CareLex Model for BioPharma Content Classification Submitted to Global Agencies

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Electronic Trial Master File (eTMF) Reference Model Proposed as New Standard for Content Classification Interoperability in Clinical Trials

CareLex Content Classification Model

CareLex Reference Model

“With the CareLex standard, clinical trial research organizations can electronically share clinical trial content among globally distributed research teams."
– Zack Schmidt, Executive Director of CareLex.

CareLex, a non-profit public benefit organization for BioInformatics research and development, today announced that it has submitted the CareLex eTMF Reference Model for health sciences content classification to regulatory agencies worldwide, including the FDA in the USA, the European Medicines Agency, the Ministry of Health, Labour and Welfare in Japan and the State Food and Drug Administration in China.

Designed for use in clinical trials for pharmaceutical and medical device research organizations, the CareLex content classification model addresses BioPharma industry electronic content classification and content interoperability issues. The CareLex model uses a standards-based content classification model that allows sharing and exchange of clinical trial digital content among organizations globally.

“As clinical trial stakeholder organizations seek to move from paper-based research to electronic, network driven approaches, information interoperability, information standards and agency compliance are key factors in accelerating the safe delivery of therapies to patients globally,” said Zack Schmidt, Executive Director of CareLex. “With the CareLex Model standard, clinical trial research organizations can electronically share clinical trial content among globally distributed research teams." The CareLex model specification is available for free download at http://www.CareLex.org

The CareLex Reference Model provides an interoperable foundation that all stakeholders in the clinical trial value chain can build upon. By adopting the CareLex Model, clinical trial stakeholder organizations can seamlessly share clinical trial information using a standards-based model to collaboratively raise the effectiveness and efficiency of clinical trials. CareLex is a flexible model that can be adapted to meet organization specific business models, while at the same time offering content exchange interoperability. The CareLex Model is proposed as a guideline for use by stakeholders throughout the clinical trial process who create, manage or exchange clinical trial regulated content.

CareLex Reference Model Features
The CareLex Reference Model for the Electronic Trial Master File (eTMF) domain provides clinical trials stakeholders with the following foundation to build clinical trial information interoperability:

A standards-based foundational architecture consisting of three layers that are available in a machine readable database:

-First - Use of standards-based published vocabularies or terms developed and curated by leading health science organizations, such as the National Cancer Institute, HL7, CDISC, FDA and other industry resources.

-Second - A published, machine-readable content classification layer that is operating system and application independent.

-Third – Adoption of internet standards for information classification and exchange.

In addition to the CareLex standards-based foundation, the CareLex Model includes support for the following:

-Workflow and business process support – the CareLex Model includes support for use of the Business Process Modeling Notation (BPMN) standard

-Audit trail support – Support for record timestamping and audit trail detail capture

-Digital Signature support

-CareLex technologies are freely licensed to any organization under the terms of the Apache 2.0 open source license.

The CareLex Reference Model can be used with any electronic record keeping approach: From simple file system and folder approaches all the way to sophisticated electronic content management systems.

The CareLex Reference Model provides clinical trial stakeholder organizations with an interoperable approach to accelerate information exchange for global clinical trials, reducing paper, enhancing compliance efforts, and improving clinical trial technology collaboration.

The CareLex Model is published online at the US National Center for Biomedical Ontology’s (NCBO) BioPortal website. The CareLex model can be viewed, commented on and downloaded at: http://purl.bioontology.org/ontology/CareLex

About CareLex
CareLex™ is a non-profit public benefit organization for BioInformatics research and development. Organized in 2012 by a core group of clinical trial domain and bioinformatics experts, CareLex provides open source technology for BioPharma content classification and management. CareLex is open to anyone worldwide. For more information, visit http://www.CareLex.org.

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Trademarks
CareLex is a trademark of CareLex

Copyright 2013 CareLex, a non-profit public benefit organization for BioInformatics research and development.

Media Contacts
Zack Schmidt
CareLex
admin(at)CareLex(dot)org

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Zack Schmidt
CareLex
916-265-2000
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