Many organizations in the health science industry – BioPharma and Healthcare – use Enterprise Content Management (ECM) applications to archive clinical trial documents and document information. Although many organizations organize and share the same documents, they lack a common vocabulary and a common technology that can be used to classify, organize and exchange electronic content.
For large enterprises with multiple electronic content repositories, it is difficult to efficiently search, report, and audit sets of documents and their associated records without a common set of vocabulary terms. For example, if an organization wishes to search for a set of documents from the country ‘France’, unless each document is tagged with the term ‘Country’, it would be very difficult to find the set of documents in a large enterprise. Hence, information is difficult to locate unless it is indexed with a common published set of vocabulary or metadata terms.
This lack of interoperability among digital content repository resources, due to vocabulary and schema differences, makes rapid secure information discovery, retrieval, exchange, and sharing difficult for organizations. While efforts are moving forward in areas such as HL7 on broader information exchange issues, these initiatives do not address how electronic document information should be automatically classified, tagged and archived for higher efficiency.
Central to our vision is the belief that organizations who create electronic document repositories should have the flexibility to classify, name, and organize documents in a way that meets their business needs and yet have interoperability, i.e., the ability to rapidly search and share repository resource information with others.
CareLex™ seeks to address the electronic archive interoperability issue with a three layered approach: One – Use of standards-based published vocabularies or terms, Two – Use a published, machine-readable content classification layer that is freely available, Three – Use internet standards for information classification and exchange. By using a standards-based, machine readable model, enterprises are able to facilitate automated information exchange and can automate manual document classification processes. Unlike paper-based classification systems, the CareLex content classification model has been designed from the outset to deliver the benefits of electronic automation for seamless information sharing, storage and retrieval.
CareLex’s initial content model for the BioPharma clinical trial area uses published vocabularies developed and used by leading health science organizations, such as the National Cancer Institute, HL7, CDISC, FDA and other industry resources. CareLex is published as an open community, web-based project that addresses industry-wide content repository resource exchange and incompatibility issues. CareLex’s web based term collaboration effort is open and freely available to anyone worldwide.
The CareLex electronic content classification model, the CareLex terms database, as well as any CareLex publications on CareLex.org can be freely used under the terms of the Apache 2.0 license.
Further information about using CareLex in your organization is available at www.CareLex.org/publications.
CareLex™ is a trademark of CareLex, a non-profit organization