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{"sheet":"General Instructions","index":0,"n_rows":64,"n_cols":2,"rows_kept":64,"cut":false,"hidden":false,"merged":[[37,1,61,12],[1,1,1,12],[2,1,31,12],[63,1,63,5],[0,1,0,12]]}
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[null,"GENERAL INSTRUCTIONS\n"]
[null,"WHAT TO AUDIT:\n\n• RCOs must conduct regulatory audits using ORO's animal welfare audit tool (or equivalent) for all protocols approved by the Institutional Animal Care and Use Committee (IACUC). An initial animal welfare regulatory audit must be conducted within 3 years of the Research and Development Committee (R&DC) approval date. Subsequent regulatory audits should occur within 3 years of the previous regulatory audit. \n\n• All protocols for projects subject to just-in-time (JIT) processing before release of VA funding, or for work on any project involving sensitive species (cats, dogs, or nonhuman primates) are subject to secondary review by the office of the chief veterinary medical officer (CVMO), and documentation of that secondary review is to be maintained with the protocol. The office of the CVMO evaluates the adequacy of any forms other than the VA Animal Component of Research Protocol (ACORP) that are received. Animal studies that are not VA-funded, do not describe work with a sensitive species, and are overseen by a collaborating institution as well as by the VA, do not have to be submitted on the VA ACORP and may be submitted on the standard form required by the collaborating institution. The ACORP form is to be used for all other protocols that are not subject to secondary review. The use of the term “ACORP” in this document includes both the standard ACORP (Version 4) and the corresponding forms required by collaborating institutions and acceptable to VA. \n\n• Some R&DCs approve research projects that include more than one ACORP. Each individual ACORP should have a separate audit. The local IACUC Coordinator can provide access to each ACORP and should be contacted prior to starting the audit.\n\n• All protocols involving live animals have inherent safety concerns, requiring Subcommittee on Research Safety (SRS) oversight for which the research safety regulatory audit tool should be used. Both tools can be combined, so that data common to both forms is only recorded once. \n\n• Audit requirements are updated annually and posted on the ORO internet website and the ORO Research Compliance and Technical Assistance SharePoint site. The ORO guidance memo relevant to this reporting period is entitled “Research Compliance Officer (RCO) Audit and Training Requirements (version 2024–2025).”\n\n• RCOs are free to audit additional information that will be helpful for monitoring the quality, safety, and compliance of the facility’s research program. These additional elements should be described in the RCO standard operating procedures.       \n\n• For more information related to VA animal research, visit https://www.research.va.gov/programs/animal_research/\n"]
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[null,"HOW TO USE THIS TOOL:\n\n• Item-specific instructions, along with additional guidance information, are linked to each item and available on the \"Item Specific Instructions\" tab. Click on the item text (blue link) to access the instructions and guidance. Click \"Return\" to go back to the item. \n\n• Items with light blue response boxes require a response. Blue boxes will turn white once a response is entered. The required information can be reformatted or collected in a different manner (e.g., print out from protocol tracking system), as long as all required information is included. \n\n• All response options with light gray shading are optional, and this information is not collected by ORO. Because some RCOs have found these elements useful for auditing, these items are included here for consideration. \n\n• Drop-down options are available for many items. Click on the drop-down arrow to access the options, then click on the appropriate response, or type a drop-down response (e.g., \"Yes\", \"No\") directly into the response cell. NOTE: If a drop-down arrow appears but the list itself will not appear, change the resolution to zoom in or out. That often will fix this issue. If not, type the chosen response (e.g., \"Yes\") directly into the field.  \n\n• Some of the data on the audit tool may be not applicable to all protocols. In many cases, items that are not applicable will gray out on the audit tool based on responses to earlier items. Although these items will gray out, comments, notes, or other information can still be added for these items, if needed. If an item remains visible but does not apply, this item can be marked as “N/A.” \n \n• Responses will be highlighted in red text if the chosen response represents potential noncompliance that may require further reporting.  \n\n• Each sheet is protected to allow RCOs to \"tab\" through unlocked cells to each item that requires a response. If RCOs would like to alter the audit tool, it can be unprotected by clicking on the \"Review\" tab and selecting \"Unprotect sheet.\" There is no password required."]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Protocol Info and Approvals","index":1,"n_rows":63,"n_cols":12,"rows_kept":63,"cut":false,"hidden":false,"merged":[[5,2,5,4],[5,5,5,6],[2,1,2,13],[3,2,3,4],[3,5,3,13],[4,2,4,4],[4,5,4,13],[8,1,8,13],[9,2,9,4],[9,5,9,13],[10,2,10,4],[10,5,10,13],[11,2,11,4],[11,5,11,13],[12,2,12,4],[12,5,12,13],[13,2,13,4],[13,5,13,13],[14,2,14,4],[14,5,14,6],[14,8,14,9],[14,11,14,12],[15,1,15,4],[15,5,15,6],[15,7,15,13],[23,2,23,5],[23,6,23,7],[23,8,23,12],[18,1,18,13],[19,2,19,5],[19,6,19,7],[19,8,21,13],[20,2,20,5],[20,6,20,7],[21,2,21,5],[21,6,21,7],[22,2,22,5],[22,6,22,7],[22,8,22,12],[26,2,26,5],[26,6,26,7],[26,8,26,12],[35,1,35,13],[24,2,24,5],[24,6,24,7],[24,8,24,12],[25,2,25,5],[25,6,25,7],[25,8,25,12],[28,1,29,13],[36,1,36,7],[36,9,36,13],[37,2,39,7],[38,8,39,8],[62,1,62,5],[37,9,37,13],[41,9,41,13],[43,1,43,13],[44,1,56,13],[40,2,40,7],[40,9,40,13],[41,2,41,7],[58,1,60,13]]}
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[null,"AUDIT INFORMATION"]
[null,"1.","Date of Current Audit:"]
[null,"2.","Auditor(s):"]
[null,"3.","Status at Time of Current Audit:"]
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[null,"ADMINISTRATIVE INFORMATION"]
[null,"4.","Principal Investigator:"]
[null,"5.","Protocol Title:"]
[null,"6.","IRBNet Number:"]
[null,"7.","Protocol Number:"]
[null,"8.","Sponsor / Source of Funding:"]
[null,"9.","Study Site(s):",null,null,"VA Facility:",null,null,"Academic Affiliate:",null,null,"Other:"]
[null,null,null,null,null,"List Other:"]
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[null,"KEY PROTOCOL DATES"]
[null,"10.","Is this the First Audit for this Protocol:"]
[null,"11.","Date of Prior Audit:"]
[null,"12.","Initial Approvals Reviewed Previous Audit:"]
[null,"13.","Date Protocol Initial Approval by IACUC:",null,null,null,null,null,"Initial IACUC Approval Prior to Research:"]
[null,"14.","Date Protocol First Approved by SRS:",null,null,null,null,null,"SRS Approval Prior to Research:"]
[null,"15.","ISSO Review Required:",null,null,null,null,null,"Date of ISSO Review:"]
[null,"16.","Date Protocol  First Approved by R&DC:",null,null,null,null,null,"R&DC Approval Prior to Research:"]
[null,"17.","Date of ACOS/R Letter:",null,null,null,null,null,"ACOS/R Letter Prior to Research:"]
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[null,"The tool continues below. "]
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[null,"SUBSEQUENT REVIEWS"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"18.","Has the IACUC performed a complete review of the protocol and granted renewed approval for work to continue prior to expiration of the initial approval?"]
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[null,"19.","Date of the most recent complete review?"]
[null,"20.","Did any research occurring during the lapse in approval?"]
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[null,"NOTES"]
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[null,"NOTE: If a protocol is opened and closed without any animal research activities being initiated, completing the audit tool to this point satisfies the requirement for the Animal Welfare audit."]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Animal Research Protocol","index":2,"n_rows":61,"n_cols":10,"rows_kept":61,"cut":false,"hidden":false,"merged":[[2,1,2,13],[3,2,3,4],[10,9,10,13],[5,2,7,7],[10,2,10,7],[8,2,9,7],[3,5,3,13],[4,1,4,7],[4,9,4,13],[43,1,43,13],[44,1,58,13],[40,2,41,7],[34,1,34,13],[36,2,37,7],[38,2,39,7],[35,1,35,7],[35,9,35,13],[36,9,36,13],[38,9,38,13],[40,9,40,13],[28,1,29,13],[13,2,13,7],[13,9,13,13],[11,2,11,7],[25,2,26,7],[23,2,24,7],[14,2,15,7],[12,2,12,7],[12,9,12,13],[21,2,22,7],[18,2,20,7],[24,8,24,13],[22,8,22,13],[26,8,26,13],[60,1,60,5],[5,9,5,13],[8,9,8,13],[11,9,11,13],[14,9,14,13],[16,9,16,13],[18,9,18,13],[21,9,21,13],[23,9,23,13],[25,9,25,13],[6,8,7,13],[9,8,9,13],[15,8,15,13],[17,8,17,13],[19,8,20,13],[16,2,17,7]]}
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[null,"ANIMAL RESEARCH PROTOCOL"]
[null,"1.","List Species: (Type in blue box)"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"2.","Was the protocol submitted on an Animal Component of Research Protocol (ACORP)? If no, describe in the comments the protocol submission form that was used. "]
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[null,"3.","Does the protocol indicate the maximum number of animals to be used during the 3-year approval period?"]
