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CRADL POL 513 - Reporting Unanticipated Adverse Outcomes
Purpose:
To outline expectations for clients in the event of unanticipated adverse clinical outcomes during experiments conducted with animals at Charles River Accelerator and Development Labs (CRADL®).
Any clinical presentations, morbidity, or mortality, described in the Institutional Animal Care and Use (IACUC) protocol as a potential result of approved procedures, are not considered unanticipated adverse outcomes and do not require reporting. In such cases, approved research clients are expected to follow any care, monitoring, and/or humane endpoints as described in the IACUC protocol.
As the nature of scientific inquiry is to explore new questions, the IACUC recognizes that along with this comes the potential for unexpected complications or adverse effects associated with experiments. Reporting unanticipated adverse outcomes that affect animal well-being promptly allows for an informed discussion between the IACUC, the client, and the veterinary staff. This allows for a partnership in appropriately addressing the incident clinically, experimentally, and through any necessary modifications to the IACUC protocol.
Intended Audience:
All individuals and organizations entering CRADL facilities.