ODMv2: Renovating the ODM Standard

ODM, CDISC's Operational Data Model, version 1.x will be 17 years old in October, making it a mature standard. ODM has come of age, and it's time for ODM to take on a bit more responsibility around here. Toward this end, a new XML Technologies development team has recently started work on ODMv2, a substantially updated version of ODM that breaks backwards compatibility with version 1.3.x to add a number of significant new features. This post highlights some areas of new development for ODMv2. As ODMv2 is still in the early stages of development, the scope of the project and specific features are subject to change.
Among the more important new ODMv2 features will be a RESTful API that specifies standard methods of data and metadata exchange. The RESTful architecture uses specific URLs and the HTTP protocol to leverage pervasive, scalable web technologies to simplify data interchange. Lack of a common API for data exchange in clinical research has limited the available interoper…

Loading Terminology in SHARE: What's the DIFFerence?

We load the CDISC Controlled Terminology (CT) published by the NCI Enterprise Vocabulary Services (EVS) into the SHARE metadata repository (MDR). When we're through catching up with our backlog we'll have more CT in SHARE than any other type of metadata, and we'll publish the quarterly CT content to the SHARE Exports page on the CDISC web site. One of the main differences in how we load the CT is that we load only the incremental changes. That is, we load the differences by generating diff files that contain only the changes between the packages published in the current quarter and those published in the previous quarter. The diff files are available for download, or they can be generated using the NCI's Diff program. This program is a Java application, and it is simple to set up on most machines.

The Diff application is easy to use and can generate diff files for any two versions of a delimited text CT package. The two packages used to generate the diff file do not ne…

Define-XML v2.1 – What do you think?

If you're wondering where the XML standards like Define-XML went on the CDISC website, they've moved. They're now located under Standards/Transport. If you go to the transport page you can select from a fairly extensive menu of transport standards. There are a few transport options located elsewhere, such as Lab and the Analysis Results Metadata Define-XML extension.

Our broad list of XML standards is in the process of welcoming a new version of Define-XML to the family. This new version of Define-XML, v2.1, will almost certainly be listed in the standards catalogs of regulatory authorities at some point, so all of you working on regulatory submissions should find this update interesting. There are a couple weeks left in the Public Review period (it ends on May 5th) so there's still time to add your comments. You can find the Define-XML v2.1 Public Review package along with instruction for adding JIRA comments on the CDISC wiki.

While Define-XML v2.1 is a minor point r…

Using the SHARE API to Grab the Latest CDISC Terminology Packages

Keeping your repository up to date with the latest CDISC Controlled Terminology (CT) packages represents a challenge to many organizations. The SHARE API make it easier to retrieve the CT packages and initiate the process of updating your repository. In this post I'll walk through the process of finding and retrieving the CT from SHARE using the API. We'll use the default media type of XML. When requesting a full CT package the XML media-type uses the NCI EVS extended versionof ODM that includes the additional metadata needed to represent the CT content.
The following figure provides an overview of the steps taken to retrieve the latest CT packages using the SHARE API. The first step is to determine what CT Packages are available for loading. This can be done by using the Get Standard Terminology List API. The SHARE API is RESTful so this entails requesting the /terminology-packages resource. The default Lifecycle-Status parameter retrieves Approved Final content. Since the N…