Adverse event reporting form

Prompt reporting of adverse and unanticipated events is essential to protecting animal welfare and maintaining compliance with federal regulations and university policies. If an unexpected incident occurs during an approved animal research activity, investigators must report the event to the Institutional Animal Care and Use Committee (IACUC) for review. Use this form to document the circumstances of the event, actions taken to address it, and measures implemented to prevent similar occurrences in the future.

Name

This field is for validation purposes and should be left unchanged.

The NAU Institutional Animal Care and Use (IACUC) Adverse Event form must be completed for reporting any adverse or unanticipated event affecting any animal used in research, testing or teaching. This form is intended to assist the BSA staff and the IACUC in assessing what may have happened to the animal and whether any modifications need to be made to reduce the risk of recurrence.

An adverse event is defined by the NAU IACUC as any event not consistent with routine expected outcomes that results in unexpected pain, distress, or death of an animal.

Examples of events that MUST be reported include, but are not limited to the following:

· Animal death or illness from spontaneous disease not related to activities approved on a protocol.

· Unexpected animal death or injuries related to approved animal activities (e.g., allergic reactions, broken limbs, complications during or recovering from surgery, sudden death).

· An event occurring at a frequency greater than described in the approved IACUC protocol.

· Death, disease or distress due to equipment failure, transportation issues or natural disaster.

All events that impact animal health are to be immediately reported to the Attending Veterinarian (AV).

The Adverse Event Form should be completed and submitted to the IACUC Coordinator, Chairperson or AV within 24 hours of observing the event. This policy applies to all research activities, including field work.

Necropsies are typically performed on animals that die unexpectedly, so it is important to preserve the animal quickly. Whenever possible, place the animal in a bag labeled with identifying information and place in the refrigerator as soon as possible; do not freeze.

Date(Required)

Email(Required)

Protocol number(Required)

Principal Investigator(Required)

Animal species(Required)

Date event(s) occurred(Required)

Number of animals impacted(Required)

Location of event(Required)

1. Please provide a detailed description of the circumstances that led to the adverse or unanticipated event.(Required)

2. Describe any clinical signs observed before the event.(Required)

3. Provide a detailed description of how the adverse or unanticipated event was managed.(Required)

4. Provide a description of the corrective actions taken to ensure that this type of adverse event, or unanticipated problem does not occur in the future. Note that you may need to modify your original protocol to ensure that the IACUC approves of any procedural changes.(Required)

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