CDISC SDTM Procedure

DOMAINDATA Statement

Identifies the SAS data set to be validated.

Requirement:	Required.
Examples:	Validating CDISC SDTM Data in a SAS Data Set Validating CDISC SDTM Data in an Oracle Table

Syntax

Required Arguments

Syntax

DOMAINDATA DATA=libref.member-name DOMAIN=domain CATEGORY=category;

Required Arguments

DATA=libref.member-name

specifies the SAS data set that conforms to CDISC SDTM. A SAS data set is any file that is accessed by SAS, such as a SAS data file or a file that points to data from other sources, such as a DBMS table that is accessed with a SAS/ACCESS engine.

The libref, which is assigned with the LIBNAME statement, is an alias for the data storage location where member-name is stored.

Requirement

Required.

DOMAIN=domain

specifies a unique two-character domain code. Each domain is a collection of observations that are common to a specific subject. PROC CDISC currently supports 15 of the domains in CDISC SDTM version 3.1. The trial design components category includes the majority of unsupported domains.

The following table lists the codes for the supported domains:

CDISC SDTM Domains Supported by PROC CDISC
Supported CDISC SDTM Domain	Code
Demography	DM
Comments	CO
Concomitant Medications	CM
Exposure	EX
Substance Use	SU
Adverse Events	AE
Disposition	DS
Medical History	MH
ECG Test Results	EG
Inclusion/Exclusion Exception	IE
Laboratory Test Results	LB
Physical Examinations	PE
Questionnaires	QS
Subject Characteristics	SC
Vital Signs	VS

Requirement

Required.

CATEGORY=model-type

specifies a domain model type. Each model type represents a category from which a domain is derived.

The following table lists the supported model types:

Domain	Model Type
Demography	Special
Comments	Special
Concomitant Medications	Interventions
Exposure	Interventions
Substance Use	Interventions
Adverse Events	Events
Disposition	Events
Medical History	Events
ECG Test Results	Findings
Inclusion/Exclusion Exception	Findings
Laboratory Test Results	Findings
Physical Examinations	Findings
Questionnaires	Findings
Subject Characteristics	Findings
Vital Signs	Findings

Requirement

Required.