An electronic Trial Master File (eTMF) provides advantages over the traditional paper TMF model that is still commonly used in Europe. An eTMF allows documents to be centralized in one electronic location that can be accessed from anywhere at any time, providing visibility, backup protection, and reducing duplication. However, implementing an effective eTMF requires changes to workflows and consideration of all documentation sources and stakeholders to maximize the benefits of process enhancements and improved data security that an eTMF can provide.