Skip to content

UUSOP-07: Deviations and Reporting

UUSOP-07: Deviations and Reporting

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."...

Share this article:

January 2023 Update

SOP Updates

  • 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

Share this article:
Last Updated: 12/13/23