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{"sheet":"General Instructions","index":0,"n_rows":64,"n_cols":2,"rows_kept":64,"cut":false,"hidden":false,"merged":[[0,1,0,12],[63,1,63,5],[1,1,1,12],[2,1,27,12],[36,1,61,12],[29,1,30,12]]}
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[null,"GENERAL INSTRUCTIONS\n"]
[null,"\nWHAT TO AUDIT:\n\n• RCOs must conduct regulatory audits using ORO's research safety regulatory audit tool (or equivalent) for all protocols approved by the Subcommittee on Research Safety (SRS). An initial safety regulatory audit must be conducted within 3 years of the Research and Development Committee (R&DC) approval date. Subsequent research safety regulatory audits should occur within 3 years of the previous research safety regulatory audit. Some protocols involving research hazards may be monitored by other research oversight committees (e.g., IACUC and/or the IRB).  \n\n• This audit tool may be combined with other relevant tools so that data common to both forms is only recorded once.  \n\n• All actions of the SRS should be reviewed retrospectively from the date of the audit to the date of the most recent approval.\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.  "]
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[null,"The instructions continue below. "]
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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. Some RCOs have found this information useful for auditing, but it is not collected by ORO.  \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. \n"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Administrative Information","index":1,"n_rows":41,"n_cols":12,"rows_kept":41,"cut":false,"hidden":false,"merged":[[33,1,37,13],[28,2,28,5],[26,2,26,5],[29,6,29,7],[41,1,60,13],[40,1,40,13],[25,6,25,7],[30,6,30,7],[28,8,28,11],[28,12,28,13],[29,8,30,11],[25,8,25,11],[28,6,28,7],[25,12,25,13],[26,6,26,7],[26,8,26,11],[27,8,27,11],[26,12,26,13],[27,12,27,13],[29,12,29,13],[24,2,25,5],[23,2,23,5],[23,6,23,7],[23,8,23,12],[18,8,20,13],[19,2,19,5],[19,6,19,7],[18,2,18,5],[18,6,18,7],[22,2,22,5],[22,6,22,7],[22,8,22,12],[21,8,21,12],[20,2,20,5],[21,2,21,5],[24,6,24,7],[11,2,11,4],[14,11,14,12],[9,2,9,4],[15,11,15,13],[9,5,9,13],[14,8,14,9],[6,1,6,13],[7,2,7,4],[7,5,7,13],[8,2,8,4],[10,2,10,4],[20,6,20,7],[21,6,21,7],[8,5,8,13],[10,5,10,13],[11,5,11,13],[1,1,1,13],[2,2,2,4],[2,5,2,13],[3,2,3,4],[3,5,3,13],[4,5,4,6],[38,1,38,5],[13,5,13,8],[13,10,13,11],[13,12,13,13],[17,1,17,13],[29,2,30,5],[27,2,27,5],[27,6,27,7],[12,2,12,4],[13,1,13,4],[14,2,14,4],[15,1,15,4],[15,5,15,9],[14,5,14,6],[4,2,4,4]]}
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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 (or VA-leased space):",null,null,null,null,"Off-Site (non-leased) Location:"]
[null,null,null,null,null,"ORD-Approved Waiver for Off-Site Research:",null,null,null,null,"Specify Off-Site:"]
[null,"10.","Study Type(s):",null,null,"Animal:",null,null,"Human:",null,null,"Bench Only:"]
[null,null,null,null,null,"Umbrella Protocol that Covers Multiple Projects:"]
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[null,"KEY PROTOCOL DATES"]
[null,"11.","Is this the First Audit for this Protocol:"]
[null,"12.","Date of Prior Audit:"]
[null,"13.","Initial Approvals Reviewed Previous Audit:"]
[null,"14.","Date Protocol Initial Approval by SRS:",null,null,null,null,null,"SRS Approval Prior to Research:"]
[null,"15.","Date Protocol  First Approved by R&DC:",null,null,null,null,null,"R&DC Approval Prior to Research:"]
[null,"16.","Date of ACOS/R Letter:",null,null,null,null,null,"ACOS/R Letter Prior to Research:"]
[null,"17.","PI Notified in Writing of the Outcome of the Initial SRS Review:"]
