10 CDISC ODM Representation in OpenClinica

The Clinical Data Interchange Standards Consortium (CDISC) is a clinical research standards body formed to encourage maximum sharing of information and minimum duplication of efforts.  One of the standards CDISC has created and endorsed is the Operational Data Model (ODM), which facilitates the archive and interchange of the metadata and data for clinical research. ODM is represented in XML format and is designed to collect data from many different sources into one document.

Purpose of this document

OpenClinica provides and/or consumes CDISC ODM XML representations in its Extract Data and Import Data modules and other parts of the software. This document describes how OpenClinica represents study metadata and data that is stored in its internal database as CDISC ODM XML documents. It assumes a working knowledge of CDISC ODM 1.3 and of OpenClinica, and attempts to describe how each OpenClinica field or element is represented in ODM, and under what conditions. The document is best read when accompanied by the CDISC ODM standard. It is geared towards developers, but is also intended for data managers who want to know more about the capabilities of ODM XML export in OpenClinica. Additionally, parts of this document will find its way into the online documentation, for all end users.

OpenClinica’s ODM representation has changed iteratively from version to version of OpenClinica, and the appendix to this document charts these changes since version 2.5 and the addition of the custom extension to the ODM, introduced with OpenClinica 3.0.

Scope of this document

This document provides a detailed specification of the OpenClinica CDISC ODM XML version 1.3 with OpenClinica Extensions as implemented in the OpenClinica 3.1 and later releases.

Definitions and acronyms

Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2014-10-11 2:07PM

Not valid unless obtained from the OpenClinica document management system on the day of use.