GHTF guidance on Clinical Investigations - General Principles, Design and Ethics

• Date: February 11, 2010
• Source: www.ghtf.org

The guidance contained within this document is intended to apply to medical devices generally and combination products regulated as medical devices. It is not intended to cover in vitro diagnostic medical devices. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support a marketing authorization application. Some aspects of this document may apply to studies conducted following commercial release of a device. Future GHTF documents will specifically address post-market clinical follow-up studies.

This document provides guidance on

• when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see GHTF/SG1/N041 – “Essential Principles of Safety and Performance of Medical Devices”); and
• the general principles of clinical investigation involving medical devices

Sections

• General Principles When Considering the Need for a Clinical Investigation
• General Principles of Clinical Investigation Design
• Ethical Considerations for Clinical Investigations

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