Clinical Trial Compliance: What Physicians Need to Know About the FDA and IRB

For physicians new to clinical research, regulatory requirements can feel intimidating. Two important organizations you'll encounter are the Food and Drug Administration (FDA) and an Institutional Review Board (IRB).

Understanding their roles is a good starting point.

What Does the FDA Do?

The FDA regulates clinical investigations of drugs, biologics, and medical devices under its jurisdiction.

It establishes requirements designed to protect research participants and ensure that clinical trial data is reliable.

Physician investigators are responsible for conducting applicable studies according to the approved protocol, regulatory requirements, and investigator obligations.

What Does an IRB Do?

An IRB is an independent committee responsible for reviewing research involving human participants.

Its primary purpose is to help protect participants' rights and welfare.

An IRB reviews study protocols, informed consent materials, and other relevant information before approving research and provides continuing oversight as required.

Does the Physician Handle All the Regulatory Work?

Not alone.

An experienced research team can assist with regulatory submissions, documentation, training records, and preparation for monitoring visits.

However, the Principal Investigator remains responsible for appropriate oversight of the study and delegated activities.

Compliance Is a Team Effort

With the right support, physicians can participate in clinical research without managing every administrative requirement themselves.

Altitude Clinical Research provides regulatory and operational support to help community physicians conduct compliant, well-organized clinical trials.

Interested in becoming a clinical trial investigator? Contact us to learn more.