Research quality and integrity is essential to the mission of the University of Utah. Standard Operating Procedures (SOPs) help to ensure consistency and compliance in conducting clinical research and provides standardized processes that support the 1U4U vision.
The University of Utah Clinical Research SOPs should be used by all individuals and groups conducting clinical research at the University of Utah. These SOPs should be utilized to enhance quality, efficiency, data reliability and patient safety. Although differences across studies may require unique approaches to conducting specific clinical studies, the establishment and adherence to SOPs can ensure compliance to applicable federal regulations and Good Clinical Practice guidelines that are common to research of all types.
The maintenance and development of SOPs is a constant priority! Suggestions for future SOPs can be submitted HERE. Other questions or comments can be submitted on the UU Clinical Research SOPs CONTACT US page, and someone from the SOP Collaboration Team will contact you within 2-3 business days.
The following updates are provided for notification and education:
An updated version of UUSOP-07: Deviations - Documentation and Reporting will be released in December 2023 for immediate implementation. The FDA has recently been observed to issue 483 letters to investigators that have deviated from the IRE-approved protocol with what is referred to as "sponsor approval."...