While it is clear that printed case report forms are going the way of the dinosaurs [PDF link], there in a debate going on: What should the replacement technology be called?
EDC Today had an interesting article on this topic, noting that the "terms EDC and eCRF seem to be used interchangeably in the clinical workspace".
A couple of years ago, T. J. Kuhn pointed out that:
What many people are calling eDC is actually eCRF (electonic Case Report Form). A CRF is the standardized form on which the Clinical site (Lay People can think doctor’s office) transcribes relevant data from the medical chart (also called the source) of a clinical trial subject. This form is sent to the sponsor (typically a pharmaceutical company) who enters this data into a computer system and analyzes it to see if their treatment is safe and effective. The distinction is an important one but in the end, it seems like EDC is winning out as a catch-all phrase. (At least according to Google, where edc clinical beats out ecrf clinical and similar search terms.)
An eCRF is an electronic form that does the same thing. The clinical site types the data into an electronic form that gets electronically submitted to the sponsor. Essentially, the sponsor is removing a (paper based) step and pushing the data entry from their internal (Data Management) group to the clinical site. That's eCRF.
From a medical translation perspective, it matters less what you call it and more that it is electronic. As clinical trials expand all over the world, a properly internationalized and localized EDC application will provide for faster and less expensive translations.
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Categories: clinical research