[null,null,null,null,null,null,null,null,"Date of PI Notification of SRS Outcome:"]
[null,"18.","IRB Approval, if Required:",null,null,null,null,null,"Date of IRB Approval:"]
[null,"19.","IACUC Approval, if Required:",null,null,null,null,null,"Date of IACUC Approval:"]
[null,"20.","IBC Approval, if Required:",null,null,null,null,null,"Date of IBC Approval:"]
[null,"21.","Completed Research Protocol Safety Survey (Form 10-0398):",null,null,null,null,null,"If \"No\" Safety Survey, What Form was Used:"]
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[null,"NOTE: If a research safety protocol is opened and closed without any research activities involving hazards being initiated, completing the audit tool to this point satisfies the requirement for the safety regulatory audit."]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]
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[null,"NOTES"]

{"sheet":"Safety Protocol","index":2,"n_rows":70,"n_cols":10,"rows_kept":70,"cut":false,"hidden":false,"merged":[[57,9,57,13],[59,9,59,13],[48,1,48,13],[49,1,49,7],[49,9,49,13],[55,1,55,13],[56,1,56,7],[50,2,50,7],[50,9,50,13],[51,9,51,13],[5,1,6,1],[5,2,6,7],[14,2,14,7],[15,2,15,7],[5,9,5,13],[11,9,11,13],[12,8,13,8],[17,8,18,8],[4,2,4,7],[4,9,4,13],[15,9,15,13],[14,9,14,13],[2,1,2,13],[37,2,38,7],[39,2,40,7],[36,1,36,7],[36,9,36,13],[16,2,18,7],[25,2,25,7],[21,1,21,13],[22,1,22,7],[22,9,22,13],[9,1,9,13],[10,1,10,7],[10,9,10,13],[11,2,13,7],[3,1,3,7],[3,9,3,13],[69,1,69,13],[70,1,95,13],[41,2,42,7],[43,2,43,7],[59,2,60,7],[57,2,58,7],[67,1,67,13],[65,1,65,13],[56,9,56,13],[53,1,53,13],[64,1,64,13],[61,1,61,13],[51,2,52,7],[46,1,46,13],[43,9,43,13],[44,2,45,7],[62,1,62,5],[16,9,16,13],[23,9,23,13],[37,9,37,13],[39,9,39,13],[41,9,41,13],[19,1,19,13],[27,1,28,13],[31,1,31,13],[35,1,35,13],[23,2,24,7],[26,1,26,13],[29,1,29,13],[30,1,30,13],[25,9,25,13],[44,9,44,13]]}
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[null,"REVIEWS"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"1.","Did the protocol receive the required annual review?"]
[null,"2.","Did review of the PI's VA laboratory program by the SRS occur annually?"]
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[null,"BIOLOGICAL HAZARDS "]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"3.","Does this protocol involve the use of Biological  Hazards (microbiological or viral agents, pathogens, toxins, select agents, or animals)?"]
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[null,"4.","Is the biosafety containment level clearly stated in the protocol?"]
[null,"5.","Indicate the biosafety containment level."]
[null,"6.","Has the investigator specified precautions to be taken for specific hazards (e.g., personal protective equipment to be used, work in a biological safety cabinet)?"]
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[null,"HUMAN OR NON-HUMAN CELL OR TISSUE SAMPLES"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"7.","Does this protocol involve the use of human or non-human cell or tissue samples?"]
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[null,"8.","Will this use represent a potential biohazard for lab personnel?"]
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[null,"The tool continues below. "]
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[null,"NON-EXEMPT RECOMBINANT OR SYNTHETIC NUCLEIC ACID  MOLECULES"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"9.","Does this protocol involve the use of non-exempt recombinant or synthetic nucleic acid molecules?"]
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[null,"10.","If required, has the protocol been approved by an Institutional Biosafety Committee (IBC)?"]