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[null,"4.","Was the maximum number of approved animals exceeded?"]
[null,"5.","Does the protocol involve cats, dogs, or non-human primates?"]
[null,"5a.","If \"Yes,\" does the protocol have the approval of the VA Secretary?"]
[null,"6.","Indicate the USDA pain and distress category."]
[null,"7.","If Category E pain and distress level, is a scientific  justification provided for not relieving pain or distress?"]
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[null,"8.","Is consultation with a veterinarian during the planning stages of the research documented?"]
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[null,"9.","If the protocol states that social animals will be individually housed, is a scientific justification provided for why group housing is not being used?"]
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[null,"10.","Are all animal housing and procedure locations specified (both VA and non-VA)?"]
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[null,"11.","Are endpoint criteria for euthanasia and/or removal of animal(s) from the study described in the protocol?"]
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[null,"12.","Is a search for alternatives to animal use for procedures involving pain or distress to the animals documented in the protocol?"]
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[null,"The tool continues below. "]
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[null,"DEA CONTROLLED SUBSTANCES"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"13.","Does this protocol involve drug enforcement administration (DEA) controlled substances?"]
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[null,"14.","Are all controlled substances used in research conducted on VA property obtained through the VA Pharmacy?"]
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[null,"15.","Are the controlled substances stored securely and only accessible to authorized personnel?"]
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[null,"NOTES"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Staff Training","index":3,"n_rows":31,"n_cols":12,"rows_kept":31,"cut":false,"hidden":false,"merged":[[1,1,2,13],[10,1,10,3],[20,4,20,5],[23,4,23,5],[3,8,7,8],[3,6,7,7],[3,4,7,5],[3,1,7,3],[9,6,9,7],[17,1,17,3],[8,1,8,3],[8,6,8,7],[21,4,21,5],[15,6,15,7],[14,6,14,7],[13,6,13,7],[12,6,12,7],[11,6,11,7],[10,6,10,7],[21,6,21,7],[20,6,20,7],[19,6,19,7],[18,6,18,7],[17,6,17,7],[16,6,16,7],[16,1,16,3],[9,1,9,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[14,1,14,3],[8,4,8,5],[26,1,26,3],[15,1,15,3],[9,4,9,5],[10,4,10,5],[11,4,11,5],[12,4,12,5],[13,4,13,5],[14,4,14,5],[15,4,15,5],[16,4,16,5],[27,4,27,5],[28,4,28,5],[25,4,25,5],[26,4,26,5],[18,1,18,3],[19,1,19,3],[20,1,20,3],[21,1,21,3],[22,1,22,3],[23,1,23,3],[24,1,24,3],[3,11,7,13],[3,9,7,10],[8,9,8,10],[9,9,9,10],[10,9,10,10],[11,9,11,10],[12,9,12,10],[13,9,13,10],[14,9,14,10],[11,11,11,13],[10,11,10,13],[9,11,9,13],[8,11,8,13],[12,11,12,13],[25,9,25,10],[26,9,26,10],[27,9,27,10],[28,9,28,10],[28,11,28,13],[27,11,27,13],[26,11,26,13],[25,11,25,13],[21,9,21,10],[22,9,22,10],[23,9,23,10],[15,9,15,10],[16,9,16,10],[17,9,17,10],[18,9,18,10],[19,9,19,10],[20,9,20,10],[24,9,24,10],[24,11,24,13],[23,11,23,13],[22,11,22,13],[21,11,21,13],[30,1,30,5],[20,11,20,13],[19,11,19,13],[18,11,18,13],[17,11,17,13],[16,11,16,13],[15,11,15,13],[14,11,14,13],[13,11,13,13],[26,6,26,7],[25,6,25,7],[24,6,24,7],[23,6,23,7],[22,6,22,7],[28,6,28,7],[27,6,27,7],[24,4,24,5],[22,4,22,5],[19,4,19,5],[18,4,18,5],[17,4,17,5],[27,1,27,3],[28,1,28,3],[25,1,25,3]]}
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[null,"STUDY STAFF TRAINING"]
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[null,"1. Site Personnel",null,null,"2. All Animal Welfare Training Current?",null,"3. If Training Not Current, Initial Animal Welfare Training Ever Completed?",null,"4. Current WOC","5. Role in Study",null,"6. Comments"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Protocol Actions","index":4,"n_rows":32,"n_cols":9,"rows_kept":32,"cut":false,"hidden":false,"merged":[[8,8,8,12],[9,8,9,12],[10,8,10,12],[5,7,6,7],[5,4,6,4],[5,5,6,5],[1,1,2,12],[3,8,6,12],[7,8,7,12],[11,1,11,3],[18,1,18,3],[3,1,6,3],[3,4,4,5],[5,6,6,6],[10,1,10,3],[7,1,7,3],[9,1,9,3],[8,1,8,3],[12,1,12,3],[15,1,15,3],[16,1,16,3],[17,1,17,3],[13,1,13,3],[14,1,14,3],[3,6,4,7],[19,1,19,3],[20,1,20,3],[21,1,21,3],[21,8,21,12],[22,8,22,12],[25,1,25,3],[23,8,23,12],[24,8,24,12],[25,8,25,12],[22,1,22,3],[11,8,11,12],[12,8,12,12],[13,8,13,12],[14,8,14,12],[15,8,15,12],[31,1,31,5],[16,8,16,12],[17,8,17,12],[18,8,18,12],[19,8,19,12],[20,8,20,12],[29,1,29,3],[26,1,26,3],[27,1,27,3],[28,1,28,3],[26,8,26,12],[27,8,27,12],[28,8,28,12],[29,8,29,12],[23,1,23,3],[24,1,24,3]]}
