Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when undertaking FDA-regulated clinical trials of medical devices.

With that in mind, this article will walk you through the FDA’s guidance and regulations on clinical data management and reporting, as well as what you’ll need to consider when using an electronic data capture (EDC) system.

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