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{"sheet":"General Instructions","index":0,"n_rows":64,"n_cols":2,"rows_kept":64,"cut":false,"hidden":false,"merged":[[63,1,63,5],[2,1,2,12],[3,1,25,12],[28,1,29,12],[35,1,61,12]]}
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[null,"GENERAL INSTRUCTIONS\n"]
[null,"WHAT TO AUDIT:\n• RCOs must conduct regulatory audits using ORO's HRP audit tool (or equivalent) for all human subjects research studies (i.e., both exempt and non-exempt). An initial HRP regulatory audit must be conducted within 3 years of the R&DC approval date. Subsequent HRP regulatory audits must occur within 3 years of the previous HRP regulatory audit. \n\n• Certain protocols involving human subjects may have safety concerns as well. If the protocol is also overseen by the Subcommittee on Research Safety (SRS), a safety audit must also be conducted on the protocol. RCOs may elect to perform the safety audit in combination with the HRP audit for efficiency. Examples of protocols involving human subjects that may have safety concerns requiring review by the SRS include any research use outside of normal clinical settings of hazardous chemicals, radioactive materials, controlled substances, and/or blood products.    \n\n• HRP 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"]
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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 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 HRP 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":"Protocol Info and Approvals","index":1,"n_rows":99,"n_cols":12,"rows_kept":99,"cut":false,"hidden":false,"merged":[[44,2,44,7],[44,9,44,13],[88,1,88,5],[46,9,46,13],[50,9,50,13],[52,9,52,13],[69,9,69,13],[72,9,72,13],[77,9,77,13],[79,9,79,13],[81,9,81,13],[70,9,70,13],[47,9,47,13],[51,9,51,13],[53,9,53,13],[69,2,70,7],[72,2,73,7],[65,1,65,13],[57,2,57,7],[58,2,58,7],[59,2,59,7],[61,2,61,7],[49,2,49,7],[49,9,49,13],[99,1,121,13],[84,1,87,13],[5,2,5,4],[5,5,5,9],[5,10,5,13],[6,5,6,9],[9,5,9,13],[18,6,18,13],[20,5,20,6],[20,11,20,12],[20,8,20,9],[6,2,6,4],[18,2,18,4],[11,2,11,4],[17,2,17,4],[13,2,13,4],[14,2,14,4],[13,10,13,12],[13,5,13,8],[14,10,14,12],[40,8,40,12],[39,6,39,7],[39,8,39,12],[40,2,40,5],[40,6,40,7],[22,2,22,4],[21,5,21,6],[21,7,21,13],[38,6,38,7],[38,8,38,12],[35,2,35,5],[35,6,35,7],[35,8,35,13],[23,8,23,9],[23,11,23,12],[23,5,23,6],[33,1,33,13],[37,2,37,5],[37,6,37,7],[37,8,37,12],[22,8,22,9],[21,1,21,4],[34,8,34,13],[36,6,36,7],[36,8,36,12],[23,2,23,4],[20,2,20,4],[19,2,19,4],[34,6,34,7],[38,2,38,5],[2,1,2,13],[3,2,3,4],[3,5,3,13],[4,2,4,4],[4,5,4,13],[15,5,15,8],[16,5,16,8],[10,5,10,13],[12,5,12,13],[8,1,8,13],[9,2,9,4],[10,2,10,4],[12,2,12,4],[14,5,14,8],[16,10,16,13],[15,1,16,4],[11,5,11,13],[15,10,15,12],[27,1,27,13],[19,5,19,13],[48,9,48,13],[45,9,45,13],[77,2,78,7],[81,2,82,7],[79,2,80,7],[59,11,59,13],[67,9,67,13],[60,11,60,13],[61,11,61,13],[60,2,60,7],[55,1,55,13],[56,1,56,7],[46,2,47,7],[66,9,66,13],[67,2,67,7],[68,2,68,7],[68,9,68,13],[71,2,71,7],[71,9,71,13],[58,11,58,13],[52,2,53,7],[57,11,57,13],[98,1,98,13],[17,5,17,9],[17,10,17,13],[22,10,22,13],[22,5,22,7],[56,11,56,13],[39,2,39,5],[24,5,24,6],[25,2,25,4],[25,6,25,13],[66,1,66,7],[42,1,42,13],[45,2,45,7],[43,1,43,7],[24,8,24,9],[34,2,34,5],[36,2,36,5],[24,11,24,12],[43,9,43,13],[75,1,75,13],[76,1,76,7],[76,9,76,13],[50,2,51,7],[48,2,48,7]]}
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[null,"AUDIT INFORMATION"]
[null,"1.","Date of Current Audit:"]
[null,"2.","Auditor(s):"]
[null,"3.","Current Status:"]
[null,null,"Date of Closure/Termination:"]
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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.","Protocol Subject To:",null,null,"Pre-2018 Common Rule:",null,null,null,null,"2018 Common Rule:"]
[null,"9.","Review Level:",null,null,"Exempt:",null,null,null,null,"Exemption Category(ies):"]
[null,null,null,null,null,"Expedited Review:",null,null,null,null,"Expedited Review Category(ies):"]
[null,null,null,null,null,"Convened IRB Review:"]
[null,"10.","Risk Level:"]
[null,"11.","FDA Regulated:"]
[null,"12.","Sponsor / Source of Funding:"]
[null,"13.","Study Site(s):",null,null,"VA Facility:",null,null,"Academic Affiliate:",null,null,"Other:"]
[null,null,null,null,null,"List Other:"]
[null,"14.","IRB of Record:",null,null,null,null,null,"List Other:"]
[null,"15.","Study Components:",null,null,"International Study:",null,null,"Children:",null,null,"Prisoners:"]
[null,null,null,null,null,"MFD Approval on File:",null,null,"MFD Approval on File:",null,null,"CRADO Approval on File:"]
[null,"16.","Data Repository:"]
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[null,"The tool continues below. "]
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[null,"KEY PROTOCOL DATES"]
[null,"17.","Initial Approvals Reviewed Previous Audit:"]
[null,"18.","Date of Exemption Determination Review:"]
[null,"19.","Date Protocol First Approved by IRB:",null,null,null,null,null,"IRB Approval Prior to Research:"]
[null,"20.","Date of Final PO Review:",null,null,null,null,null,"Final PO Review Prior to Final R&DC Approval:"]
[null,"21.","Date of ISSO Review:",null,null,null,null,null,"ISSO Review Prior to Final R&DC Approval:"]
[null,"22.","Date Protocol  First Approved by R&DC:",null,null,null,null,null,"R&DC Approval Prior to Research:"]
[null,"23.","Date of ACOS/R Letter:",null,null,null,null,null,"ACOS/R Letter Prior to Research:"]
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[null,"EXEMPT PROTOCOLS (2018 Common Rule)"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"24.","Were the exempt audit elements reviewed in a previous audit?"]