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[null,"11.","Was the investigator appropriately notified in writing or electronically of the outcome of the IBC's review?"]
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[null,"12.","Enter the date the investigator was notified of the outcome."]
[null,"13.","Did the protocol receive appropriate periodic review (as determined by the IBC or other local policy)?"]
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[null,"CHEMICAL HAZARDS"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"14.","Does this protocol involve chemical hazards?"]
[null,"15.","Was the laboratory chemical inventory reviewed semi-annually as required by VHA policy?"]
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[null,"RADIOISOTOPES OR RADIATION"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"16.","Does this protocol involve radioisotopes or a radiation source?"]
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[null,"17.","Has the protocol been reviewed by the Radiation Safety Committee?"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]
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[null,"NOTES: SAFETY PROTOCOL"]

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

{"sheet":"SRS Protocol Actions","index":4,"n_rows":31,"n_cols":9,"rows_kept":31,"cut":false,"hidden":false,"merged":[[1,1,2,12],[3,8,6,12],[7,8,7,12],[8,8,8,12],[9,8,9,12],[10,8,10,12],[3,1,6,3],[5,6,6,6],[5,7,6,7],[3,6,4,7],[3,4,4,5],[5,4,6,4],[5,5,6,5],[11,1,11,3],[18,1,18,3],[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],[25,8,25,12],[26,8,26,12],[22,1,22,3],[19,1,19,3],[20,1,20,3],[21,1,21,3],[21,8,21,12],[22,8,22,12],[11,8,11,12],[12,8,12,12],[13,8,13,12],[14,8,14,12],[15,8,15,12],[30,1,30,5],[16,8,16,12],[17,8,17,12],[18,8,18,12],[19,8,19,12],[20,8,20,12],[28,1,28,3],[27,1,27,3],[27,8,27,12],[28,8,28,12],[26,1,26,3],[23,1,23,3],[24,1,24,3],[25,1,25,3],[23,8,23,12],[24,8,24,12]]}
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[null,"SRS SUBMISSIONS, APPROVALS, AND OTHER ACTIONS"]
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[null,"1. Protocol Amendments, Continuing Review Approval, etc.",null,null,"2. SRS 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":"IBC Protocol Actions","index":5,"n_rows":31,"n_cols":9,"rows_kept":31,"cut":false,"hidden":false,"merged":[[1,1,2,12],[3,8,6,12],[3,6,4,7],[5,4,6,4],[5,5,6,5],[5,6,6,6],[5,7,6,7],[8,1,8,3],[9,1,9,3],[10,1,10,3],[3,1,6,3],[3,4,4,5],[7,1,7,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[12,8,12,12],[13,8,13,12],[14,1,14,3],[15,1,15,3],[16,1,16,3],[14,8,14,12],[15,8,15,12],[16,8,16,12],[17,1,17,3],[18,1,18,3],[19,1,19,3],[17,8,17,12],[18,8,18,12],[19,8,19,12],[24,8,24,12],[25,8,25,12],[20,1,20,3],[21,1,21,3],[22,1,22,3],[20,8,20,12],[21,8,21,12],[22,8,22,12],[30,1,30,5],[7,8,7,12],[8,8,8,12],[9,8,9,12],[10,8,10,12],[11,8,11,12],[27,1,27,3],[28,1,28,3],[26,1,26,3],[26,8,26,12],[27,8,27,12],[28,8,28,12],[23,1,23,3],[24,1,24,3],[25,1,25,3],[23,8,23,12]]}
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[null,"IBC SUBMISSIONS, APPROVALS, AND OTHER ACTIONS"]
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[null,"1. Protocol Amendments, Continuing Review Approval, etc.",null,null,"2. IBC 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":6,"n_rows":23,"n_cols":10,"rows_kept":23,"cut":false,"hidden":false,"merged":[[13,6,13,8],[14,6,14,8],[12,9,12,13],[14,1,14,5],[15,1,15,5],[13,1,13,5],[13,9,13,13],[16,1,16,5],[17,1,17,5],[14,9,14,13],[17,9,17,13],[16,6,16,8],[15,9,15,13],[15,6,15,8],[17,6,17,8],[16,9,16,13],[22,1,22,13],[23,1,32,13],[18,1,18,5],[19,1,19,5],[19,9,19,13],[18,6,18,8],[19,6,19,8],[18,9,18,13],[1,1,1,13],[5,1,5,5],[6,1,6,5],[7,9,7,13],[6,9,6,13],[2,1,4,13],[8,9,8,13],[5,9,5,13],[7,1,7,5],[8,1,8,5],[5,6,5,8],[6,6,6,8],[7,6,7,8],[8,6,8,8],[10,9,10,13],[11,9,11,13],[10,6,10,8],[12,1,12,5],[9,1,9,5],[9,6,9,8],[10,1,10,5],[11,6,11,8],[12,6,12,8],[11,1,11,5],[9,9,9,13]]}
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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,null,"Date / Version",null,null,"Comments"]
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[null,"NOTES"]