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[null,"IACUC SUBMISSIONS, APPROVALS, AND OTHER ACTIONS"]
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[null,"1. Protocol Action \n(Amendment,  Continuing Review Approval, etc.)",null,null,"2. IACUC Dates",null,"3. Protocol Documents on File",null,"4. Comments"]
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[null,null,null,null,"Approval Date","Expiration Date","Submission  ","Approval Letters  "]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"OPTIONAL_Document Management","index":5,"n_rows":22,"n_cols":9,"rows_kept":22,"cut":false,"hidden":false,"merged":[[13,5,13,7],[14,5,14,7],[12,8,12,12],[14,1,14,4],[15,1,15,4],[13,1,13,4],[13,8,13,12],[16,1,16,4],[17,1,17,4],[14,8,14,12],[17,8,17,12],[16,5,16,7],[15,8,15,12],[15,5,15,7],[17,5,17,7],[16,8,16,12],[21,1,21,12],[22,1,30,12],[18,1,18,4],[19,1,19,4],[19,8,19,12],[18,5,18,7],[19,5,19,7],[18,8,18,12],[1,1,1,12],[5,1,5,4],[6,1,6,4],[7,8,7,12],[6,8,6,12],[2,1,4,12],[8,8,8,12],[5,8,5,12],[7,1,7,4],[8,1,8,4],[5,5,5,7],[6,5,6,7],[7,5,7,7],[8,5,8,7],[10,8,10,12],[11,8,11,12],[10,5,10,7],[12,1,12,4],[9,1,9,4],[9,5,9,7],[10,1,10,4],[11,5,11,7],[12,5,12,7],[11,1,11,4],[9,8,9,12]]}
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[null,"OPTIONAL DOCUMENT MANAGEMENT SUMMARY"]
[null,"This optional audit document management summary has been provided as a method for organizing your review of documents in preparation for the audit. "]
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[null,"Document ",null,null,null,"Date / Version",null,null,"Comments"]
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[null,"NOTES"]

{"sheet":"Item Specific Guidance","index":6,"n_rows":214,"n_cols":13,"rows_kept":214,"cut":false,"hidden":false,"merged":[[213,1,217,11],[3,1,3,12],[133,1,133,12],[99,1,99,12],[100,1,101,11],[102,1,106,11],[107,1,109,11],[110,1,113,11],[114,1,118,11],[119,1,121,11],[122,1,124,11],[125,1,128,11],[12,1,12,12],[35,1,35,12],[66,1,66,12],[4,1,5,11],[6,1,7,11],[8,1,9,11],[13,1,14,11],[15,1,17,11],[18,1,19,11],[20,1,21,11],[22,1,23,11],[24,1,25,11],[36,1,37,11],[38,1,39,11],[40,1,42,11],[43,1,50,11],[51,1,53,11],[54,1,56,11],[207,1,212,11],[77,1,78,11],[81,1,81,12],[166,1,166,12],[199,1,199,12],[82,1,84,11],[85,1,87,11],[88,1,90,11],[91,1,94,11],[134,1,136,11],[137,1,147,11],[148,1,154,11],[57,1,59,11],[60,1,62,11],[67,1,74,11],[75,1,76,11],[200,1,206,11],[167,1,172,11],[173,1,176,11],[177,1,186,11],[187,1,190,11]]}
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[null,"INSTRUCTIONS AND GUIDANCE: AUDIT INFORMATION"]
[null,"1. Audit Date: Indicate the date the current audit started.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"2. Auditor: Indicate who conducted the current audit.\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"3. Status at Time of Audit: Indicate the protocol status at the time of the current audit. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: ADMINISTRATIVE INFORMATION"]
[null,"4. Principal Investigator: Enter the name of the Principal Investigator (PI) or Local Site Investigator (LSI).\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"5. Protocol Title: Enter the title of the individual protocol that is being audited. If the individual protocol is part of a larger, multi-protocol project, include a cross reference to the larger project. \t\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"6. IRBNet Number: Enter the IRBNet number for the protocol. If the protocol does not have an IRBNet number, enter \"N/A.\"\t\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"7. Protocol Number: Enter the protocol number or other identifier for the protocol. Indicate \"N/A\" if no identifier other than the IRBNet number is used.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"8. Sponsor/Funding: Enter the sponsor or source of funding. Indicate \"N/A\" if there is no sponsor or funding.\n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"9. Study Sites: Indicate where the protocol-related activities are taking place. Select all that apply.\n\n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: KEY PROTOCOL DATES"]
