January 2024 Update
The University of Utah Clinical Research SOPs have recently been updated!
The following is a summary of recent updates:
- Updated! UUSOP-02: FDA Inspections: the requirement to stamp copies of documents provided to FDA inspectors has been removed.
- Updated! UUSOP-06: Study Records Management has been updated with the following:
- Alternate procedures have been added for PI/Sub-I review and signoff of participant eligibility (see section 1.4.1).
- New procedures and standards have been added for the management of study records relative to monitoring and auditing activities (see section 6.3-6.4).
- new procedures for closing out the study record (see section 7).
- An editable “Closeout Checklist” has also been provided, here.
- Updated! UUSOP-06-A: Study Records Management, Supplement A has been updated with new standards for the collection of curriculum vitae (“CVs”). Specifically, CVs only need to be collected from the PI and study personnel listed on the Delegation of Authority (DOA) log once, at the time of addition to DOA.
- Updated! UUSOP-07: Deviations: Documentation and Reporting has been updated with an additional requirement that protocol changes must be approved by IRB prior to implementation.
- Updated! UUSOP-10: Monitoring Visits for Externally Sponsored Clinical Trials has been revised to include:
- updated processes for central/remote monitoring through eReg and Epic Link, and to harmonize with corresponding updates in other SOPs.
- Processes for requesting in-person IDS pharmacy monitoring.
- Updated! UUSOP-13: Institutional Fee Schedule andUUSOP-13-A: Fee Schedule Cost Rationale have been updated with mandatory fees for participant payments, the new fee structures for fiscal year 2024, and use of the Clinical and Translational Science Institute’s (CTSI) 21 CRF Part 11 Compliance instance of REDCap.
- New! FAQ on Source vs. Worksheets vs. CRFs has been created to compare differences in purpose, creation, and use between these three related research documents.
A history of updates to the Clinical Research SOPs is available here.
An updated version of UUSOP-07: Deviations: Documentation and Reporting has been released for immediate implementation. The FDA has recently been observed to issue 483 letters to investigators that have deviated from the IRB-approved protocol with what is referred to as “sponsor approval.” Sponsor approval is not an exemption from deviation. The FDA expects investigators to obtain IRB approval for alternate procedures before implementation.
In order to protect the Institution and University investigators, UUSOP-07 will be updated to require any departure from the IRB-Approved protocol first be sent to the IRB for review and approval prior to enactment.
This will require investigators and study teams to be thoughtful when reviewing protocols. If there are areas of the protocol that are unfeasible or unnecessarily limiting, such as eligibility criteria or treatment parameters, efforts should be made to correct them before enrolling participants.
In addition, study teams are required to request an amended protocol from the sponsor for any changes that are only included in protocol administrative letters (or equivalent). Records of these requests to the sponsor must be filed in the study’s regulatory binder.
Strict adherence to the IRB-approved protocol is the most effective way to ensure research integrity and compliance, and to eliminate the risks associated with FDA investigation.
Suggestions for future SOPs are welcome!
Other questions or comments can be submitted through the U of U SOP Contact Us tool, and someone from the Clinical Research SOP Collaboration Team will contact you within 2-3 business days.