The Office of Quality Compliance has created Standard Operating Procedures to be used by all individuals participating in clinical research at the University of Utah. These should be utilized to enhance quality, efficiency, data reliability and patient safety. Diversity in trial design, study sponsor, therapeutic area, investigator and coordinator experience, etc. may require unique approaches to specific clinical studies. However, establishment and adherence to SOPs can ensure compliance to Good Clinical Practice guidelines and applicable federal regulations common to clinical research of all types. The SOPs in this library define clinical research as: Please note, clinical research that does not fall under the definition of a clinical trial may choose to follow these SOPs as a way to ensure protocol compliance, data quality and meet good clinical practice. Please visit the below link posted by the Office of Quality Compliance for more information: https://qualitycompliance.research.utah.edu/clinical-research-sops.php
The scope and purpose of this SOP is to set forth requirements for the conduct of interventional clinical trials within the University of Utah. This SOP may be used to guide the conduct of other types of clinical research studies to promote quality and to meet Good Clinical Practice standards.