August 2026 Update

The University of Utah Clinical Research SOPs have recently been updated!

The following is a summary of recent updates:

• Updated! UUSOP-02 FDA has been updated to reflect appropriate methods of providing FDA inspectors with study record copies. 
• Updated! UUSOP-06 Supplement A has been updated to clarify that Biomedical Engineering will maintain calibration records for applicable machines.
• Updated! UUSOP-13: Fee Schedule has been updated to reflect the upcoming fiscal year's fees.
• Updated! UUSOP-13 A Supplement has been updated to reflect the upcoming fiscal year's fees.
• Did you know...UUSOP-05: Delegation of Authorityhas details on how to complete the DOA log and who should or shouldn't be included on the log.
• Did you know...UUSOP-06: Study Records Management describes expectations for completing and organizing source documents! It can also be used a reference to prepare for monitoring visits.
• Did you know…UUSOP-08: Obtaining Written Informed Consent provides essential guidance on appropriately obtaining consent, documenting consent, and re-consenting.

A history of updates to the Clinical Research SOPs is available here.

Suggestions for future SOPs are welcome! Other questions or comments can be submitted through the UofU SOP Contact Us tool, and someone from the Clinical Research SOP Collaboration Team will contact you within 2-3 business days.