Significant Deviation/Violation Reporting Form / A copy of this form, with the “IRB Received Stamp” above, will serve as acknowledgment of receipt. If the IRB recommends any action below, you will receive another copy of this form.
For IRB Use Only
Research is currently being conducted at:
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Select a siteAurora Advanced HealthcareAurora BayCare Medical CenterAurora Lakeland Medical CenterAurora Medical Center HartfordAurora Medical Center KenoshaAurora Medical Center of Manitowoc CountyAurora Medical Center OshkoshAurora Medical Center of Washington CountyAurora Medical Group ClinicsAurora Memorial Hospital of BurlingtonAurora Psychiatric HospitalAurora Sheboygan Memorial Medical CenterAurora Sinai Medical CenterAurora St. Luke's Medical CenterAurora St. Luke's Medical Center Rehab SheboyganAurora St. Luke's Rehab LakelandAurora St. Luke's South ShoreAurora Valley View Medical CenterAurora West Allis Medical CenterCenter for Urban Population HealthVince Lombardi Cancer ClinicsVisiting Nurses AssociationNon-Aurora facilityAll AHC sites
Aurora Medical Center (list sites):
AMG/Aurora Clinic (list sites):
VLCC (list sites):
For IRB Use Only
q This Significant Deviation Violation should be sent to ______for further review. (Chair initials ______)
q This Significant Deviation/Violation is an +Unanticipated Problem Involving Risks to Subjects or Others. (Will be reviewed under SOP 403.) Placed on ______(date) IRB meeting agenda.
Outcome of noncompliance subcommittee review:
q Significant Violation q Minor Violation (report at continuing review)
Allegation of: q *Serious NC q Substantial NC q Nonserious NC / q *Continuing NC q Noncontinuing NC
* IRB meeting agenda: ______[Allegations of serious and/or continuing NC are reviewed by the convened IRB]
q Action Plan accepted / q Further action necessary:
Outcome of IRB review if applicable:
Finding of: q Serious NC q Substantial NC q Nonserious NC / q Continuing NC q Noncontinuing NC Date letter sent per SOP 408: ______
(+A Significant Deviation/Violation is an “Unanticipated Problem Involving Risks To Subjects Or Others [Unanticipated Problem]” when it meets the definition outlined in SOP 403)
q Send an “out of window” noncompliance memo.
Use this form only to report SIGNIFICANT Deviations/Violations (as defined in Aurora IRB SOP RR 403).
This form should be sent to the RSPP office NO MORE than 10 working days after discovery of the occurrence..
Minor Deviations/Violations and protocol exceptions should be reported to the IRB at the time of continuing review.
Aurora IRB Protocol #: / Protocol Title:Principal Investigator: / Department:
Contact Person: / Phone/Fax #:
Mailing Address: / E-mail:
Subject Initials or Identifier: / Date of occurrence: / When did you receive notification of the Deviation/Violation?
1. The significant protocol Deviation/Violation involved:
Informed Consent / Breach of ConfidentialityIncorrect Study Medication or Dosage / Wrong Lab Procedure or Timing of Procedure
Record Keeping /Documentation Failure / Lapse in Continuing Review that Resulted in Subject Enrollment
Other (describe):
2. Was the Deviation/Violation instituted to protect the life or physical well-being of the subject?
3. Describe the events surrounding the Deviation/Violation:
4. Did the Deviation/Violation increase the risk or the potential for harm to the subject? Provide the rationale for your answer:
5. Was subject adversely affected by the Deviation/Violation? Provide the rationale for your answer:
[Please see Aurora IRB Policy RR 403 to determine if you need to report an Adverse Event or Injury (using Form RR 403-A).]
6. Provide specifics on the corrective action that you took to address this deviation/violation:
7. Provide your detailed plan of action to prevent this type of Deviation/Violation from happening in the future:
8. Was subject informed of the Deviation/Violation? If NO, explain why not:
9. Will subject remain in the study?
10. It is the IRB’s expectation that the sponsor be notified of this reportable event. Provide the date of notification and the sponsor’s response. If you have not yet heard back from the sponsor, provide the date that the sponsor was notified. You are expected to provide the sponsor’s response once received.
(Signature of Principal Investigator) (Date)
NOTE: The Aurora IRB requires the signature of the Principal Investigator. ) If a Cyber submission: this entry may be skipped.
Signature will be captured in Cyber.
Acknowledgment will not be sent to the Principal Investigator until the RSPP office has received the signature on this document.
Attach a PDF of the signed form to the Aurora RSPP/IRB office to an email addressed to .
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