Reporting Adverse Events in Medical Device Clinical Trials

This tool is based on guidance issued by the Global Harmonization Task Force on Aug. 10, 2012. The GHTF has since been replaced by the International Medical Device Regulators Forum, but the IMDRF still considers the document to be good guidance.

The objective of adverse event reporting during premarket clinical investigations is to improve protection of the health and safety of patients, users and others by identifying safety issues early in the human use of medical devices so that these can be addressed as soon as possible by modification of the device, revision of the instructions for use, modification of the clinical investigation plan or withdrawal of the device from use.

According to the GHTF, the document “represents a global model, which provides guidance on the types of adverse events associated with clinical investigations of investigational devices that should be reported by sponsors to National Competent Authorities (NCAs). It was drafted as a collaborative effort using the combined expertise of GHTF Study Groups 2 and 5. It incorporates and supplements existing regulatory requirements existing in the participating member countries and international standards specifying the planning, conducting and managing of clinical investigations. However, this guidance may not reflect all current regulatory requirements, because the present reporting criteria of the participating countries, while similarly intentioned are not identical. This document therefore provides a model towards which existing systems should move. The principles laid down in this document should be considered in the development or amendment of regulatory systems in the participating countries or other countries.”

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