- New! Non-Industry Fee Schedule / Site Budget Guidance created.
- Updated! UUSOP-14: Safety Assessment and Reporting has been updated
- Updated! UUSOP-13: Institutional Fee Schedule and UUSOP-13-A: Fee Schedule Cost Rationale have been updated
Updates to Clinical Research SOPs
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:
- Updated! UUSOP-13: Institutional Fee Schedule (for Industry-Sponsored research)
- Updated!UUSOP-13-A: Fee Schedule Cost Rationale updated to describe the services and activities supported by the CTMS/OnCore fee. New! UUSOP-14: Clinical Trial Safety Assessment and Reporting
- New! UUSOP-13 (Institutional Fee Schedule) released
- New! UUSOP-14 (Safety Assessment and Reporting) released
- UUSOP-01 (SOP Process) updated with guidance regarding the relationship and differences between SOPs and guidance and/or work practice documents (WPD)
- USOP-04 (Investigator Responsibilities) updated with guidance on master Adverse Events (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