CareLex eTMF Content Model Published at National Center for Biomedical Ontology’s BioPortal

At CareLex we continue to see increased adoption of the CareLex eTMF Content Model.  Recently, the eTMF Content Model was published by the U.S. National Centers for Biomedical Computing’s (NCBC) National Center for BioMedical Ontology (NCBO) website, BioPortal.

The CareLex eTMF Content Model is available for anyone to view, download or comment on through the NCBO’s BioPortal.   The goal is to maintain the CareLex eTMF online content model as a permanent online resource for use by industry, vendors and clinical trial stakeholders.

To insure interoperability of clinical trial eTMF content, the CareLex eTMF content model utilizes a controlled vocabulary from the National Cancer Institutes’ (NCI) NCI thesaurus as well as a standards-based ontology. The NCI thesaurus controlled vocabulary is also published at NCBO, using a machine readable ontology. The draft eTMF content model uses the same machine readable ontology as NCI, enabling online references to published NCI terms in the eTMF online content model.

The online CareLex eTMF content model is available for free download from NCBO BioPortal.  The National Center for Biomedical Ontology is one of the National Centers for Biomedical Computing supported by the NHGRI, the NHLBI, and the NIH.

To view the draft eTMF Standard content model, just go to the following link:

For information on how to use the draft eTMF standard to organize electronic documents and content, visit:

The CareLex eTMF content model published at NCBO’s BioPortal has been submitted to OASIS as the candidate for the new eTMF standard.