[null,"10. First Audit: Indicate whether this is the first regulatory audit conducted for this protocol.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"11. Date of Prior Audit: If this is not the first regulatory audit conducted for this protocol, indicate the date of the last audit. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"12. Initial Approvals Reviewed in Previous Audit: Indicate whether the initial approvals were reviewed as part of a previous audit. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"13. Initial Approval by IACUC: Indicate the date the protocol received initial approval by the IACUC. Then indicate whether IACUC approval was obtained prior to the initiation of any research activities. \"Initial\" refers to the date of the first IACUC approval for the study. If the IACUC considers the ACORP a \"new\" protocol after a triennial review, the dates for initial approval and most recent triennial review may be the same. If the IACUC does not consider the ACORP a \"new\" protocol after a triennial review, the dates for initial approval may be the date the first time the IACUC reviewed and approved the study and may be different from the most recent triennial review after the initial audit. Consult with the IACUC about whether the ACORP is considered a \"new\" protocol after triennial review.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"14. SRS Approval: Indicate the date the protocol received SRS approval and whether SRS approval was obtained prior to the initiation of any research activities. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"15. ISSO Review Required: Indicate whether ISSO review is required for the protocol (if the protocol involves photographic or video images of category D or category E procedures in animal research). Then indicate the date of ISSO review, if required. \n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"16. R&DC Approval: Indicate the date the protocol received R&DC approval and whether R&DC approval was obtained prior to the initiation of any research activities.  ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"17. ACOS/R Letter: Indicate the date the ACOS/R letter was signed and whether the ACOS/R letter was signed prior to the initiation of any research activities. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: SUBSEQUENT REVIEWS"]
[null,"18. Complete Review and Renewed Approval: Indicate whether the IACUC has performed a complete review of the protocol. Triennial complete review and approvals are required for any work with animals (including non-USDA-regulated species) to continue beyond the third anniversary date of the original IACUC approval or previous renewal of approval. VHA Directive 1200.07, VA Research with Animals (released May 23, 2023) §10.d(5) and (6) requires only that IACUC approval be renewed according to the requirements of the USDA Animal Welfare Regulations and the PHS policy, which agree that IACUC approval expires no later than 3 years after it is granted. The requirements for continuing reviews are left to the discretion of the IACUC.  ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"19. Date of Most Recent Complete Review: Enter the date of the most recent complete review.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"20. Research During Lapse: Indicate whether any research occurred during a lapse in approval. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: ANIMAL RESEARCH PROTOCOL"]
[null,"1. Species: Type all animal species covered by the ACORP into the blue response box. The IACUC has flexibility to determine if multiple species can be included in one ACORP. The RCO should note the species identified in item A.4 of the main body of the ACORP.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"2. ACORP: Indicate whether the protocol was submitted on an Animal Component of Research Protocol (ACORP). If \"No,\" describe the protocol submission form that was used in the \"Comments.\"\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"3. Maximum Number of Animals: Indicate whether the protocol specifies the maximum number of animals to be used during the 3-year approval period. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"4. Maximum Number of Animals Exceeded: Indicate whether the maximum number of animals to be used during the 3-year approval period (as specified in the protocol) was exceeded. The maximum number of animals approved for use is found in ACORP, Section I. RCOs should ensure that the maximum number of animals has not been exceeded.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: ANIMAL RESEARCH PROTOCOL (continued)"]
