FOCUS AREAS

PROC CDISC

Base SAS

CDISC Procedure for the CDISC SDTM 3.1 Format

Overview

Support for CDISC SDTM 3.1 data validation is a recent feature addition to the CDISC procedure. PROC CDISC now provides data content checking against the domain definitions provided by the SDTM. This document explains how to use PROC CDISC for CDISC SDTM.

Previously, PROC CDISC supported only the CDISC ODM 1.2 format. For complete PROC CDISC usage and syntax documentation for CDISC ODM, see CDISC Procedure for CDISC ODM 1.2 Format (PDF).

Understanding the SDTM Standard

Whereas the ODM standard defines both a data model and its expression mechanism via XML, the Study Data Tabulation Model (SDTM) is a data content only standard.

The SDTM defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The SDTM was prepared by the CDISC Submission Data Standards (SDS) Team to guide the organization, structure, and format of tabulation data sets for study data submitted to regulatory authorities. Data tabulation data sets are one of four ways to represent the human subject Case Report Tabulation (CRT) and equivalent animal data submitted to the FDA.

The SDTM is composed of 23 defined domains within six broad categories. The model also provides the ability to create custom-defined domains with sets of standard variable definitions. Variables in common across domains all have similar name extensions, and the standard specifies the beginning prefix of all variables be a (typically) two-letter domain abbreviation.

PROC CDISC for SDTM 3.1 Format

Syntax

The PROC CDISC syntax for CDISC SDTM is presented below. The DATA= parameter specifies the location of your SDTM conforming data source.

PROC CDISC        MODEL=SDTM
                  ;

SDTM              SDTMVersion = "3.1"
                  ;

DOMAINDATA        DATA = results.AE
                  DOMAIN = AE
                   CATEGORY = EVENTS
                  ;
RUN;

Supported SDTM 3.1 Domains

The CDISC procedure currently supports 15 of the 23 SDTM domains. The Trial Design Components comprise the majority of unsupported remainder of the list. Values for the domain and category parameters are taken from the table as depicted below:

Supported SDTM 3.1 Domains DOMAIN= CATEGORY=
Demography DM Special
Comments CO Special
Concomitant Medications CM Interventions
Exposure EX Interventions
Substance Use SU Interventions
Adverse Events AE Events
Disposition DS Events
Medical History MH Events
ECG Test Results EG Findings
Inclusion/Exclusion Exception IE Findings
Laboratory Test Results LB Findings
Physical Examinations PE Findings
Questionnaires QS Findings
Subject Characteristics SC Findings
Vital Signs VS Findings

CDISC Procedure Capabilities

PROC CDISC performs the following checks on domain content of the source: The procedure also performs the following checks on domain data content of the source on a per observation basis: With the exception of yes/no and yes/no/null content just noted, the current procedure implementation does not validate the content of controlled terminology responses against a list of acceptable values. An update planned later this year will provide a mechanism for "reversing an assigned format," but currently only the absence/presence of a format is used as the conformance indicator for controlled terminology field content.

Implementation Notes