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July 2021 Update

  • 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
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Last Updated: 12/13/23