The Development of a Core Set of Standard Operating Procedures in Order to Promote Quality, Consistency, and Efficiency in the Conduct of Oncology Clinical Research at the University of Texas Southwestern




Grant, Leon


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There is an increasing need for standardization of tools and methods involved in the management of complex study tasks from study set-up and initiation, through subject recruitment and treatment, to study closure. Standardizing daily clinical research activities by establishing new, regularly updated procedural protocols improves management tasks. This includes adherence to FDA regulations and compliance with Good Clinical Practice (GCP) Guidelines, offering easy monitoring of adverse events and clinical trial data, and promoting quality, consistency, and efficiency in the conduct of clinical trials. This is especially true in the case of the University of Texas Southwestern, Simmons Comprehensive Cancer Center Clinical Research Office that conducts and manages a diverse array of cancer-related clinical research including skin, lung, breast, and gastrointestinal cancers. The focus of this research project was the generation of a core set of Standard Operating Procedures (SOPs) in the conduct of oncology clinical research at this site. The purpose of these SOPs is to promote quality, consistency, and efficiency of research conduct. An SOP Supplement was created to offer a roadmap on how to read and use the SOPs. This accompanies an SOP Awareness Program that was used to communicate the rationale for regulations, policies and procedures. The intention of this SOP Awareness Program was to foster a culture of compliance by the research staff. Furthermore, a Concerns-Based Adoption Model (CBAM) questionnaire was used to address the individual’s concerns about the innovation, its implementation and its adaptation. A daily journal log detailed the internship experience in terms of the daily activity and tasks performed towards the successful completion of the research project.