CareLex and CareLex eTMF Reference Model FAQ

CareLex’s technologies are open source, standards based technologies designed to promote the interoperable exchange of clinical trial electronic documents, email and medical images.  In order to facilitate  interoperability in clinical trial content exchange, CareLex adopted the industry terms used in the TMF Reference Model for the CareLex™ eTMF Reference Model.

The substantive difference between the CareLex eTMF Reference Model and the TMF Reference Model involves technology and standards-based terms.  Under the CareLex eTMF RM, paper content classification is supported just as it is under the TMF RM.  However, although it supports paper, the CareLex eTMF RM was designed from the beginning to support 100% digital content repositories based on technology and a standards-based ‘controlled vocabulary.’

CareLex converted the TMF Reference Model from a human readable spreadsheet into a machine readable format suitable for use in computer systems and databases.  In order to complete this work, CareLex integrated and electronically linked its model to published controlled vocabularies from the National Cancer Institute’s NCI Thesaurus, HL7 and other published sources to create a standards-based, controlled vocabulary for use in clinical trial content exchange and standards-based metadata tagging.

In order to enable clinical trial content exchange between systems and applications, the CareLex eTMF RM includes a core set of required eTMF terms and standards-based metadata.  All of the core CareLex eTMF classification terms map to TMF RM terms, so its easy to migrate from paper-based systems to an 100% digital eTMF content repository.

To automate clinical trial processes and to eliminate the need for paper, the CareLex eTMF RM incorporates support for business process automation as well as digital certificate signing.  CareLex eTMF RM metadata supports auditing and tracking of all content in the eTMF repository.

Combined, the CareLex eTMF Reference Model utilizes the collective best of the TMF Reference Model, industry standard technology and terminology to enable electronic global exchange of clinical trial documents across the BioPharma industry.

The machine readable CareLex eTMF Reference Model is freely downloadable for internal company use without any fee.   The CareLex eTMF Reference Model is published at the National Center for BioOntology’s BioPortal website.  The CareLex specification can be freely downloaded in the downloads section of CareLex.org.

Q&A

Q1:  Is the CareLex™ eTMF Reference Model the same as the TMF Reference Model (TMF RM)?

While the CareLex eTMF Reference Model adopts most of the industry terms that are used in the CareLex Reference model, the two have differences as follows:

CareLex™ eTMF Reference Model (CareLex eTMF RM)

  • Developed to support eTMF content classification for digital documents, email, medical imaging.  Supports hybrid systems requiring paper and digital documents
  • Contains approximately 300 filing plan industry classification terms used in the TMF Reference model
  • Metadata terms are sourced from published controlled vocabularies:  NCI Thesaurus, HL7
  • CareLex eTMF terms are mapped to TMF RM terms
  • Some TMF RM terms were refactored to support machine readability and use in databases
  • Support for digital document signing to eliminate the need for paper
  • Standard core classification model enables electronic data exchange between cloud apps and systems
  • Standards-based data exchange format (XML based)
  • Independently developed and tested on clinical trials over a 2+ year period
  • Open source and freely downloadable – published at the National Center for BioOntology’s BioPortal site.

TMF Reference Model

  • Initially developed primarily for classification of paper-based Trial Master Files
  • Contains approximately 300 filing plan industry classification terms
  • The core TMF RM Filing plan is often modified and customized by companies, resulting in an inability to electronically share information between systems
  • Works well for organizations who are paper-centric and don’t need to exchange data between systems.

Q2:  How does the CareLex eTMF Reference Model and database and data exchange model differ from the TMF Reference Model?

The TMF RM doesn’t have machine readability since it’s a human readable spreadsheet.  Therefore, the TMF RM model cannot be shared between computer applications without investing in programming or integration services.  The CareLex eTMF model was designed to be machine readable based on web standards, meaning that its easily imported into existing software applications and can be shared without custom programming.  The CareLex eTMF model can be edited in open source editing tools and the saved file can easily be imported into a study as the design for the eTMF database or filing plan.

 

Q3:  Can organizations who have implemented the TMF Reference Model migrate to the CareLex eTMF Reference model?

Since the CareLex eTMF RM classifications map to TMF RM classifications, it is possible to migrate existing study data that was classified, stored or archived using the TMF RM to the CareLex eTMF RM model.  At this time CareLex is working on the development of a migration tool that would enable automated migration of TMF RM information models to a machine readable CareLex eTMF RM model.  The TMF RM migration tool will be made freely available to CareLex members.

Q4:  How will you engage industry, research organizations and other non-profits in the development, and maintenance of the CareLex eTMF Reference Model?

CareLex will continue to be a sponsor of the eTMF standards initiative and seeks to help facilitate development, publication and maintenance of an eTMF standard with support and feedback from industry, academic research organizations and other non-profit organizations who support BioInformatics research and development

Q5:  How can I get involved with CareLex?

We are in the process of seeking partnerships with organizations who value the important productivity and cost savings that an eTMF standard can provide.   If you are a non-profit, industry group or corporation who is interested in learning more, please contact us at admin@CareLex.org

Technical

Q6:  Why are you using the RDF/XML syntax for content models?  Why not just use XML?

Answer:    In order to link to a wider number of existing standards based terms published by Healthscience standards bodies, CareLex was published using the RDF/XML format.  A large number of Life Science and healthcare vocabularies and terms are published on NCBO’s BioPortal use the RDF/XML format:   NCI Thesaurus, MedDRA, ICD-10 and many more share use of the RDF/XML ontology format.  RDF/XML is discoverable, is machine readable in online or offline modes, and is a W3C web standard which enables global information sharing.    RDF/XML supports direct import of content models into Content Management systems and databases.

Q7:  Most Enterprise Content Management systems support CMIS for exchange of content.  Why can’t we just use CMIS as a way to exchange content between content management systems?

Answer:  While CMIS is an excellent step forward toward facilitating content exchange between online systems, it requires custom programming and development to exchange content.  The goal with the CareLex eTMF data exchange format is to enable online or offline exchange of content without requiring any integration or programming.

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