ASCO research program quality assessment tool: Basics for a quality community-based research site.

Abstract

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.