Clinical Research

All studies that require expedited or full board review must be submitted to the HSR Portal. Contact us if you aren’t sure what type of review your study requires.

Please refer to our COMIRB Training page for COMIRB's required training.

In addition to maintaining the required human subjects training, all personnel must complete the annual Conflict of Interest disclosure. Please contact the Conflict of Interest office at coi@ucdenver.edu for additional information.

No. Only the Principal Investigator, Co-Investigator(s), and Primary Contact should be listed on the personnel form in InfoEd. The PI remains responsible for ensuring that all research staff, including PRAs and study coordinators, complete the required CITI Training.

COMIRB evaluates single IRB requests on a case-by-case basis. Please contact us comirb@ucdenver.edu for any studies looking to have COMIRB serve as the single IRB.

All cancer related protocols are are required to undergo review by PRMS. Please see their Protocol Review and Monitoring System webpage for more information and the submission link.

Prior approval from the FDA is required for individual patient expanded access to investigational drugs (single patient INDs) before submitting to COMIRB. COMIRB review is required before the patient can be treated with the investigational drug, but these requests do not need to go through the standard IRB submission process. Please contact COMIRB@ucdenver.edu for assistance with submitting a request for a single patient IND.

The National Institutes of Health (NIH) defines a clinical trial as 'A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes' (Source and additional resources). 

For additional information and support with your clinical trial, please contact the Clinical Research Support Center.