[null,"25.","Was the exempt category determination documented?"]
[null,"26.","Does the exempt category determination appear to match the regulatory description of the category?"]
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[null,"27.","Did the protocol REQUIRE a limited IRB review?"]
[null,"28.","Did the protocol RECEIVE a required limited IRB review?"]
[null,"29.","Does the exempt study involve direct interaction with human subjects?"]
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[null,"30.","Do the study documents include provisions for giving subjects the information outlined in VHA Directive 1200.05(3)§10.c?"]
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[null,"IRB CONTINUING REVIEW"]
[null,"Audit Element (Indicate \"Yes\" or \"No\" for each year reviewed.)",null,null,null,null,null,null,"Year 1","Year 2","Year 3","Comments"]
[null,"31.","Is Continuing Review (CR) required by VHA Directive 1200.05?"]
[null,"32.","If CR is NOT required by 1200.05, did the IRB require CR?"]
[null,"33.","Was the rationale for requiring CR documented?"]
[null,"34.","Did CR occur as scheduled?"]
[null,"35.","Did any research occur during the lapse in approval?"]
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[null,"SINGLE IRB REVIEW"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"36.","Is the protocol subject to the single IRB review requirement?"]
[null,"37.","Was the study reviewed by a single IRB?"]
[null,"38.","Was a valid exception granted by ORD or another Federal entity supporting the research?"]
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[null,"39.","Was the reviewing single IRB external to the VA medical facility?"]
[null,"40.","Was a valid reliance agreement in place for the VA medical facility to rely on that external IRB?"]
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[null,"INVESTIGATIONAL DRUGS"]
[null,"Audit Element",null,null,null,null,null,null,"Response","Comments"]
[null,"41.","Does the protocol involve investigational drugs?"]
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[null,"42.","Does the investigational drug log or accountability record contain the required elements? "]
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[null,"43.","Are investigational drugs stored separately from regular pharmacy stock?"]
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[null,"NOTE: If a human protocol is opened and closed without enrolling human subjects or accessing any records or data at this site, completing the audit tool to this point satisfies the requirement for the HRP regulatory audit. "]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]
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[null,"NOTES"]

{"sheet":"Protocol Actions","index":2,"n_rows":30,"n_cols":9,"rows_kept":30,"cut":false,"hidden":false,"merged":[[1,1,2,12],[3,8,6,12],[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],[10,1,10,3],[7,1,7,3],[8,1,8,3],[9,1,9,3],[7,8,7,12],[8,8,8,12],[9,8,9,12],[10,8,10,12],[13,1,13,3],[14,1,14,3],[11,1,11,3],[12,1,12,3],[11,8,11,12],[12,8,12,12],[13,8,13,12],[14,8,14,12],[17,1,17,3],[18,1,18,3],[15,1,15,3],[16,1,16,3],[15,8,15,12],[16,8,16,12],[17,8,17,12],[18,8,18,12],[19,1,19,3],[20,1,20,3],[21,1,21,3],[19,8,19,12],[20,8,20,12],[21,8,21,12],[23,1,23,3],[24,1,24,3],[23,8,23,12],[24,8,24,12],[22,1,22,3],[22,8,22,12],[29,1,29,5],[27,1,27,3],[25,1,25,3],[26,1,26,3],[25,8,25,12],[26,8,26,12],[27,8,27,12]]}
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[null,"RESEARCH REVIEW COMMITTEE (RRC) SUBMISSIONS, APPROVALS, AND OTHER ACTIONS"]
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[null,"1. Protocol Amendments, Continuing Review Approval, etc.",null,null,"2. RRC 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":"Informed Consent","index":3,"n_rows":30,"n_cols":10,"rows_kept":30,"cut":false,"hidden":false,"merged":[[9,9,9,13],[10,9,10,13],[3,1,6,3],[7,1,7,3],[8,1,8,3],[1,1,2,13],[11,1,11,3],[7,6,7,7],[8,6,8,7],[9,6,9,7],[10,6,10,7],[3,5,6,5],[3,4,6,4],[3,8,6,8],[3,6,6,7],[9,1,9,3],[3,9,6,13],[7,9,7,13],[10,1,10,3],[11,9,11,13],[8,9,8,13],[12,9,12,13],[13,9,13,13],[14,9,14,13],[11,6,11,7],[15,1,15,3],[13,1,13,3],[14,1,14,3],[13,6,13,7],[14,6,14,7],[12,6,12,7],[12,1,12,3],[16,1,16,3],[15,6,15,7],[16,6,16,7],[15,9,15,13],[16,9,16,13],[19,9,19,13],[17,1,17,3],[18,1,18,3],[17,6,17,7],[18,6,18,7],[17,9,17,13],[18,9,18,13],[21,6,21,7],[22,1,22,3],[23,1,23,3],[19,1,19,3],[19,6,19,7],[20,9,20,13],[21,9,21,13],[22,9,22,13],[23,9,23,13],[26,1,26,3],[24,1,24,3],[25,1,25,3],[24,6,24,7],[25,6,25,7],[24,9,24,13],[25,9,25,13],[22,6,22,7],[23,6,23,7],[20,1,20,3],[21,1,21,3],[20,6,20,7],[29,1,29,5],[27,1,27,3],[26,6,26,7],[27,6,27,7],[26,9,26,13],[27,9,27,13]]}
