Last Updated: March 2015
Institutional Review Board
700 East University Avenue, West 597
Des Moines, IA 50316
Email: IRBSubmissions@unitypoint.org
Phone: 515-263-5551
Fax: 515-263-5553
Protocol Deviation Form
The intended use of this form is for the reporting of the following, to the IRB:

Protocol violation: An accidental or unintentional change to the IRB approved protocol, that harmed
participants or others or that indicates participants or others may be at increased risk of harm.

Protocol deviations: Abnormalities within a particular study that occur with such frequency that this may
have an adverse effect on the risk/benefit analysis of the study.
Protocol violations or deviations, as defined above, may be considered by the IRB to be unanticipated problems
involving risks to participants or others. Federal regulations define these as problems that are unforeseen and
indicate that participants or others are at increased risk of harm.
Any Protocol Deviation/Violation that meets the above criteria must be reported to the IRB within 7 working days
of learning of the event. No staples, please.
1.
Project Information
PLEASE PROVIDE ALL REQUESTED INFORMATION
PI:
Site:
Complete Study Title:
IRB ID Number: (IM#/CW#/CIRB#)
Patient Initials and/or ID Number:
Research involved the use of a:
2.
Drug
Device
Procedure
Type of Event
CHECK ALL THAT APPLY
Lab test not ordered
Lab test ordered but not done
X-ray not ordered
X-ray ordered but not done
ECG not ordered
ECG ordered but not done
Subject Refused
Subject unable to schedule within protocol window
Physician not available during protocol
window
Inclusion/ Exclusion criteria not met
SAE reporting guidelines not followed
AE reporting guidelines not followed per protocol
Exclusionary medications given against
protocol guidelines
Other:
Last Updated: March 2015
3.
Event Information
Event Date (mm/dd/yyyy)
Violation
Deviation
Explanation of Event: (briefly describe)
If the event date is longer than 7 days ago, please explain why this report is being submitted late:
4.
Assessment
Please answer the following questions based on current available information
(a)
Should any immediate action be taken to protect the safety and welfare of subjects already
enrolled on this protocol or other persons associated with the research?
Yes
No
If yes, please explain your answer.
(b)
Do you recommend notifying locally enrolled participants about this event?
Yes
No
If yes, please explain your answer?
(c)
Description of Corrective Action Plan:
Please follow up with additional information as it becomes available
Person Completing Form
Date
Primary Investigator Signature
Date