PROTOCOL DEVIATION REPORT
INSTRUCTIONS and USE OF FORM
Use this form only to report deviations from the IRB-approved protocols that do not rise to the level of unanticipated problems requiring prompt reporting according to HRPP policy, but notification is required by the sponsor. Otherwise, minor protocol deviations should be tracked/logged and submitted at the time of continuation (i.e. with the annual progress report).
DO NOT use this form to report Protocol Deviations that include:
• Emergency protocol deviations taken without prior IRB review to eliminate apparent immediate hazard to research
participants; and
• Accidental or unintentional deviations to the IRB-approved protocol that involved risks.
Deviations as described immediately above, Protocol Violations, Unanticipated Problems, and other events that place subjects at greater risk of harm should be submitted using the “IRB Unanticipated Problem/Event Report Form”.
Submitting the Form
An e-mailed version of this form along sent to (a signed hard copy is not required).
A Research Coordinator, Associate, or Assistant may complete and submit this form.
The Principal Investigator must be CC:’d on the e-mail submission
Principal Investigator: / Project # orAccount #:Title of Research Project(s):
Subject Identifier: / Date of Occurrence:
1)The Deviation Involved:
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Eligibility criteria
Dose, dosage schedule, or use of device
Use of prohibited concomitant medications
Lab Values
Visit schedule (missed visit, outside visit window)
Other (specify):
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2)The deviation occurred due to:
Staff error
Subject error
Circumstances
3)Explain the deviation and why it occurred:
4)Was the subject adversely affected by the deviation?
No
Yes. Explain:
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5)Was the subject informed of the deviation?
Yes
No. Explain:
6)Will the subject remain in the study?
Yes
No
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7)Describe corrective actions taken (or to be taken) to prevent future occurrence:
8)Was the sponsor notified?
YesDate Notified:
No
N/A – this is not a sponsored study.
Principal Investigator’s Assurance:By signing below, I declare that the above is an accurate and complete description of the protocol deviation and that, upon receipt of the IRB’s review; I will fully and immediately implement any corrective actions required by the IRB.
Signature of Principal Investigator
(or typed name if submitting electronically) / Date
For HRPP/IRB Office Use Only:
Non-compliance: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with either the research plan as approved by the IRB, or federal regulations or institutional policies governing such research.
Serious Non-compliance: Any behavior, action or omission in the conduct or oversight of human research that has been determined to:
*Affect the rights and welfare of participants and others;
*Increase risks to participants and others, decreases potential benefits or otherwise unfavorably alters the
risk/benefit ratio;
*Compromise the integrity or validity of the research; or
*Result from the willful or knowing misconduct on the part of the investigator(s) or study staff.
Continuing Non-compliance: A pattern of non-compliance that if allowed to continue is likely to increase risk to subjects, adversely affect the rights, welfare and safety of research subjects, or adversely affect the scientific integrity of the study.
Assessment - Check all that apply
1)Does the reported event potentially meet the above definition of “Serious Non-Compliance”?
Yes No
2)Does the reported event potentially meet the above definition of “Continuing Non-Compliance”?
Yes No
3)Does the event potentially constitute both Serious and Continuing Non-Compliance?
Yes No
If “yes” was checked for any of these 3 items please provide a comment;______
Actions Taken;
The deviation was reviewed. No apparent adverse effects (does not constitute serious or continuing non-compliance). Action taken by PI for prevention in future is acceptable.
The deviation may represent Serious and/or Continuing Non-Compliance, an “Unanticipated Problem Report” form was requested from the investigator and the issue is referred to the Full Board for further review.
Other action required: ______
______
Signature of HRPP Director or designee Date
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