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[null,"INFORMED CONSENT RELATED IRB SUBMISSIONS, APPROVALS, AND OTHER ACTIONS"]
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[null,"1. Informed Consent \nVersion Date",null,null,"2. IC Version Number","3. Date of IRB Approval","4. Reason for Revision",null,"5. Re-Consent Required?","6. Comments"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"UPIRTSO Reporting","index":4,"n_rows":31,"n_cols":14,"rows_kept":31,"cut":false,"hidden":false,"merged":[[1,1,2,13],[20,4,20,6],[3,1,6,1],[3,2,6,2],[3,3,6,3],[11,4,11,6],[3,9,6,9],[3,13,6,13],[3,10,3,12],[4,10,6,10],[3,4,6,6],[3,7,6,7],[18,4,18,6],[4,12,6,12],[7,4,7,6],[8,4,8,6],[30,1,30,5],[28,4,28,6],[14,4,14,6],[15,4,15,6],[16,4,16,6],[24,4,24,6],[25,4,25,6],[26,4,26,6],[27,4,27,6],[23,4,23,6],[19,4,19,6],[17,4,17,6],[21,4,21,6],[22,4,22,6],[9,4,9,6],[13,4,13,6],[10,4,10,6],[4,11,6,11],[3,8,6,8],[12,4,12,6]]}
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[null,"\nLOCAL APPARENT UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPIRTSOS)\n"]
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[null,"1. Date Event Occurred","2. Date Learned of Event","3. Subject ID","4. Event Description",null,null,"5. Date Reported to RRC","6. Reported on Time ","7. Reviewed on Time","Categorized by IRB",null,null,"11. Reported to ORO"]
[null,null,null,null,null,null,null,null,null,null,"8. Unanticipated","9. Related / Possibly Related","10. Increased Risk"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"Staff Training","index":5,"n_rows":30,"n_cols":12,"rows_kept":30,"cut":false,"hidden":false,"merged":[[7,4,7,5],[20,4,20,5],[20,6,20,7],[19,6,19,7],[18,6,18,7],[17,6,17,7],[17,1,17,3],[18,1,18,3],[19,1,19,3],[20,1,20,3],[19,4,19,5],[17,4,17,5],[16,4,16,5],[1,1,2,13],[3,8,6,8],[3,6,6,7],[3,4,6,5],[3,1,6,3],[8,6,8,7],[16,1,16,3],[7,1,7,3],[7,6,7,7],[14,6,14,7],[13,6,13,7],[12,6,12,7],[11,6,11,7],[10,6,10,7],[9,6,9,7],[16,6,16,7],[15,6,15,7],[15,1,15,3],[9,1,9,3],[8,1,8,3],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[26,1,26,3],[27,1,27,3],[8,4,8,5],[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],[23,1,23,3],[24,1,24,3],[25,1,25,3],[14,1,14,3],[26,4,26,5],[27,4,27,5],[24,4,24,5],[25,4,25,5],[21,1,21,3],[22,1,22,3],[22,4,22,5],[23,4,23,5],[21,4,21,5],[18,4,18,5],[27,11,27,13],[14,9,14,10],[15,9,15,10],[16,9,16,10],[17,9,17,10],[18,9,18,10],[19,9,19,10],[23,9,23,10],[24,6,24,7],[23,6,23,7],[22,6,22,7],[21,6,21,7],[26,6,26,7],[25,6,25,7],[20,9,20,10],[21,9,21,10],[22,9,22,10],[25,11,25,13],[26,11,26,13],[3,11,6,13],[3,9,6,10],[7,9,7,10],[8,9,8,10],[9,9,9,10],[10,9,10,10],[11,9,11,10],[12,9,12,10],[13,9,13,10],[29,1,29,5],[24,9,24,10],[25,9,25,10],[26,9,26,10],[27,9,27,10],[7,11,7,13],[8,11,8,13],[9,11,9,13],[10,11,10,13],[11,11,11,13],[12,11,12,13],[13,11,13,13],[14,11,14,13],[15,11,15,13],[16,11,16,13],[17,11,17,13],[18,11,18,13],[19,11,19,13],[20,11,20,13],[21,11,21,13],[22,11,22,13],[23,11,23,13],[24,11,24,13],[27,6,27,7]]}
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[null,"STUDY STAFF TRAINING"]
