Welcome to eTMF.org
- Last Updated on 17 July 2014
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What is an eTMF? Electronic Trial Master File systems, or eTMFs, are specialized enterprise content management systems that are used to manage clinical trial content.
Many organizations involved in BioPharma clinical trials want to move from paper-based document management systems contained in file cabinets to online electronic document management systems where documents are stored in online electronic archives.Organizations who use electronic content management systems can achieve higher clinical trial productivity, achieve cost savings and shorten clinical trial study timelines.
However, although electronic content management systems can offer an organization operational efficiency, there is no widely accepted and widely adopted standard or 'schema' for the classification, storage or exchange of electronic Trial Master File (eTMF) documents in clinical trial studies. A common schema for eTMF electronic document archives would enable seamless electronic document archive exchange among industry stakeholders.
To enable productivity in eTMF content management area through interoperability, eTMF.org worked with CareLex.org to publish a specification for eTMF content management. The resulting CareLex eTMF Reference model is published at CareLex for use in eTMF content management applications. The specification can be freely used by anyone in the industry. Go to http://www.CareLex.org/publications for more info and to download the spec.
Update - July 2014: