Publish date: Oct 1, 2006By:
Jozef ærts
Source: Applied Clinical Trials
Very recently, the Clinical Data Interchange Standards Consortium, also known as CDISC, released version 1.3 of its Operational
Data Model (ODM). With this new version of the standard, the CDISC ODM team has been able to realize a good number of enhancements
and new features. These new features allow the use of ODM for many more purposes than originally envisaged by CDISC when developing
the first version of the ODM (i.e., the standardized exchange of clinical data).
The CDISC ODM 
Figure 1. An eCRF automatically created for use on a PDA, in French. The ODM standard enables automatic generation of eCRFs
in different languages.
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The CDISC ODM is a data exchange standard for describing study metadata, administration data, and collected clinical data.
Its audit trail system is fully 21 CFR 11 compliant. Extensions to the ODM are and will be used as carriers of information
from protocol description to submission of metadata and data to the FDA. As such, the CDISC ODM and its extensions can be
regarded as the end-to-end solution in clinical data management.
ODM use in EDC
Figure 2. The corresponding eCRF translated into the German language, deployed in a browser application.
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One of the implications of the new version is that it becomes very interesting to use in EDC. For example, if the study metadata
are defined and described in ODM format, then eCRFs (and also paper CRFs) can be created automatically and on the fly from
the study description. To make this possible, the ODM team strongly improved the support for internationalization in the standard;
whereas in version 1.2 translations could only be provided for the questions in the forms, in the new version a set of descriptions
in different languages can be provided at each level of the study design. This allows automatic generation of labels in the
desired language on the paper or electronic form. For example, with one click of the button all necessary forms in the French
language can be generated, and with a second click all the corresponding German forms (Figures 1 and 2).
Figure 3. When the user indicates that the patient is a nonsmoker (3A), all subsequent questions about smoking habits are
automatically blanked out (3B).
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The second EDC-related major improvement is the ability to define conditions under which a visit must not be executed, a form
or item group must not be used, or an item must not be collected. The conditions can as well be defined in human readable
format (multilingual) for use on paper forms, as in machine readable forms. A typical example of such a condition is not collecting
data about pregnancy if the subject is male. Another example is not having a subject answer questions about smoking habits
if in a previous question it has been confirmed that he/she is a nonsmoker (Figure 3).
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