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[null,"1. Site Personnel",null,null,"2. All Human Research Training Current?",null,"3. If Training Not Current, 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":"Subject Record Review","index":6,"n_rows":31,"n_cols":14,"rows_kept":31,"cut":false,"hidden":false,"merged":[[27,10,27,13],[27,8,27,9],[25,8,25,9],[26,8,26,9],[25,1,25,3],[25,4,25,5],[25,6,25,7],[25,10,25,13],[26,1,26,3],[26,4,26,5],[26,6,26,7],[26,10,26,13],[27,1,27,3],[27,4,27,5],[27,6,27,7],[28,1,28,3],[28,4,28,5],[28,6,28,7],[28,10,28,13],[28,8,28,9],[23,1,23,3],[23,4,23,5],[23,6,23,7],[23,10,23,13],[24,1,24,3],[24,4,24,5],[24,6,24,7],[24,10,24,13],[23,8,23,9],[24,8,24,9],[21,1,21,3],[21,4,21,5],[21,6,21,7],[21,10,21,13],[22,1,22,3],[22,4,22,5],[22,6,22,7],[22,10,22,13],[21,8,21,9],[22,8,22,9],[19,1,19,3],[19,4,19,5],[19,6,19,7],[19,10,19,13],[20,1,20,3],[20,4,20,5],[20,6,20,7],[20,10,20,13],[19,8,19,9],[20,8,20,9],[18,1,18,3],[18,4,18,5],[18,6,18,7],[18,10,18,13],[18,8,18,9],[15,1,15,3],[15,8,15,9],[16,8,16,9],[9,10,14,13],[17,1,17,3],[17,4,17,5],[17,6,17,7],[17,10,17,13],[17,8,17,9],[30,1,30,5],[5,1,8,13],[1,1,2,13],[15,4,15,5],[15,6,15,7],[15,10,15,13],[3,1,3,12],[4,1,4,12],[9,1,14,3],[9,4,14,5],[9,6,14,7],[9,8,14,9],[16,1,16,3],[16,4,16,5],[16,6,16,7],[16,10,16,13]]}
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[null,"SUBJECT RECORD REVIEW"]
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[null,"TOTAL NUMBER OF SUBJECTS WHO PASSED SCREENING AND WERE INCLUDED FOR ANALYSIS IN THIS PERIOD:"]
[null,"NUMBER OF SUBJECT RECORDS TO AUDIT DURING THIS REPORTING PERIOD: (Auto calculated)",null,null,null,null,null,null,null,null,null,null,null,{"$f":"_xlfn.IFS(N4<11,N4,N4<101,10,N4<301,N4*0.1,N4>300,30)","v":0}]
[null,"IF 10 OR FEWER SUBJECTS IN THIS PERIOD, AUDIT ALL OF THEM \nIF 11-100 SUBJECTS IN THIS PERIOD, AUDIT A RANDOM SAMPLE OF 10 OF THEM \nIF 101-300 SUBJECTS IN THIS PERIOD, AUDIT A RANDOM SAMPLE OF 10% OF THEM\nIF MORE THAN 300 IN THIS PERIOD, AUDIT A RANDOM SAMPLE OF 30 OF THEM "]
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[null,"1. Study Subject ID",null,null,"2. Documentation that Consent Obtained Prior to Initiation of Study Procedures",null,"3. Subject Not Meeting Inclusion or Meeting Exclusion Criteria was Included in Research \n(>minimal risk research)",null,"4. Progress Note was Present in VHA Health Record (if required)",null,"5. Specify Other Issues Found"]
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[null,"CLICK HERE TO CONTINUE TO NEXT TAB"]

{"sheet":"OPTIONAL_Audit Preparation","index":7,"n_rows":48,"n_cols":10,"rows_kept":48,"cut":false,"hidden":false,"merged":[[25,9,25,13],[15,1,15,5],[16,1,16,5],[17,1,17,5],[14,1,14,5],[10,1,10,5],[11,1,11,5],[12,1,12,5],[13,1,13,5],[22,1,22,5],[24,9,24,13],[23,9,23,13],[22,9,22,13],[21,9,21,13],[14,9,14,13],[13,9,13,13],[12,9,12,13],[20,9,20,13],[19,9,19,13],[18,9,18,13],[17,9,17,13],[16,9,16,13],[15,9,15,13],[23,1,23,5],[36,6,36,8],[44,1,44,5],[44,6,44,8],[44,9,44,13],[31,1,31,5],[32,1,32,5],[33,1,33,5],[36,1,36,5],[37,1,37,5],[40,1,40,5],[32,9,32,13],[43,6,43,8],[43,9,43,13],[42,9,42,13],[41,9,41,13],[40,9,40,13],[39,9,39,13],[37,6,37,8],[38,6,38,8],[39,6,39,8],[40,6,40,8],[41,6,41,8],[42,6,42,8],[38,9,38,13],[37,9,37,13],[36,9,36,13],[33,9,33,13],[26,9,26,13],[30,9,30,13],[29,9,29,13],[28,9,28,13],[27,9,27,13],[31,9,31,13],[24,1,24,5],[12,6,12,8],[31,6,31,8],[32,6,32,8],[33,6,33,8],[26,6,26,8],[27,6,27,8],[28,6,28,8],[29,6,29,8],[30,6,30,8],[25,1,25,5],[25,6,25,8],[28,1,28,5],[6,6,6,8],[7,6,7,8],[8,6,8,8],[9,6,9,8],[10,6,10,8],[42,1,42,5],[18,1,18,5],[19,1,19,5],[20,1,20,5],[21,1,21,5],[8,1,8,5],[9,1,9,5],[19,6,19,8],[20,6,20,8],[21,6,21,8],[22,6,22,8],[23,6,23,8],[24,6,24,8],[13,6,13,8],[14,6,14,8],[15,6,15,8],[16,6,16,8],[17,6,17,8],[18,6,18,8],[2,1,5,13],[34,6,35,8],[34,9,35,13],[47,1,47,13],[48,1,62,13],[1,1,1,13],[6,1,6,5],[7,1,7,5],[8,9,8,13],[7,9,7,13],[11,9,11,13],[10,9,10,13],[9,9,9,13],[11,6,11,8],[43,1,43,5],[38,1,38,5],[39,1,39,5],[41,1,41,5],[34,1,35,5],[29,1,29,5],[30,1,30,5],[27,1,27,5],[26,1,26,5],[6,9,6,13]]}
[]
[null,"OPTIONAL AUDIT PREPARATION TOOL"]
[null,"This optional audit preparation tool has been provided as a method for organizing your review of documents in preparation for the audit. This tab provides a list of possible documents that may be useful as sources of information to prepare for the regulatory audit and to complete the HRP audit tool. Some RCOs have given this list, customized for their facility, to research teams and have asked them to help assemble the documentation in advance in order to make the audit process more efficient."]
