From Paper to Pixels: The Rise of eTMF Systems in Clinical Trials
Electronic Trial Master Files (eTMFs) have become a fundamental component in modern clinical trial management, revolutionizing how documentation and data are handled. The transition from traditional paper-based Trial Master Files (TMFs) to eTMFs presents both significant benefits and challenges that are reshaping the landscape of clinical research. Advantages and Evolution of eTMFs eTMFs offer several…
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The Framework for TMF Success: People, Process, and Technology
For years, LMK Clinical Research Consulting has described the TMF in terms of an operational framework of people, process, and technology. These three elements, known by many as the TMF Trifecta, represent the real-time interplay among TMF stakeholders, the actions those stakeholders take, and the technology necessary for them to carry out their role successfully…
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How To: Determine on Which TMF Level a Document Should Be Filed
As discussed in our recent newsletter entry, How To: Use the TMF Reference Model, the TMF Reference Model is an industry-adopted index that has increased TMF quality and ease of use. We used columns A through H of the TMF Reference Model to correctly file a document by determining its Zone, Section, and Artifact. Now…
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How To: Use the TMF Reference Model
The TMF Reference Model is an industry-adopted reference TMF structure that takes the form of an index. Think of the TMF Reference Model like the taxonomy that biologists use to classify all the various types of life on Earth. Or consider another familiar index, the Dewey Decimal System which helps keep books organized in a…
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Understanding the Humans of the TMF
Evaluating TMF stakeholder attitudes to achieve inspection readiness. Any solution to the problem of TMF inspection readiness must consider more than just the hardware and software of the eTMF, but must also consider how electronic tools augment the human roles, processes, and relationships that author the narrative within each TMF. This whitepaper, utilizing original survey…
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How to Apply the Golden Rule of Research to Your Trial Master File
The Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is essential to the overall health and stability of any clinical trial. The Golden Rule in clinical research (which also applies to the TMF) is, “If it’s not written down, it didn’t happen.” Click here to read the White…
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