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| CDISC Procedure for CDISC SDTM |
DOMAINDATA Statement
Identifies the SAS data set to be validated.
| Requirement: | Required. |
| DOMAINDATA DATA=libref.member-name DOMAIN=domain CATEGORY=category; |
| Arguments |
- DATA=libref.member-name
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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-code
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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 include the majority of unsupported domains.
Requirement: Required. 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 - CATEGORY=model-type
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specifies a domain model type. Each model type represents a category from which a domain is derived.
Requirement: Required. The following table lists the supported model types:
CDISC SDTM Domain 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
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