July 2024 Update
- Updated! UUSOP-02: FDA Inspections has been updated with the following:
- The Office of Quality Compliance has been added to list of contacts for notice of all FDA inspections.
- Procedures added for studies where there is reason to believe an FDA inspection will occur but have not received formal notification from the FDA.
- New! UUSOP-02-A Supplement has been created to provide a visual diagram of CRSO and OQC involvement during an FDA inspection.
- New! UUSOP-08-A Supplement has been created to provide guidance to study teams when conducting remote consent.
- Updated! UUSOP-05: Delegation of Authority has been updated to include that eligibility verification is commonly a PI/sub-I duty.
- Updated! UUSOP-11: Investigational New Drug Applications in FDA Regulated Research has been updated to include contact information for the University's IND specialist.
- Updated! UUSOP-12: Investigational Device Exemption Applications in FDA Regulated Research has been updated to include contact information for the University's IDE specialist.
- 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.
- New! UUSOP-15: Internal Monitoring of University of Utah Clinical Studies has been created to provide internal monitoring procedures, standards and expectations primarily for studies that do not have regular monitoring or oversight by an independent sponsor. Internal monitoring will be conducted by the Clinical Research Support Office Quality Assurance Group (CRSO QA).
A history of updates to the Clinical Research SOPs is available here.
UUSOP- 2: FDA Inspections Supplement A
The new UUSOP-02: FDA Inspections Supplement A- Institutional Assistance for FDA Inspections was created as an additional resource to study teams when preparing for an FDA inspection. Specifically, this SOP supplement provides additional guidance and clarification to research teams around campus regarding the FDA inspection procedure. It details which central University offices will be involved during each stage of the inspection process. If you have been notified of a potential FDA inspection or have reason to believe that an inspection by the FDA is likely, please refer to UUSOP-02: FDA inspections and reach out to the necessary contacts listed in section 1.
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.