{"sheet":"Item Specific Instructions","index":7,"n_rows":248,"n_cols":13,"rows_kept":248,"cut":false,"hidden":false,"merged":[[234,1,234,12],[241,1,246,11],[247,1,251,11],[211,1,211,12],[218,1,223,11],[224,1,228,11],[212,1,217,11],[235,1,240,11],[177,1,180,11],[181,1,187,11],[201,1,208,11],[188,1,191,11],[200,1,200,12],[144,1,146,11],[147,1,151,11],[167,1,167,12],[168,1,176,11],[114,1,116,11],[117,1,119,11],[120,1,121,11],[122,1,124,11],[135,1,137,11],[138,1,141,11],[68,1,68,12],[101,1,101,12],[134,1,134,12],[143,1,143,12],[86,1,86,12],[69,1,74,11],[109,1,109,12],[102,1,105,11],[106,1,107,11],[110,1,113,11],[75,1,84,11],[87,1,89,11],[90,1,91,11],[92,1,93,11],[94,1,95,11],[60,1,62,11],[22,1,25,11],[26,1,30,11],[35,1,35,12],[36,1,37,11],[48,1,50,11],[51,1,53,11],[54,1,55,11],[56,1,57,11],[58,1,59,11],[1,1,1,12],[9,1,9,12],[2,1,3,11],[4,1,5,11],[45,1,47,11],[40,1,41,11],[42,1,44,11],[38,1,39,11],[20,1,21,11],[17,1,19,11],[15,1,16,11],[6,1,7,11],[10,1,11,11],[12,1,14,11]]}
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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.",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).",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.",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.\"",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 for the protocol. 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. Off-site research that is also VA-funded must have an Office of Research and Development (ORD)-approved waiver. If the PI or Research Service has any questions related to whether a full or partial off-site waiver is applicable they should contact the applicable ORD funding service.\n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"10. Study Type: Indicate the type of protocol being audited. Select \"Bench Only\" if the protocol does not include animal or human subject hazards (e.g., the research considered bench, basic science, wet-lab, safety-science, etc.). For umbrella protocols, audit each umbrella protocol every 3 years, which basically amounts to auditing the lab or the PI. Studies under the umbrella protocol can be included separately in the \"DOCUMENT MANAGEMENT SUMMARY\" section. For the FDC, document each umbrella protocol as one protocol. \t\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,"11. First Audit: Indicate whether this is the first safety regulatory audit conducted for this protocol.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"12. Date of Prior Audit: If this is not the first safety regulatory audit conducted for this protocol, indicate the date of the last audit. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"13. Initial Approvals Reviewed in Previous Audit: Indicate whether the initial approvals were reviewed as part of a previous safety audit. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"14. SRS Approval: Indicate the date the protocol received initial 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"]
[]
[]
[null,"15. 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,"16. 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"]
[]
[]
[null,"17. Notification in Writing: Indicate whether the PI was notified of the outcome of the SRS review in writing and the date of that notification. [See 1200.08(1)6.e(3).]",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[]
[null,"18. IRB Review: Indicate whether IRB review and approval were obtained, if required.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"19. IACUC Review: Indicate whether IACUC review and approval were obtained, if required.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"20. IBC Review: Indicate whether IBC review and approval were obtained, if required. Indicate the date of IBC approval, if applicable.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"21. Research Protocol Safety Survey: Indicate whether the research protocol safety survey (Form 10-0398) was completed. If not completed, indicate what form was used.  ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
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[null,"INSTRUCTIONS AND GUIDANCE: PROTOCOL REVIEWS"]
[null,"1. Annual Review: Indicate whether the protocol received an annual review. Enter \"N/A\" if the audit date is before the 1-year anniversary. VHA Directive 1200.08(1) does not explicitly state that an annual review of a protocol must occur. However, VHA Directive 1200.08(1) §6.e(4) states “When the SRS grants approval, it must specify the duration (up to one year from the date of approval) that the approval is valid.” Subsequent protocol continuing reviews are not required by VHA policy. The RCO should verify that the SRS re-approved the protocol after the initial review within one year but does not have to verify any subsequent continuing reviews.