Children's Hospital Colorado

Regulatory Affairs at Children's Hospital Colorado

The mission of research regulatory affairs

  • To provide regulatory support for researchers in the areas of protocol development, development and review of IRB documents, creation of study schemas, consent form development, IND/IDE applications, and ancillary service research service requests
  • Works as a liaison between researchers and the Colorado Multiple Institutional Review Board. Interprets Children's Hospital Colorado, IRB, state and federal regulations for researchers and their staff
  • Assesses and analyzes the learning needs for new and experienced researchers, develops education modules, and provides training for research staff
  • Chairs the Organizational Research Risk & QI Review Panel (ORRQIRP), which reviews greater than minimal risk studies to determine feasibility and acceptable levels of organizational risk with the goal of enhancing research at Children's Colorado
  • Provides oversight of program evaluation projects and quality improvement research

Primary contact:

David Staley
Children's Hospital Colorado Administrative Pavilion
4th Floor, Southeast Corner, Box 198

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