Define.xml

CDISC Define-XML for SDTM / ADaM — generated from study metadata and dataset specs in the study tree, not freehand XML. Shell lock (Mock Shells) and Tracker statuses stay separate.

Package & standards ONC-204-301

Package

SDTM ADaM Both

Define-XML version Study OID / ID

Output name

Sources (study tree)

Datasets come from Files folders; specs/aCRF are optional refs for metadata enrichment.

SDTM datasets

ONC-204-301/sdtm/

6 datasets

ADaM datasets

ONC-204-301/adam/

5 datasets

aCRF (optional)

ONC-204-301/docs/acrf.pdf

Linked

Dataset specs (optional)

ONC-204-301/docs/specs/

3 files

Generate & review Idle

Included

6 domains

Standard

Define-XML 2.0

Package

SDTM

Human review gate Needs review

Generation is assisted from metadata + specs. Lock / approve before any publish path. This does not change Mock Shells lock or Tracker checkout/QC.

Stub preview

Domain / dataset catalog

6 selected

	Domain	Class	Source	Label	Spec	Status

Package contents Stub view

OID	Name	Repeating	Structure	Keys

Value-level metadata stubs derived from selected domains (demo).

Dataset	Variable	Where	Data type	Codelist
LB	LBORRES	LBTESTCD = ALT	text	—
LB	LBORRES	LBTESTCD = AST	text	—
ADLB	AVAL	PARAMCD = ALT	float	—
ADAE	AESEV	—	text	CL.AESEV

OID	Name	NCI / C-code	Items (stub)
CL.SEX	Sex	C66731	F, M, U
CL.AESEV	Severity / Intensity	C66769	MILD, MODERATE, SEVERE
CL.NY	No Yes Response	C66742	N, Y
CL.ARM	Description of Planned Arm	—	Placebo, Drug X 100mg

Recent Define packages

Name	Package	Version	Generated	By	Review
define-sdtm.xml	SDTM	2.0	28 Aug 2026 · 3:05 PM ET	M. Chen	Approved
define-adam.xml	ADaM	2.0	12 Aug 2026 · 11:20 AM ET	J. Patel	In review