In-Depth With LMK

Trial By Fire: A TMF Training Case Study

How LMK’s TMF University inspired one new hire to overcome her trial by fire and become part of a new generation of TMF professionals. The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of clinical…

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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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