMIG, is built on SDTM 2.0. CDISC lists the newer SDTM with the Tobacco Implementation Guide.
Domains DM, AE, CM, DS, EG, EX, IE, LB, MH, SV, VS and SUPPDM, and trial design TA, TE, TI, TS and TV. SEND, SDTMIG-MD and SDTMIG-AP are not covered.
generate (subset), export, validate (subset)
The model principles the generated ADaMIG datasets follow.
generate
ADSL; BDS datasets ADVS, ADLB and ADEG; ADTTE. Checked by the site's own AD rules only, because CORE publishes no ADaMIG rules.
generate (subset), validate (subset)
Run through CDISC CORE's executable rules and the site's own SD rules. A published rule CORE does not implement is not run.
validate (subset)
ADAE and ADCM, checked by the site's own AD rules.
generate, validate (subset)
Partly, through the site's own AD rules. The published catalog is not implemented.
validate (subset)
One Define-XML per run, validated against the schema and checked for parity with the datasets. The published Define-XML conformance rules are not run.
generate, validate
Every SDTM and ADaM dataset. XPT and CSV downloads are file formats, not a conformance claim.
export, validate
One reporting event per run. Result lineage is written to a separate file, not into ARS.
generate, validate
CRF Studio forms, items, codelists and study events as ODM metadata at the pinned version. No clinical data.
import (subset), export (subset), validate
Define-XML 2.1 extends ODM 1.3.2, so CRF Studio exports the ODM version the site's Define-XML and most EDC imports use.
SDTM Terminology
ADaM Terminology
DDF Terminology
CDISC Open Rules Engine (CORE)