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  1. University of Arkansas for Medical Sciences
  2. Research and Innovation
  3. Office of Research Regulatory Affairs
  4. Regulatory Affairs
  5. ORRA Monitoring Unit
  6. Study Management Tools
  7. Deviation Log

Deviation Log

This log is to be used to record all deviations and violations, regardless of reporting requirements. Report deviation/violations that are unanticipated/ unexpected, related to the research, and that involve new or increased risk to subjects or others (UPIRTSO) to the IRB within 10 days of the event. Deviations/ Violations leading to events that are life-threatening or that have resulted in death are to be reported immediately to the IRB. All others may be reported at Continuing Review.

Subject
ID
Date of Deviation/ ViolationDate IdentifiedDescription Dev. Type*Corrective Action(s)Increased Risk to Subject or Others? (Y/N)Expected? (Y/N)Date Reported to IRBPI Initials/ Date
          
          
          
          
          
          
          

*Deviation Type: (A-) See codes below – enter the appropriate deviation code from the list.

A – Consent Procedures                                              E – Study Procedures

B – Inclusion/ Exclusion Criteria                                F – Visit Schedule

C – Randomization Procedures                                  G – Investigational Product

D – Laboratory Assessments/ Procedures              I – Other (specify): __________________

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