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December 2021 Update

SOP Updates

  • 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)

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July 2021 Update

SOP Updates

  • 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

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Last Updated: 12/13/23