University of Colorado Denver

The CRSC consists of a regulatory team of senior clinical research specialists whose role is to guide investigators in the development of new protocols, preparation for submission to COMIRB and other applicable committees (including Biosafety, University Hospital's Research Office (HRRC), the CTRC/CTO--pediatric and adult), with the larger goal of streamlining clinical research protocols through COMIRB in a more timely fashion while maintaining compliance within the Human Research Protection Program (HRPP). 

There are three clinical research specialists on the regulatory team: Budget, IND/IDE and Pediatric/Adult. 

The Budget Specialist will work closely with the research team to help them develop a budget for their clinical trial that covers all research expenses and adheres to requirements set forth by the site where the research will take place. 

The IND/IDE specialist will work with investigators to assist with IND/IDE initial and on-going submissions to the FDA. 

The Pediatric and Adult Specialist will work with the investigative team to ensure all applicable local and federal regulations are followed as they relate to the specifics and nuances of both adult and pediatric clinical research.

The CRSC also has two Clinical Research Facilitators.  Their role is to guide the investigator in the submission process, study start-up procedures, and trial conduct.  Their role is as advisor and guide; no hands-on production will be provided.

Quality assurance and quality improvement reviews for research projects will be conducted by the regulatory team.  

The CRSC will facilitate the improvement of policies and practices in clinical research at UCD to continually maximize the protection of human subjects, and to ensure the quality and safe conduct of research projects.

Thus the CRSC will support clinical trial conduct at UCD and its affiliates through support, guidance, education, and quality assurance​​.  

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