A “U.S. Person” is defined as a: Lawful Permanent Resident U.S. Citizen Legal Immigrant with a “Green Card” Protected Individual granted asylum or refugee status “Foreign National” includes everyone else, including foreign governments or entities not incorporated to do business in the U.S.
Determine When Export Control Laws Apply
What is export control? Export control laws regulate the export of commodities, related technical data and information, and certain services the federal government considers critical to the national security or domestic economy of the United States. The export control laws also regulate the transfer of controlled technical data to foreign nationals within the United States (“deemed exports”). “Exports” are […]
Compliance Organizational Chart
Download the Compliance Organizational Chart [PDF].
Export Management and Compliance Plan
Created 01/2017 Updated 1/5/2022 Download the Export Management and Compliance Plan (PDF).
Determine if Your Trial Needs to Be Registered on Clinicaltrials.gov
Which trials are required to be registered by law? The law states that an applicable clinical trial generally includes (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, […]
Research Participant Registry
Clinicaltrials.gov
myIRB
Click here to go to myIRB.
Register a Trial on Clinicaltrials.gov
Learn how to register a trial on clinicaltrials.gov.
Include Informed Consent Document Language for Registered Clinical Trials
For all registered clinical trails approved on or after March 7, 2012, the following language must be included in the informed consent document per FDA regulations.