Investigator Obligations in FDA-Regulated Clinical Investigations of Devices

Question 1

Contract Research Organization (CRO)

Answer 1

an organization that provides support to sponsors of clinical trials that choose to outsource some or all of its services on a contract-basis. Sponsors can delegate all or part of the sponsor’s trial duties to the CRO.

Question 2

Investigator

Answer 2

an individual who actually conducts a clinical investigation (that is, under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team).

Question 3

Sponsor

Answer 3

entity that takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. Note: the sponsor is often but not always the entity that funds the clinical research.

Question 4

Unanticipated Adverse Device Effect (UADE)

Answer 4

a serious adverse effect on the health or safety, or any life-threatening problem, or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects according to FDA regulations at 21 CFR 812 (Investigational Device Exemptions 2018).

Question 5

Sponsor Requirements for Selecting Investigators

Answer 5

expertise, resources, and access to the desired subject population
potential investigator must disclose potential conflicts of interest

Question 6

Investigator Agreement

Answer 6

commitment by the investigator to:

• Conduct the investigation in accordance with the agreement, the investigational plan (or protocol), the applicable regulations and standards, and the conditions of approval imposed by the reviewing IRB or applicable regulatory authority.
• Supervise all testing of the device involving human subjects.
• Ensure that the requirements for obtaining consent are met.

Question 7

Financial Disclosures

Answer 7

Investigators are required to disclose the financial interests they might have in the sponsoring organization and in the outcome of the investigation (21 CFR 54).

Question 8

report UADEs when

Answer 8

report UADEs to the sponsor and the reviewing IRB within ten (10) working days after becoming aware of the event.