[null,"5./5a. VA Secretary Approval for Dog, Cat, and NHP: Indicate whether the protocol has the approval of the VA Secretary, if required. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"6. USDA Pain and Distress Category: Indicate the USDA pain and distress level. Select the highest level from the dropdown and note any other categories in the comments. Category D and Category E require ISSO review of the ERDSP if there are photographic or video images of the animal research. Assignment of animals to USDA categories  B, C, D or E must be documented. The same animal cannot be assigned to more than one USDA category and reporting should reflect the highest category that applies.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"7. Scientific Justification for Category E: Indicate whether the scientific justification is documented. The justification for category E pain/distress is found in the ACORP in Section K.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"8. Veterinarian Consultation: Indicate whether consultation with the veterinarian during the planning stages of the research is documented (e.g., pre-review of the proposed research). VA policies require consultation with a veterinarian during the planning stages of research. This information is found in the ACORP, Section L.  ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"9. Individually Housed: Indicate whether there is a documented scientific justification for why group housing is not being used if the protocol states that social animals will be individually housed. The Guide for the Use and Care of Laboratory Animals, 8th Edition states that social animals are housed in stable pairs or groups, unless a scientific justification is provided to justify individual housing. The justification for housing social animals singly is found in the ACORP, Section M. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"10. Housing and Procedure Locations: Indicate whether all animal housing and procedure locations are specified in the protocol. Information on housing sites is found in the ACORP, Section N.\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"11. Endpoint Criteria: Indicate whether the endpoint criteria are described in the protocol. Endpoint criteria are used to define objective criteria for when an animal will be removed from a study or euthanized. This information is found in the ACORP, Section T. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"12. Alternatives: Indicate whether the search for alternative to animal use procedures is described in the protocol. Investigators must consider less painful/stressful alternatives to procedures, options to replace the use of animals, and provide assurance that the proposed research does not unnecessarily duplicate previous work. Information on alternatives is found in the ACORP, Section W.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: DEA CONTROLLED SUBSTANCES"]
[null,"13. DEA Controlled Substances: Indicate whether this protocol involves DEA controlled substances. Items 14 and 15 will remain visible if the protocol is being conducted at the VA (based on the response provided on the tab \"Protocol Info and Approvals\" Item 9). ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"14. Controlled Substances Obtained through VA Pharmacy: Indicate whether all controlled substances used in research conducted on VA property are obtained through the VA Pharmacy. Information on procurement of controlled substances is found in the ACORP, Section X and is addressed in VHA Directive 1108.01 (01), Controlled Substances Management, §4.j. This citation specifies that “[a]ll controlled substances for use in research (animal or human) conducted on VA property or facilities are ordered through and received by Pharmacy Service,” and goes on to acknowledge that some “specialized veterinary controlled drugs used in animal research at a VA medical facility will not be available through vendors used by the pharmacy. In such a case, the Chief of Pharmacy should be consulted to ensure that the pharmacy is involved in arranging the purchase of or transfer of such drugs through a non-VA institution for use in the VA program.” If the study is conducted at the VA and controlled substances are not obtained through the VA pharmacy (this is documented in ACORP X.1), document the explanation given for the “Other” option of ACORP X.1.b and whether the Chief of Pharmacy has been consulted. RCOs are not expected to validate the explanation.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"15. Controlled Substances Stored Securely: Indicate whether controlled substances are stored securely (e.g., in a secured locked cabinet or automated dispensing machine such as a Pyxis or Omnicell) and only accessible to authorized personnel. VHA Directive 1180.01 (1), Controlled Substances Management, §4.g.9(b) specifies that “controlled substances must be stored in a secured locked cabinet or cart with electronic access or locked commercial automated dispensing system” if stored outside of the pharmacy vault. RCOs may go onsite to confirm that controlled substances are appropriately stored; alternatively, RCOs may check with the controlled substances coordinator for this information.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: STAFF TRAINING"]
