Clinical Trials conducted under the auspices of WVU must be registered with the WV Clinical and Translational Science Institute (WVCTSI) Center of Excellence (COE).
- NIH Definition of a Clinical Trial
- FDA and NIH Clinical Trial Definitions
- FDA Regulatory Policy
External IRB Information
Follow the guidance for submitting protocols to the WVU IRB for all research conducted under the auspices of WVU whether WVU is or is not the IRB of Record. If you are new to WVU, please review the Get Started and Training sections of this website.
Before research can begin, the WVU IRB must approve (if WVU is IRB of Record) or acknowledge (if WVU is not the IRB of Record) protocol applications in the protocol submission system.