Welcome to the Clinical Research Support Center (CRSC)
of the University of Colorado Denver. This center resides within the Office
of Regulatory Compliance, overseen by the Assistant Vice Chancellor of Research Compliance,
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).
are three clinical research specialists on the regulatory team: Budget, IND/IDE and
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.
IND/IDE specialist will work with investigators to assist with IND/IDE initial and on-going submissions to the FDA.
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.
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
Quality assurance and quality improvement reviews for
research projects will be conducted by the
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.
the CRSC will support clinical trial conduct at UCD and its affiliates through
support, guidance, education, and quality assurance.
Our office is here to support you. Please contact us today.