FOCUS AREAS

PROC CDISC

Base SAS

CDISC Basic Concepts

Overview

The Clinical Data Interchange Standards Consortium is a nonprofit organization that provides industry standards for clinical-trial data. The consortium's mission:

"The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare."
(Clinical Data Interchange Standards Consortium 2010)

This document provides basic concepts that are related to the CDISC standards.

Concepts

Analysis Data Model (ADaM)
a file format for data that is related to health care. Note: This model is not supported by the SAS® Clinical Standards Toolkit, SAS® Clinical Data Integration, or the CDISC procedure. However, it is planned that Clinical Data Integration will support the model in the future.

CDISC procedure
a Base SAS® procedure that processes data in the Operational Data Model (ODM) 1.2, Study Data Tabulation Model (SDTM) 3.1 formats. Note: PROC CDISC only supports ODM 1.2 and SDTM 3.1.

SAS® Clinical Standards Toolkit
a collection of macros that processes clinical data and creates the define.xml file for submission to the U.S. Food and Drug Administration (FDA). Note: The Clinical Standards Toolkit does not support ADaM, but it does support ODM 1.3 and SDTM 3.1.1.

SAS® Clinical Data Integration (CDI)
a plug-in module for the SAS® Data Integration platform that processes clinical data and prepares the define.xml file for submission to the FDA. Note: Clinical Data Integration does not support ADaM, but it does support ODM 1.3 and SDTM 3.1.1.

CDISC Operational Data Model (ODM)
a format standard for data (study data and administrative data) that is associated with a clinical trial.

CDISC Study Data Tabulation Model (SDTM)
a model that defines a standard structure for clinical-trial data tabulations for a product prior to the product submission to a regulatory agency such as the FDA.

Define.xml
the final data-submission file that is sent to the FDA. This file is created by the Clinical Standards Toolkit.

Domains
a collection of observations (in both ODM and SDTM) that have a relationship to each other (for example, demographics or adverse events).

Health Level 7 (HL7)
"a messaging standard that enables clinical applications to exchange data.
  • HL7 V2 uses name-value pairs. The SAS DATA step the best way to read in an HL7 file.
  • HL7 V3 uses XML. Therefore, the XML engine currently is the best way to read such files.
JANUS
a clinical-data repository that uses the open-source data model. This repository provides a data-collection and analysis warehouse for clinical-trial data that is submitted for protocols (what was supposed to happen) as well as for clinical-outcomes data (what did happen; for example, events, interventions, and so on).

Resources

Clinical Data Interchange Standards Consortium. Standards. 2010. Available at http://www.cdisc.org/standards.

SAS Institute Inc. SAS CDISC Procedure: User's Guide. Cary, NC: SAS Institute Inc. Available at http://support.sas.com/documentation/cdl/en/cdisc/64992/HTML/default/viewer.htm#titlepage.htm.

Shostak, Jack. 2005. SAS Programming in the Pharmaceutical Industry. Cary, NC: SAS Press.