CIRB PROTOCOL DEVIATION/NON-COMPLIANCE
REPORT FORM
1. CIRB Reference No:
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2. Protocol Title:
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3. Principal Investigator:
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4. Designation/
Department/ Institution:
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5. Description of Event
a. Please describe in detail the nature of the event including the date of occurrence. (If
subjects are involved, please indicate the subject identifier.)
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b. Please describe why or how the event occurred. Describe the outcome.
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c. In your judgement, did the event affect the safety, rights or well-being of the Research
Participant (and/or others)?
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d. Please describe any corrective action, if applicable, taken for the event.
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e. Please describe any preventive action plan to prevent the recurrence of the event in future.
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f.
Any other comments.
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g. Has this event been reported to the Study Sponsor/Grant Body?
Not Applicable as there is no study sponsor or grant body.
Yes. Please describe response if any.
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No. Please provide rationale for not reporting.
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CIRB Protocol Deviation/Non-Compliance Report Form
Version 2.0, 17 Dec 2013
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9. Declaration Of Principal Investigator:
I confirm that the information submitted in the above report is true and accurate at the date of
submission of the report.
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Principal Investigator’s Signature
Full Name:
Institution:
Department:
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Date
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Choose from list
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Guidance for CIRB Protocol Deviation/Non-Compliance Report Form
This report form should be submitted to the CIRB secretariat once PI is aware of the protocol deviation/noncompliance but no more than 14 calendar days. All sections must be completed. PIs are obliged to suspend their
research immediately pending their report to the IRB if deviations are substantial or will likely result in greater
harm or greater likelihood of harm to the subjects.
Definitions
Protocol Deviation: is an unplanned excursion from the protocol that is not implemented or intended as a
systematic change.
 A protocol deviation could be a limited prospective exception to the protocol (e.g. agreement between
sponsor and investigator to enrol a single subject who does not meet all inclusion/exclusion criteria). Like
protocol amendments, deviations initiated by the investigator must be reviewed and approved by the IRB
and the sponsor prior to implementation, unless the change is necessary to eliminate an immediate
hazard to the human subjects.
 Protocol deviation is also used to refer to any other, unplanned, instance(s) of protocol noncompliance.
For example, situations in which the investigator failed to perform tests required by the protocol or
failures on the part of the subjects to complete scheduled visits as required by the protocol.
Non-Compliance: is a failure by an investigator or any study team member to abide by the policies and
procedures of CIRB or applicable regulations governing the protection of human subject research. Some
examples of non-compliance include but are not limited to:
 Failure to obtain prior approval for research
 Failure to obtain renewal of approval for research
 Failure to obtain informed consent when required
 Failure to use the latest CIRB approved version of the protocol or consent form
 Failure to report an adverse event report according to the CIRB timeline and procedure
 Performance of research at an unapproved study site
 Performance of a drug trial without a valid HSA Clinical Trial Certificate (CTC)
 Any other failure to adhere to regulations, policies and procedures related to research
For CIRB Official Use Only
Category of Review
Full Board Review
Expedited Review
Note and File
Request for additional Information
Follow up action required
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Reviewer’s Name
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Reviewer’s Signature
Date
CIRB Protocol Deviation/Non-Compliance Report Form
Version 2.0, 17 Dec 2013
Page 2 of 2