[null,"RCOs should check that training related to animal research is current for all research staff (identified in ACORP E.1 and E.2) participating in the protocol on the date of the audit or date of closure if the study previously closed. No look-back period is expected. Additionally, RCOs should ensure that any species-specific training has been completed (refer to item 1 on the audit tool tab \"Animal Research Protocol\"). Refer to ORD Guidance on ACUP Training Requirements for current training requirements: https://www.research.va.gov/programs/animal_research/required_training.cfm ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"1. Site Personnel: For research staff identified only by job title in the protocol, RCOs may need to request a list of names of staff from the PI. RCOs should audit training that is specific to the research program and do not need to confirm additional training required of all VA or VHA employees. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"2. All Animal Training Current: Research-specific training should be audited to ensure it is current at the time of the audit or date of closure if the study previously closed. Unlike some other auditing elements, there is no expectation that training is checked for any lapse during the last 3 years or since the last audit. RCOs should ensure that training is current at the time of the audit or study closure. The Research Service is not required to maintain a real-time (up-to-the minute) record of training compliance. If relying on a list of training compliance maintained by the Research Service, RCOs must check any items that appear to indicate a deficiency (lapse in training) against primary records (e.g., TMS) to verify whether a deficiency in fact exists at the time of the RCO audit. Note that study staff only need to be current on training required for working with animals when they are identified as research personnel on an active protocol for working with the animals. If they are not doing any work with animals, there is no need for the training to be kept “current.”",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"3. Training Ever Completed: If training required for research with animals is not current as of the time of the audit, RCOs should check if required training was ever completed for this staff member's involvement in this research. If there is no evidence of training ever being completed, this should be reported as noncompliance. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: PROTOCOL ACTIONS"]
[null,"RCOs should review the IACUC file, including the protocol and all IACUC actions since initial approval or the last audit. This tab can be used to document the protocol history, including substantive actions of the IACUC related to the audited protocol in chronological order. This protocol history would include initial approval, amendments, subsequent review/approval, and changes in staff. RCOs should note any possible compliance issues related to IACUC actions using the \"Comments.\" RCOs may obtain and organize the information in the manner they choose to be most useful (e.g., attach a list of protocol actions as taken from the protocol tracking system used by the facility).     ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"2. IACUC Dates: The date should be verified for every IACUC action. This will allow RCOs to determine, as relevant, the timeliness of the action and the timeliness of any further actions that may be required. Date of expiration of the action, if any, should also be recorded. If the IACUC action was anything other than approval, make a note in the \"Comments.\" The date of Research and Development Committee (R&DC) approval of IACUC actions (if required) can be recorded in the \"Comments\" if that is something the facility chooses to review as part of the audit.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"3. Protocol Documents on File (Submission on File / Approval Letters on File): The protocol file should include documentation of the submission of the request for an action and a letter communicating the action to the PI by either the IACUC, ACOS, or as designated by policy. Record whether appropriate documentation of required action notification is found during the audit, or “N/A” if no documentation is required for the action by policy.",null,null,null,null,null,null,null,null,null,null,"RETURN"]

{"sheet":"Dropdowns","index":7,"n_rows":6,"n_cols":4,"rows_kept":6,"cut":false,"hidden":true,"merged":[]}
[]
["Yes","Open","PI","Category B"]
["No","Closed","SC","Category C"]
["N/A",null,"SI","Category D"]
[null,null,null,"Category E"]
[null,null,null,"N/A"]