ctd 2020 4

Clinical Trials Day: Regulatory

Clinicals Trials Day is May 20, 2020, and we are celebrating all roles in research teams this week! Today's highlight is Regulatory staff.

Regulatory personnel, typically given the title Regulatory Specialist or Regulatory Coordinator, handle all aspects related to clinical trial regulations. The bulk of this work is submitting studies to the Institutional Review Board (IRB).

The IRB is an administrative body that protects the rights and welfare of research participants. Each organization, such as a college or university, that conducts research has its own IRB. The IRB reviews all research involving human participants. The IRB can approve, disapprove, modify, and monitor all research studies. When a study is approved by the IRB, the study can go forward.

In addition to submitting studies to the IRB, regulatory personnel ensure all studies and people involved are compliant with research regulations. They also create regulatory and quality assurance documents and processes. Regulatory personnel also track study progress.

MNCCTN’s Regulatory Specialist is Rana Leed, MPH. Thank you, Rana!