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  • How to Test an IRT: A Primer for Users, Part I

    Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to be substandard means (see, e.g., 21CFRPart11, EU Annex 11, etc) Veracity Logic is an exclusive IRT (IWR/IVR) vendor, so let’s get into the nitty-gritty of what this means for IRT systems. +