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/ Violation | Date Identified | Description | Dev. Type* | Corrective Action(s) | Increased Risk to Subject or Others? (Y/N) | Expected? (Y/N) | Date Reported to IRB | PI 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): __________________