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"2. Review of PI's VA Laboratory: Indicate whether the SRS conducted a review of the PI's VA laboratory program annually. [VHA Directive 1200.08(1) §6.f(1).] Each PI’s VA laboratory program must be reviewed by the SRS at a convened meeting on an annual basis. The review must include: (a) A list of projects that utilize SRS approved protocols; (b) An evaluation of all SRS approved protocols (individual or umbrella) to ensure that the hazards, BSL, risk assessments, training of personnel and status of the project are up to date; (c) Laboratory inspection report including findings and plans to address any deficiencies; (d) Summary of all changes or amendments to the safety components of the protocol approved since the last review; (e) Changes in space allocation; and (f) Reports of any issues related to employee safety and security. If the protocol being audited is an umbrella protocol, RCOs should verify that an annual review of the PI’s laboratory was conducted by the SRS. If the protocol being audited is an individual protocol (i.e., not an umbrella protocol), RCOs should verify that the PI’s laboratory in which the protocol took place had an annual review conducted by the SRS.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: BIOLOGICAL HAZARDS"]
[null,"3. Biological Hazards: Indicate whether the protocol involves the use of Biological Hazards, as defined in Title 42 Code of Federal Regulations (CFR) §72.6.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[]
[null,"4. Biosafety Containment Level Stated: Indicate whether the biosafety containment level is clearly stated in the protocol.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"5. Biosafety Containment Level: Indicate the biosafety containment level.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"6. Precautions for Specific Hazards: Indicate whether the precautions to be taken for specific hazards are specified. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: HUMAN OR NON-HUMAN CELL OR TISSUE SAMPLES"]
[null,"7. Human or Non-Human Cell or Tissue Samples: Indicate whether the protocol involves the use of human or non-human cell or tissue samples. This includes cultures, tissues, blood, other bodily fluids or cell lines. Information on cells and tissue samples used by the laboratory is found in the RPSS, Section 4.\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"8. Potential Biohazard: Indicate whether the use of tissue will represent a potential biohazard for lab personnel.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[]
[null,"INSTRUCTIONS AND GUIDANCE: NON-EXEMPT RECOMBINANT OR SYNTHETIC NUCLEIC ACID  MOLECULES"]
[null,"9. Non-Exempt Recombinant or Synthetic Nucleic Acid Molecules: Indicate whether the protocol involves the use of non-exempt recombinant or synthetic nucleic acid molecules. Information on recombinant DNA used by the laboratory is found in the RPSS, Section 5 and, for animal research, in ACORP Appendix 3 Section 8. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"10. IBC Approval: Indicate whether the protocol has been approved by an IBC. This question overlaps with the administrative information tab. Please ensure consistency between the two. \n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"11. Investigator Notification: Indicate whether the investigator was notified in writing or electronically of the outcome of the IBC's review. See VHA Directive 1200.08(1)§5.o(4).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"12. Date of Notification: Indicate the date the investigator was notified of the outcome of the IBC's review, if applicable.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"13. Periodic Review: Indicate whether the protocol received appropriate periodic review as determined by the IBC or other local policy. See VHA Directive 1200.08(1)§5.o(2).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
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[null,"INSTRUCTIONS AND GUIDANCE: CHEMICAL HAZARDS"]
[null,"14. Chemical Hazards: Indicate whether the protocol involves any chemical hazards. Information on the inventory of chemicals used by the laboratory is found in the RPSS, Section 6.    ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"15. Chemical Inventory Review: Indicate whether the laboratory chemical inventory was reviewed semi-annually as required by VHA policy. VHA Directive 1200.08(1)§5.h(1). Ensuring that inventories of all chemicals in each local VA research laboratory are maintained by the PI and reviewed at least semi-annually so that appropriate security measures can be implemented.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: RADIOISOTOPES OR RADIATION"]
