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