Posts

• 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

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."...

• 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

• 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)