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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

Most things in life are not black and white, and clinical research is no exception. With so many rules to follow and principles to abide by, it’s all too easy to forget that clinical research isn’t immune to grey areas. One of the notable grey areas comes in the form of the investigator site file (ISF). I often hear questions about the ISF and its relation to the trial master file (TMF). Are they equivalent? Do they have the same regulatory requirements? Who’s responsible for ensuring their quality? Unfortunately, the answers to these questions are not straightforward in nature. If you’re wondering whether talking about the ISF means talking about the TMF, the answer is neither yes nor no—the truth exists somewhere in the middle and represents one of the notorious grey areas of understanding around clinical documentation. Why? Well, allow me to explain...


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