[]
[]
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[null,"Document Investigator Regulatory Files",null,null,null,null,"Present and Reviewed",null,null,"Comments"]
[null,"Protocols and Amendments"]
[null,"Approved Case Report Forms"]
[null,"IRB Approved Consent Forms"]
[null,"• Information Provided to Subjects"]
[null,"• HIPAA Forms"]
[null,"• Advertisements"]
[null,"• Record of Approved Consent Form Versions"]
[null,"Subject Log (current / accurate)"]
[null,"IRB Correspondence"]
[null,"IRB Submissions, Notifications, Approvals"]
[null,"Unanticipated Problems / Safety Reports"]
[null,"Investigator Brochure / VA Form 10-9012"]
[null,"R&D Correspondence"]
[null,"Notes-to-File"]
[null,"Site-Sponsor Correspondence"]
[null,"• Conference Call Minutes"]
[null,"• E-mails"]
[null,"• Newsletters"]
[null,"• Conference Calls"]
[null,"• Letters, Memos, Faxes"]
[null,"Study Site Personnel"]
[null,"• Signatures"]
[null,"• Qualifications"]
[null,"• Training"]
[null,"• Scope of Practice"]
[null,"• CVs"]
[null,"• Delegation"]
[null,"Signed Attestation or Investigator's Agreement (Sponsor, Institution, FDA)"]
[]
[null,"• Letters "]
[null,"• Memos"]
[null,"Signed PI Conflict of Interest / Disclosure Statement"]
[null,"Investigational Products (if applicable)"]
[null,"• Accountability"]
[null,"• Handling"]
[null,"• Pharmacy "]
[null,"• Elsewhere"]
[null,"Are there Local IRB requirements for record keeping?"]
[]
[]
[null,"NOTES"]

{"sheet":"Item Specific Instructions","index":8,"n_rows":375,"n_cols":13,"rows_kept":375,"cut":false,"hidden":false,"merged":[[230,1,230,12],[231,1,241,11],[269,1,274,11],[275,1,278,11],[242,1,247,11],[248,1,252,11],[263,1,263,12],[264,1,268,11],[156,1,158,11],[164,1,164,12],[198,1,204,11],[205,1,220,11],[221,1,225,11],[165,1,175,11],[180,1,180,11],[133,1,146,11],[104,1,104,11],[147,1,150,11],[151,1,152,11],[153,1,155,11],[103,1,103,11],[106,1,110,11],[111,1,115,11],[132,1,132,12],[99,1,99,12],[100,1,102,11],[116,1,119,11],[120,1,121,11],[122,1,127,11],[90,1,91,11],[45,1,47,11],[48,1,49,11],[50,1,50,11],[52,1,55,11],[66,1,66,12],[67,1,69,11],[70,1,70,11],[75,1,80,11],[82,1,85,11],[72,1,73,11],[25,1,25,11],[27,1,30,11],[36,1,37,11],[41,1,41,11],[87,1,88,11],[20,1,21,11],[16,1,16,11],[18,1,19,11],[14,1,14,11],[22,1,24,11],[1,1,1,12],[280,1,280,12],[281,1,285,11],[176,1,177,11],[182,1,185,11],[186,1,189,11],[197,1,197,12],[11,1,11,12],[35,1,35,12],[2,1,2,11],[43,1,44,11],[39,1,40,11],[4,1,4,11],[6,1,7,11],[12,1,12,11],[178,1,179,11],[301,1,311,11],[286,1,288,11],[289,1,291,11],[296,1,296,12],[297,1,300,11],[374,1,381,11],[328,1,328,12],[333,1,336,11],[337,1,343,11],[344,1,347,11],[349,1,349,12],[362,1,362,12],[350,1,358,11],[363,1,373,11],[316,1,318,11],[319,1,324,11],[312,1,313,11],[329,1,330,11],[331,1,331,11],[314,1,315,11]]}
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[null,"1. Date of Current Audit: Indicate the date the current audit was started or conducted.\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"2. Auditor: Indicate the name of the auditor.\t\t\t\t\t\t\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"3. Status at Time of Audit: Indicate the study status at the time of the current audit. If \"Closed/terminated\" is chosen, indicate the date the study was closed/terminated in the \"Date of closure/termination\" field.\t",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 the Local Site Investigator (LSI).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"5. Protocol Title: Enter the full title for the approved protocol.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"6. IRBNet Number: Enter the IRBNet number. If the protocol does not have an IRBNet number, enter \"N/A.\"\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"7. Protocol Number: Enter the protocol number or other identifier for the protocol or \"N/A\" if a separate protocol number does not exist. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"8. Common Rule Requirements: Indicate which set of regulatory requirements the protocol is subject to. \n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"9. Review Level: Indicate the level of review at the time of initial review. Provide the exempt categories or the expedited review categories where appropriate. This item refers to the review/approval of the main study (not the addition of a local site by amendment).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"10. Risk Level: Indicate whether the protocol was determined to be minimal risk or greater than minimal risk.\t\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"11. FDA Regulated: Indicate whether the protocol is FDA regulated. Research is governed by FDA regulations when the research involves one or more human subjects and an FDA-regulated test article or human subjects research data will be submitted to or held for inspection by the FDA. [See 21 CFR 50.1(a), 21 CFR 312, and 21 CFR 812]\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: ADMINISTRATIVE INFORMATION (CONTINUED)"]
[null,"12. Sponsor / Funding: Enter the sponsoring organization(s) and all funding sources for the protocol being audited. Indicate \"N/A\" if there is no sponsor or funding.\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"13. Study Sites: Indicate where the protocol-related activities are taking place. Select all that apply.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"14. IRB of Record: Indicate the IRB of record for the protocol. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"15. Study Components: Indicate all components and whether documentation of additional required approval is on file, as applicable. The number of audited protocols involving international research, children, and prisoners must be reported annually on the FDC.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"• International Study: VHA Directive 1200.05(3)§25.b requires approval from the Facility Director for a VA investigator to conduct international research. CSP research requires approval from the CRADO. See: http://www.research.va.gov/resources/policies/guidance/intl-research.pdf. "]
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[null,"• Children: VHA Directive 1200.05(3)§21.a requires approval from the Facility Director for a VA investigator to conduct research involving children. See: http://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf."]
