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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:

July 2024 Update

update

  • Updated! UUSOP-02: FDA Inspections
  • New! UUSOP-02-A Supplement
  • New! UUSOP-08-A Supplement
  • Updated! UUSOP-05: Delegation of Authority
  • Updated! UUSOP-11: Investigational New Drug Applications in FDA Regulated Research
  • Updated! UUSOP-12: Investigational Device Exemption Applications in FDA Regulated Research
  • Updated! UUSOP-13: Fee Schedule
  • Updated! UUSOP-13 A Supplement
  • New! UUSOP-15: Internal Monitoring of University of Utah Clinical Studies

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January 2024 Update

January 2024 Update

  • Updated! UUSOP-02: FDA Inspections
  • Updated! UUSOP-06: Study Records Management
  • Updated! UUSOP-06-A: Study Records Management, Supplement A
  • Updated! UUSOP-07: Deviations: Documentation and Reporting
  • Updated! UUSOP-10: Monitoring Visits for Externally Sponsored Clinical Trials
  • Updated! UUSOP-13: Institutional Fee Schedule and UUSOP-13-A: Fee Schedule Cost Rationale
  • New! FAQ on Source vs. Worksheets vs. CRFs

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UUSOP-07: Deviations and Reporting

UUSOP-07: Deviations and Reporting

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."...

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January 2023 Update

SOP Updates

  • 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

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May 2022 Update

SOP Updates

  • 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

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Last Updated: 12/13/23