Building and implementing a quality assurance/quality improvement program for clinical research.

Background: A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices.

Objective: One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical and safe.

Methods: The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program's goal was to improve research design quality and from the start of the project, "find it, fix it", leading to improved PI education, without being viewed as punitive.

Results: Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth.

Conclusion: A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational and well accepted by all clinical research stakeholders.