[]
[null,"• Prisoners: VHA Directive 1200.05(3)§20.a requires written permission from the CRADO for research protocols involving prisoners."]
[]
[null,"16. Data Repository: Indicate whether the protocol involves a data repository. If data collection resulted from research interventions in a different research protocol, then subject record review is not required. If data collection resulted from research interventions conducted as part of the research repository protocol, then subject record review is required. Informed consent documents must be reviewed if subjects provided informed consent as part of the research repository protocol and not via another protocol.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: KEY PROTOCOL DATES"]
[null,"17. Initial Approvals Reviewed Previous Audit: Indicate whether the key protocol dates and initial approvals were reviewed in a prior audit. If \"Yes,\" the remaining items in this section will gray out. This information does not need to be reentered, but can be at the RCO's discretion. \n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"18. Exemption Determination Review: Indicate the date the protocol was determined to be exempt.  ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"19. IRB Approval: Enter the initial IRB approval date. Indicate whether IRB approval was obtained prior to any research activities. For multi-site research, provide the date of initial approval for the specific site. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"20. PO Review: Enter the date of final PO review for the protocol. Then indicate whether final PO review was obtained prior to final R&DC approval. In most cases, the PO review is completed using the VA Form 10-250 (The Research Privacy Checklist). Note that the VA Central IRB is not required to use the VA Form 10-250. A preliminary PO review is required prior to IRB approval. However, a final PO review must be completed after IRB approval and before final R&DC approval. RCOs should review VHA Form 10-250, when required. Documentation of privacy review (VHA Form 10-250) must remain with the research protocol. [VHA Directive 1605.03(2)§5.n.(18); VHA Directive 1200.01(1)§5.k; VHA Directive 1200.01(1) §5.h(6)]\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"21. ISSO Review: Enter the date of ISSO review. Then indicate whether ISSO review was obtained prior to final R&DC approval. If an ISSO Review is not required (such as when the Enterprise Research Data Security Plan [ERDSP] form indicates that it is not required), enter “N/A” in this box. The RCO should ensure the ISSO has reviewed the ERDSP and must verify that ISSO review of the ERDSP was completed prior to final R&DC approval. [VHA Directive 1200.01(1) §5.i; VHA Directive 1200.01(1) §5.h(6)]",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"22. R&DC Approval: Enter the initial R&DC approval date. Then indicate whether R&DC approval was obtained prior to any research activities. \n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"23. ACOS/R Letter: Enter the ACOS/R letter date. Then indicate whether the ACOS/R letter was obtained prior to any research activities. \t\n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: EXEMPT PROTOCOLS"]
[null,"24. Exempt Elements Previously Audited: Indicate whether the exempt protocol was previously audited. If \"Yes,\" the remaining items in this section will gray out. This information does not need to be reentered, but can be at the RCO's discretion. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"25. Exempt Category(ies) Documented: Indicate whether the exemption determination category was appropriately documented. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[null,"The categories of exempt research under the 2018 Common Rule can be accessed here. "]
[]
[null,"26. Exempt Category Match: Indicate whether the given exemption determination category appears to match the regulatory description of the category. If the exempt category determination does not appear to match the regulatory description of the category, confer with the person(s) who made the exempt determination; if an incorrect determination is confirmed, report this as apparent serious noncompliance. If there is disagreement about the determination, please consult with ORO.\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"27. Require Limited IRB Review: Indicate whether the protocol required a limited IRB review based on the assigned exempt categories. Limited IRB review only applies to research subject to the 2018 Common Rule. Exempt categories requiring a limited IRB review include categories 2(iii), 3(c), 7, and 8. If the facility conducted limited IRB review on all exempt protocols, do not indicate a limited IRB review was conducted for exempt categories outside of 2(iii), 3(c), 7, and 8.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"28. Received Limited IRB Review: Indicate whether the protocol received a required limited IRB review. If the facility conducts limited IRB review on all exempt protocols, do not include the limited IRB review conducted on protocols for exempt categories outside of 2(iii), 3(c), 7, and 8. Use the comments section to include any additional information on local facility-specific limited IRB requirements. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"29. Direct Interaction: Indicate whether there is a direct interaction with human subjects as part of the research-specific activities.\t\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"30. Required Provisions: Indicate whether the protocol documents include required provisions. VHA Directive 1200.05(3)§10.c. requires that the following information be given to prospective subjects (in writing or orally) for exempt research activities involving investigator interaction with human subjects or obtaining information by educational tests, survey or interview procedures, or behavioral interventions: 1) The activity is research; 2) Participation is voluntary; 3) Permission to participate can be withdrawn; 4) Permission for use of data can be withdrawn for exempt research activities involving the collection and use of identifiable data; and 5) Contact information for the VA investigator.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: IRB CONTINUING REVIEW"]
