Skip to content
- 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)
- USOP-04 (Investigator Responsibilities) updated with guidance on master Adverse Events (AE) and Deviation logs
- UUSOP-05 (Delegation of Authority) updated to include guidance for key personnel role changes
- UUSOP-08 (Informed Consent) updated with guidance for documenting informed consent in the participant’s medical record
- New! UUSOP-11 (Investigational New Drug Application in FDA-Regulated Research) released
- New! UUSOP-12 (Investigational Device Exemption Applications in FDA-Regulated Research) released
