Clinical Investigation is a systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals. Any clinical investigation must:
• be part of the clinical evaluation process
• follow a proper risk management procedure to avoid undue
risks
• be compliant with all relevant legal and regulatory
requirements
• be appropriately designed (see below)
• follow appropriate ethical principles
Clinical investigations, including clinical testing of medical devices, shall be conducted in accordance with the ethical principles that protect the rights, safety, and well-being of human subjects, which are the most important considerations