Children's Hospital Colorado

Regulatory Affairs at Children's Hospital Colorado

Mission of 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 Hospital Colorado. Provides oversight of program evaluation projects and quality improvement research.

Primary contact:

Regulatory.Research@childrenscolorado.org

David Staley
Research Operations Manager
Children's Hospital Colorado Administrative Pavilion
4th Floor, Southeast Corner, Box 198
720-777-4781
David.Staley@childrenscolorado.org

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