How To Use CareLex.

Organize Clinical Trial electronic content

How To Use CareLex

Organizing Electronic Content With Interoperable Content Models

Just as you would use a filing plan to organize paper documents, CareLex™  provides an electronic filing plan to organize electronic documents and content.  This electronic filing plan is called a content model.

CareLex content models are organized by domains.  In this release of CareLex we have published a standards-based content model for the BioPharma electronic Trial Master File (eTMF) domain area.  The CareLex eTMF content model (also referred to as the eTMF Reference Model) is based on content classification terms developed by members of the Drug Industry Association (DIA) Communty’s TMF Reference model.

The CareLex eTMF Reference model incorporates a controlled vocabulary published by the National Cancer Institute’s NCI Thesaurus.   Both the NCI Thesaurus and the CareLex eTMF Reference model are published at the National Center for Biomedical Computing’s National Center for BioOntology (NCBO) BioPortal website.   CareLex content models are freely editable and may be integrated and deployed with any document management system,  application or operating system.   Information on how to download the CareLex ontology for use in your application is also available at NCBO BioPortal.   The CareLex eTMF content model may be accessed at the NCBO BioPortal website at:  http://purl.bioontology.org/ontology/CareLex/   

NCBO BioPortal offers users an opportunity for collaborative use and feedback by users in the life sciences and healthcare communities. Many well known organizations, including WHO, NIH/NCI, MedDRA, and others use BioPortal to publish vocabularies. By publishing on BioPortal, CareLex enables an online dynamic association with terms in the NCI thesaurus and other term databases in addition to collaborative feedback from users.

Example:  Viewing and Searching for eTMF Classifications and Metadata Terms on NCBO BioPortal

Figure 1 below shows a snapshot for the CareLex online ontology database for the eTMF domain. Users can view or download the eTMF ontology database through the NCBO BioPortal website.   Users can browse the CareLex content classification categories, metadata, and term definitions.  Each term has a published URL as well as a unique code to identify the term.   For example, figure 1 shows the eTMF content model hierarchy is expanded and the Protocol classification category is selected. Upon clicking on a category, the category’s relevant definitions or ‘annotations’ are displayed.   The clicked Trial Management Category display a number of annotation properties, including the term preferred name, ID, Full ID, Abbreviation, Term Source URL, Category Code, etc.

CareLex Classification Ontology

Figure 1: CareLex eTMF Classification Ontology – Viewing Content Classification Categories in NCBO BioPortal

 

CareLex Classification Ontology Metadata

Figure 2:  CareLex eTMF Classification Ontology – Viewing a Category and its Metadata

In Figure 2 above, the classification category Protocol is selected.  To the right of the classification category in the annotation properties area we can view the metadata or Data Properties for the Protocol category.    Data Properties divide metadata terms into Core Metadata (i.e., used for any content model, such as Content Identifier, Created, and Organization Name), Business Process metadata and eTMF Metadata (i.e., metadata specific to the eTMF domain area, such as Site ID and Credential).

Community Feedback and Voting on CareLex Content Models and Terms

In the spirit of maintaining an open community, CareLex.org members are encouraged to provide comments on CareLex content models and terms.  The Blog section of the site as well as other areas of the site have been enabled for comments that have a user voting feature.  To vote on a comment up or down, simply press the up or down arrow.

New terms and content models can be suggested for inclusion in CareLex by going to the CareLex site and selecting the contact tab and selecting Suggest New Content Model or Suggest New Term. New content models and new term submissions will be posted for public review and comment prior to formal publication in the CareLex ontology.

Alternatively, if desired, you may submit a review or comments on any ontololgy through the BioPortal website (in the Reviews section) provided in the following URL: http://purl.bioontology.org/ontology/CareLex.

 

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