citation_inspection: 77

Several technicians performing procedures under Protocol A were trained between March 2022 and July 2022. According to their training qualification section of the protocol, some of the sub-investigators will perform procedures “under the guidance of and learning from senor investigators”. There was no indication a senior investigator was present for some studies in progress and assistance was sought from the vet staff or others not listed on the protocol. Additionally, there is no record of a process that ensures that sub-investigators with limited experience with the species and/or procedures on the study are reevaluated to determine proficiency to perform study procedures on their own. Per this Section, it the responsibility of a research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in a study are qualified to perform the procedures outlined in the protocol. This requirement ensures that processes and procedures established and approved by the IACUC are followed for the welfare of the study animals. Qualifications of personnel must be reviewed with sufficient frequency to ensure all study personnel can perform all study procedures without supervision. A process for determining proficiency in performing procedures on the protocol must be established and the personnel qualifications should be updated accordingly. Correct by January 31, 2023. The inspection was conducted from 11/16-18/ 2022. This inspection and exit interview were conducted with the facility representatives and the IO. n