[null,"31. CR Required by Policy: Indicate whether the protocol required IRB continuing review (CR) in accordance with VHA Directive 1200.05(3) for each year reviewed. Indicate \"N/A\" if the audit is being conducted before that review period (e.g., if the audit is conducted two years after initial approval, Year 1 would be \"N/A\"). For research subject to the pre-2018 Common Rule, continuing IRB review is required for all non-exempt human subjects research. For research subject to the 2018 Common Rule, continuing IRB review is not required for (a) Research eligible for expedited review; or (b) Research reviewed by the IRB in accordance with the limited IRB review; or (c) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: 1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, or 2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. [See VHA Directive 1200.05(3) §9.e.(2).] For research subject to the 2018 Requirements, if the IRB requires continuing review for any of the above circumstances, it must document its rationale for requiring continuing review in its communication to the investigator and institution. The R&D Committee is not required to conduct continuing review. [See VHA Directive 1200.05(3) §9.e.(2)]. Continuing review audits require a look-back to the beginning of the study or the date of the last audit. When a study has transitioned to the 2018 Common Rule during the look-back period and the study no longer requires continuing review, indicate “No” for “Is IRB Continuing Review (CR) required by VHA Directive 1200.05.” Note that annual check-ins required locally do not count as continuing review; failure to conduct a locally required check-in would be noncompliance with local SOPs, but not national Policy.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"32. CR Required by IRB: Indicate whether the IRB required continuing review for the protocol [that would not otherwise require continuing review in accordance with VHA Directive 1200.05(3)]. Indicate \"N/A\" if the audit is being conducted before that review period (e.g., if the audit is conducted two years after initial approval, Year 1 would be \"N/A\").\t\t\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"33. CR Rationale Documented: Indicate whether the rationale for the IRB-required continuing review was documented.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"34. CR as Scheduled: Indicate whether the required continuing review occurred as scheduled for each year during the look-back period. Year 1 is the first year after approval or the most recent protocol audit.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"35. Research During Lapse: Indicate whether any research activities occurred during a lapse in approval at any point during the look-back period.\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: SINGLE IRB REVIEW"]
[null,"36. Single IRB Review Requirement: Indicate whether the protocol is subject to the single IRB requirement. NOTE: As of January 20, 2020 (the compliance date for the single IRB requirement), single IRB review is required for all VA non-exempt Human Subjects Research with more than one institution engaged and the other Institution(s) is a federal institution (including another VA Facility) or the other non-Federal institution(s) is a recipient of Federal government funding or support for that research activity, unless the research was granted an exception from the requirement by ORD or other Common Rule agency. When the facility engages the services of another entity’s IRB as its IRB of Record, the IO is responsible for, among other things: Establishing and signing a Memorandum of Understanding (MOU) or Authorizing Agreement with other VA facilities or external organization(s) providing IRB services. Exceptions: When more than single IRB review is required by law (including tribal law); or whenever any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. [See 38 CFR 16.114.] To determine if the study is subject to the single IRB review requirements, RCOs may want to check with research coordinator or the VAIRRS cover sheet.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"37. Single IRB Review: Indicate whether the protocol received review by a single IRB.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"38. Valid Exception: Indicate whether a valid exception was granted by the Office of Research and Development (ORD) or another Federal entity supporting the research that allowed the protocol to NOT be reviewed by a single IRB. See the link for ORD-approved exceptions.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"ORD Single IRB Exception Requests - Single IRB Exception Exports - All Documents (sharepoint.com)"]
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[null,"39. External Single IRB: Indicate whether the reviewing single IRB was external to the VHA medical facility. IRBs that are external to the VHA medical facility include affiliated or unaffiliated IRBs, commercial IRBs, the VA CIRB, other federal agency IRBs (i.e., any IRBs other than the VA facility's internally operated IRB).",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"40. Valid Reliance Agreement: Indicate whether a valid reliance agreement was in place for the VHA medical facility to rely on an external IRB. Reliance agreements may be referred to by different terms, such as an MOU, an IRB Authorization Agreement, or IRB reliance agreement. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: INVESTIGATIONAL DRUGS"]
[null,"41. Investigational Drugs: Indicate whether the protocol involves the use of investigational drugs. For centralized dispensing protocols that are described in VHA Handbook 1108.04§15, in which the drug is sent from a centralized pharmacy and mailed to subjects, RCOs are not required to audit the pharmacy. However, centralized dispensing protocols are not typical and RCOs should ensure that the protocol being audited is confirmed to be a centralized dispensing protocol and not subject to the drug accountability requirements. Enter \"N/A\" for the questions related to the drug log and pharmacy procedures if a centralized dispensing protocol is confirmed. Otherwise complete the investigational drug questions below.\t\t\t",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"42. Drug Log or Accountability Record: Indicate whether the investigational drug log or accountability record contains all required elements. The investigational drug log or accountability record must contain the following, even if a sponsor drug log is used: [VHA Handbook 1108.04 §10.b(3)]\na. Name of the drug, dosage form, and strength\nb. Manufacturer or other supply source\nc. Date of receipt of the drug\nd. Quantity received\ne. Expiration, retest, or repass date\nf. Control, lot number, or other identification (ID) number\ng. Name of LSI \nh. Protocol name or number \ni. Name of subject or other subject identifier for individuals receiving the medication \nj. Quantity dispensed\nk. Balance of drug currently available (when amenable to protocol design)\nl. Recorder’s initials\nm. A final entry is made when drug therapy for the entire study (at the site) has ended ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"43. Investigational Drugs Stored Separately: Indicate whether investigational drugs are stored separately from regular pharmacy stock. RCOs should visually verify that investigational drugs are securely stored in the pharmacy, separate from all non-investigational drugs, and clearly identified as to which study they are assigned. Note: Storage does not require a separate locked area within pharmacy unless the medication has specific storage requirements. [VHA Handbook 1108.04 §10.b(1)]",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 appropriate research review committee (RRC) file (e.g., IRB for protocols subject to IRB review; R&DC as appropriate for exempt protocols followed by the R&DC only), including the protocol and all IRB/R&DC actions since initial approval or the last audit. This tab should be used to document the protocol history, including substantive actions of the IRB/R&DC related to the audited protocol in chronological order. This would include initial approval, amendments, continuing review/approval, and changes in staff. IRB actions related to the informed consent document and actions related to local unanticipated problems involving risks to subjects or others are recorded separately on the tabs of the tool that follow. As long as RCOs obtain all information required by this HRP audit tool, they may organize the information in the manner they choose to be most useful. RCOs should note any possible compliance issues related to IRB actions using the \"Comments.