Reporting Requirements for Clinical Investigations of Devices

Question 1

Institutional Review Board (IRB)

Answer 1

ny board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.

Question 2

Regulation

Answer 2

a law or code issued by an executive authority or regulatory agency of a government. Regulations have the force of law.

Question 3

investigators must submit the following reports:

Answer 3

• Final Report
• Financial Disclosure Reports
• Progress Reports
• Protocol Deviations
• Use of an Investigational Device without Informed Consent
• Unanticipated Adverse Device Effects (UADEs)
• Unanticipated Problems (UPs) Involving Risks to Subjects or Others
• Withdrawal of IRB Approval

Question 4

sponsor must submit the following reports

Answer 4

• Unanticipated Adverse Device Effects (UADEs)
• -Use of an Investigational Device without Informed Consent
• Withdrawal of IRB Approval
• Device Recall