Post-Approval Monitoring (PM) can briefly be defined as procedural and\/or documentation monitoring or reviews of previously approved protocols to confirm, enable, and encourage compliance with established federal regulations and institutional standard operating procedures (SOPs) and Policies, Regulations and Rules (PRRs). PM can be briefly defined as any effort focused on determining what happens to animals after IACUC approval has been granted for their use in research, teaching, or testing.<\/p>\n\n\n\n
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The intent of the program is to enhance the quality and integrity of research practices, to increase communication between investigators, the IACUC, and animal program staff, and to foster an educational partnership among these groups to ensure animal welfare. Continuing IACUC oversight of approved IACUC protocols is required by federal regulations.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n All IACUC approved protocols may be subject to a PM visit during their three year approval period. The following types of IACUC protocols may be considered \u201chigher risk\u201d and therefore may be subject to more frequent PM visits.<\/p>\n\n\n\n \n \n\n \n \n\n The PI and relevant research personnel responsible for performing protocol experiments, hands-on procedures and\/or surgeries, data and recordkeeping should be present during the Post-Approval Monitoring visit. It is not required that the PI be present for the visit, but it is encouraged. If personnel present for the visit are unable to answer some questions, the PI may be contacted following the visit. Note, the PI is ultimately responsible for the activities associated with the study and approved IACUC protocol.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n Protocols are selected for PM based on risk assessments as described and outlined above. Once a protocol is selected, the PI will receive an email from PM personnel to schedule the visit. The visit itself will take between 30 minutes- 1 hour to complete depending on the number of active protocols, protocol complexity and the number of questions asked. A standard checklist is used to assess the protocol and animal research practices. The checklist is provided to the PI prior to the inspection. PM personnel may also ask the PI\/research staff to provide a description of one surgery and\/or procedure on the protocol to ensure current processes are congruent with the written protocol. The monitor will compare the verbal description with the approved protocol, as well as IACUC approved standards, SOPs, and relevant regulations and advise if any changes to current practices or amendments are needed. Once the visit is completed, a written report will be provided within approximately one week. If responses are required, the PI will have approximately 2-4 working weeks (15-30 days) to respond depending on the issues identified. After responses are received, the report is provided to the IACUC committee for review. If there are further questions from the committee PM personnel will follow up with the PI as needed. If there are no questions or requested revisions, the report will be finalized and saved to the protocol file.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n Minor items which require correction will be included in the post-approval monitoring report for the PI to formally respond. Any significant deficiencies which immediately impact animal health and welfare will be reported to the IACUC committee as soon as possible utilizing established adverse and noncompliance reporting processes<\/a>.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n\n \n <\/span>\n <\/span>\n
How are protocols chosen for post approval monitoring?<\/strong><\/h2>\n <\/summary>\n
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How should researchers prepare for the post approval monitoring visit?<\/strong><\/h2>\n <\/summary>\n
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Who should be present for the monitoring visit?<\/strong><\/h2>\n <\/summary>\n
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How does the Post-Approval Monitoring process work?<\/strong><\/h2>\n <\/summary>\n
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What happens if there are issues identified during the visit?<\/strong><\/h2>\n <\/summary>\n