\" If the study no longer requires continuing review, note that in 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. RRC Dates: The date should be verified for each RRC action documented. This will allow RCOs to determine, as relevant, the timeliness of the action and the timeliness of any further actions that may be required by regulation, such as continuing review of approved protocols within 365 days, when required. Date of expiration of the action, if any, should also be recorded. If the RRC action was anything other than approval, make a note in the \"Comments\" section. The date of R&DC approval of IRB 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): In most cases 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 IRB, 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: INFORMED CONSENT"]
[null,"The \"Informed Consent\" tab of the HRP regulatory audit tool is to be used to record sequentially the versions of the informed consent document that have been approved by the IRB for this protocol, the date of approval, and whether re-consent was required. Although optional, it is a best practice for RCOs to check to ensure that the HIPAA authorization and informed consent document do not contain inconsistent information. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
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[]
[null,"3. Date of IRB Approval: The date of IRB approval of each version of the informed consent document (ICD) is necessary for the auditor to ensure that every subject received the current version of the ICD on the date of his/her signature. The date of the writing or revision of the document is used by some facilities as an identifier to refer to the ICD version; other facilities use a version number or other method. These document identifiers may be recorded in the first, optional columns of this page of the tool, or RCOs may redesign this tool adding additional information that makes it more effective for their facility and local standard operating procedures.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"5. Reconsent Required: If re-consent was required but did not occur, RCOs should note these findings in the \"Comments\" and report the finding appropriately. It is useful for RCOs to double-check that all subjects from whom re-consent was obtained were included in the ICD audit for that period.\n\n\n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
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[]
[null,"INSTRUCTIONS AND GUIDANCE: UPIRTSO REPORTING"]
[null,"The \"UPIRTSO Reporting\" tab of the HRP regulatory audit tool should be used to record all local apparent unanticipated problems involving risks to subjects or others (UPIRTSOs). RCOs should review each event to ascertain whether the required review and determinations occurred in the manner and time required by VA policy. VHA Directive 1058.01 requires local UPIRTSOs be reported to the IRB and reviewed by the IRB in an expedited manner. [VHA Directive 1058.01§7.b.] \n\n",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
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[]
[null,"1. Date Event Occurred: Record the date the event actually occurred (according to the documentation available) regardless of when it was first recognized and/or reported.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[]
[null,"2. Date Learned of Event: Record the date the event was first recognized to have occurred by any member of the research staff or the RCO. Under VHA policy, such recognition begins a timeline for reporting, evaluation, and possible action. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: UPIRTSO REPORTING (continued)"]
[null,"6. Reported on Time: Record whether the report was made in a manner compliant with time requirements. The time between the Date Learned of Event and Date Reported the Relevant Review Committee (RRC) should be checked for compliance with both local SOP and VHA Directive 1058.01 (within 5 business days), whichever is the shorter time. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[]
[null,"7. Reviewed on Time: Record (\"Yes\" / \"No\") whether the review occurred as required by policy. VHA Directive 1058.01 requires that, once the IRB has received a report of a local UPIRTSO, the IRB Chair or a qualified IRB member-reviewer must DETERMINE and DOCUMENT within 5 business days whether any actions are warranted to eliminate apparent IMMEDIATE HAZARDS to subjects, and, if so, initiated those actions. The IRB MUST REVIEW the incident and the determination of the IRB Chair or qualified IRB member-reviewer at its next CONVENED MEETING (not to exceed 30 calendar days after the date of written notification). The IRB must DETERMINE and DOCUMENT (no later than 30 calendar days after the convened meeting): (a) Whether the incident, experience, or outcome was unexpected and related to or possibly related to participation in the research and indicative of the research placing subjects or others at substantively greater risk of harm than was previously known or recognized (i.e., whether the incident, experience, or outcome constituted an actual UPIRTSO); and (b) What, if any, protocol or informed consent modifications are warranted. If modifications are warranted, the convened IRB must determine and document whether investigators must notify or solicit renewed or revised consent from previously enrolled subjects; and, if so, when such notification or consent must take place and how it must be documented. Local SOPs may require different review timelines. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"8. Unanticipated: Indicate whether the IRB determined that the event was unanticipated.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"9. Related / Possibly Related: Indicate whether the IRB determined the event was related or possibly related to the research. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"10. Increased Risk: Indicate whether the IRB determined that the incident was indicative of the research placing subjects or others at substantively greater risk of harm than was previously known or recognized. [VHA Directive 1058.01 §§3.q. & 7.b.]",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"11. