CareLex Specifications and Publications


After extensive testing and development, CareLex has released the CareLex Specification and supporting technologies for BioPharma content classification.  The specification and technologies should be used as guidance in developing interoperable content classification models for use in the BioPharma or Healthcare areas.

In order to facilitate the interoperable exchange of clinical trial master file electronic records, documents and medical images,  CareLex is delivering the following items: 1) CareLex Specification, a proposed standard for electronic content classification in BioPharma Clinical Trials;  2) CareLex Ontology – a machine-readable content classification model database with standards-based metadata for the electronic trial master file (eTMF) domain, and 3) CareLex classification model spreadsheet — a human-readable spreadsheet that describes the CareLex classification categories and metadata definitions.    The CareLex eTMF ontology is best viewed online at the National Center for BioMedical Ontology’s (NCBO) BioPortal website.

CareLex Specification

  • June 27 2013 – CareLex Specification V1.03,PDF format, 1.6MB [wpdm_file id=4]
  • CareLex Spec – V1.02, June 9 2013, PDF format, 1.4MB [wpdm_file id=3]
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