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- UUSOP-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
