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FORM # - F-006

Protocol Deviation, Violation and Exception Reporting Form

Use to report information items listed on the bottom of this form

IRB Number:

Acronym:

Protocol Title:

Investigator:

Protocol Deviation Protocol Violation Protocol Exception

PROTOCOL DEVIATION OR VIOLATION, IF N/A SKIP SECTION.
  1. Description of problem:
  2. Date investigator was notified:
  3. Date sponsor was notified of the event (if applicable):
  4. Was the deviation/violation related to the:

Investigator Staff Subject Circumstance

  1. Did the deviation/violation harm subjects or others? No Yes
  2. Did this protocol deviation/violation result from a change in protocol prior to IRB approval in order to eliminate immediate harm to a subject or others? No Yes

If “Yes”, please explain:

  1. Describe any actions taken to prevent reoccurrence:
  2. Has this deviation/violation occurred before: No Yes

If “Yes”, please explain:

  1. Is this deviation/violation event likely to reoccur? No Yes

If “Yes”, please explain:

IN THE OPINION OF THE INVESTIGATOR
  1. Does the protocol need revision? No Yes

If yes, submit a Request for Modification Form.

  1. Does the consent document need revision? No Yes

If yes, submit a Request for Modification Form.

PROTOCOL EXCEPTION REQUEST: IF N/A, SKIP SECTION.
  1. Describe the protocol exception:
  2. Justify why the protocol exception is needed and should be granted:
  3. Briefly discuss the impact of the exception on the risks and/or benefits to the individual participant:
  4. Will this exception affect the overall validity of the study? No Yes

If “Yes”, please explain:

  1. Will this protocol exception be discussed with the participant? No Yes

If “No”, provide a justification for not discussing the exception with the participant.

If “Yes”, describe how the exception will be presented and discussed with the participant. (Attach any written materials or script or oral presentation to be provided to the subject)

  1. Does this protocol exception require pre-approval from a sponsor or funding agency?

No Yes If “Yes” provide a copy of the sponsor’s approval with this exception.

  1. Does this protocol exception require pre-approval from the FDA? No Yes

If “Yes”, provide documentation of the FDA’s approval of this exception.

I have personally reviewed this information and agree with the above assessment:
SIGNATURE OF INVESTIGATOR / DATE
DEFINITIONS:
Protocol deviation(s): means a minor or administrative departure from the IRB-approved protocol procedures (e.g., the protocol, informed consent document, recruitment process or study materials) that was made without prior sponsor and IRB approval. It is an accidental or unintentional change to, or non-compliance with the research protocol that neither (a) increases the risk or decreases the benefit; (b) significantly affects the subject’s rights, safety or welfare and/or the integrity of the research data.
Protocol exception:A one time, intentional, time sensitiveaction or process that departs from the IRB approved study protocol, intended for one occurrence. The protocol exception is usually evaluated by both the sponsor or funding agency (and FDA, if applicable) and the IRB in order to determine that it does not increase the risk to the subject or jeopardize the integrity of the research data. Documentation of sponsor (and FDA, if applicable) pre-approval and IRB approval of the exception should be maintained in the investigator’s research study file.
Protocol violation(s): means an accidental or unintentional change to, or non-compliance with the IRB-approved procedures (e.g., the protocol, informed consent document, recruitment process or study materials) without prior sponsor and IRB approval. Protocol violations generally increase risk and/or decrease the benefit; affect the subject’s rights, safety or welfare and/or the integrity of the research data.
IRB Use Only
Problem involves: (Check all that apply)
An unanticipated problem involving risks to subjects or others
Suspension or termination of IRB approval
Serious non-compliance
Continuing non-compliance
Non-compliance that is neither serious nor continuing
None of the above / (Must be completed by a Designated Reviewer)
Serious
Unanticipated
Related / Not serious
Anticipated
Unrelated