Regulatory Compliance

Investigators who write and conduct their own clinical trials are referred to as Sponsor-Investigators. These types of studies are often called Investigator-Initiated Trials. Sponsor-Investigators are responsible for meeting the responsibilities of both the sponsor and the investigator, as prescribed in the FDA regulations and the good clinical practice (GCP) guidelines. If a clinical trial is designed to evaluate the effect of a drug or device intervention on a health-related outcome, the Sponsor-Investigator may be required to submit an Investigational New Drug application or an Investigational Device Exemption application with the FDA.

Additionally, all interventional clinical trials must be registered and have results reported on the ClinicalTrials.gov website. The Internal Medicine Clinical Trials Unit has the regulatory experience and expertise to help investigators with FDA applications and with the ClinicalTrials.gov requirements. For help with these issues, please contact Scott Low (801-585-1380; scott.low@hsc.utah.edu).