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This document outlines the Standard Operating Procedure (SOP) for reporting adverse events (AEs) in animals used in biomedical research at the University of Pittsburgh. It defines AEs, establishes reporting requirements, and details the responsibilities of investigators, veterinary staff, and the Institutional Animal Care and Use Committee (IACUC). The SOP aims to enhance animal welfare and research effectiveness by ensuring timely documentation and review of unexpected clinical outcomes.

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What needs to be reported to OLAW?

Annual Reports to OLAW changes in the institutions program of animal care and use or facilities (PHS Policy IV. changes in the Institutional Official (IO) changes in the Institutional Animal Care and Use Committee (IACUC) membership. dates that the IACUC conducted its semiannual evaluations of the program and facilities.

Which of the following is not an IACUC activity?

The option C) Conducting animal experiments is not a function of the Institutional Animal Care and Use Committee (IACUC) at an institution. The IACUC is responsible for ensuring that any research or protocol involving animals is ethical and humane.

What is an adverse event in CFR 21?

AAALAC requires accredited institutions to promptly report adverse events, including unexpected animal deaths and allegations regarding compromised animal welfare. We investigate these reports and, if deemed appropriate, require corrective action within a set period of time.

What are the 4 criteria for adverse event reporting?

Adverse event means any untoward medical occurrence associated with the use of a drug product in humans, whether or not it is considered related to the drug product.

What events are reportable to the IACUC?

Investigators must notify the IACUC regarding any unanticipated deaths, adverse events, unexpected study results or a phenotype that negatively impacts the welfare of an animal. Notification must still occur even if the issue has been identified and corrected.