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 provide standardizes processes that support the 1U4U vision.
Since 2019, the Office of Quality Compliance has been creating SOPs to 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 clinical research of all types.
The maintenance and development of SOPs is an essential priority! In the first half of 2021, the following updates have been released:
- UUSOP-04 (Investigator Responsibilities) updated with guidance on master AE and Deviation logs
- UUSOP-05 (Delegation of Authority) updated to include guidance for key personnel role changes
- UUSOP-08 (Informed Consent) updated with guidance for documenting informed consent in the participant’s medical record
- New! UUSOP-11 (Investigational New Drug Application in FDA-Regulated Research) released
- New! UUSOP-12 (Investigational Device Exemption Applications in FDA-Regulated Research) released
These updates, along with all Clinical Research SOPs, can be found HERE.