[null,"16. Radioisotopes or Radiation: Indicate whether the protocol involves research-specific radioisotopes or a research-specific radiation source. Information on the use of radioactive materials by the laboratory is found in the RPSS, Section 8.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"17. Radiation Safety Committee Review: Indicate whether the protocol has been reviewed by the Radiation Safety Committee. VHA Directive 1105 §5.h(1). Ensuring that research protocols requiring the use of ionizing radiation are reviewed by the VA medical facility Radiation Safety Committee and other appropriate committees and subcommittees (e.g., Research and Development Committee, Institutional Review Board, Institutional Animal Care and Use Subcommittee, Subcommittee on Research Safety).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: STAFF TRAINING"]
[null,"The Research Service at each facility must develop and maintain a system to verify that all research personnel have completed local training requirements commensurate with relevant hazards and duties assigned. Local SOPs should describe the system used to maintain research-specific training records, the location of records, and the individual(s) who are responsible. Safety training requirements will be specific to the activities for each research program. Common safety training courses that may be required for research personnel are chemical hygiene plan, bloodborne pathogens, respiratory protection, formaldehyde awareness training (may be included in the chemical hygiene plan training or a separate course). RCOs should look at RPSS forms to determine potential hazards, staff listing, scopes of practice (form identifies activities, e.g., blood draws, handling human specimens, use of chemicals), and chemical inventory to identify formaldehyde / formalin / paraformaldehyde use. ",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 Safety 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. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"3. Training Ever Completed: If training 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: STAFF TRAINING (continued)"]
[null,"4. Bloodborne Pathogen Training: Human blood includes: human blood components and products made from human blood. Other Potentially Infectious Materials means: (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. Definitions per 29 CFR 1910.1030.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: SRS PROTOCOL ACTIONS"]
[null,"RCOs should review the protocol file, including the protocol and all SRS actions since initial approval or the last audit. This tab can be used to document the protocol history, including substantive actions of the SRS related to the audited protocol in chronological order. RCOs should note any possible compliance issues related to SRS 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. SRS Dates: The date should be verified for every SRS 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 SRS action was anything other than approval, make a note in the \"Comments.\" The date of Research and Development Committee (R&DC) approval of SRS 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 SRS, 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"]
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[null,"INSTRUCTIONS AND GUIDANCE: IBC PROTOCOL ACTIONS"]
[null,"RCOs should review the protocol file, including the protocol and all IBC actions since initial approval or the last audit. This tab can be used to document the protocol history, including substantive actions of the IBC related to the audited protocol in chronological order. RCOs should note any possible compliance issues related to IBC 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. IBC Dates: The date should be verified for every IBC action. This will allow the auditor 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 by the auditor. If the IBC action was anything other than approval, make a note in the \"Comments\" section. The date of R&DC approval of IBC 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 IBC, 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":8,"n_rows":4,"n_cols":4,"rows_kept":4,"cut":false,"hidden":true,"merged":[]}
[]
["Yes","Open","PI","BSL 1"]
["No","Closed","SC","BSL 2"]
["N/A",null,"SI","BSL 3"]