UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

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IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Other Reportable Information or Occurrence (ORIO)Guidance

• Miscellaneous
  • Audits and Inspections
  • Reports from oversight agencies
  • Subject incarceration
  • Wards of State
    
    
• Accidents/Incidents
  • Involving Subject
  • Involving Study Data/Specimens
  • Involving Study Facility
    
    
• Protocol Deviations/Violations
  • Deliberate Procedural Deviations (including "protocol exceptions")
  • Accidental Procedural Deviations
  • Appointment/Visit Deviations
  • Dosage/Intervention Errors or Deviations
  • Breach of Confidentiality or Privacy
  • Consent Process Deviations or Problems
    
    
• Complaints

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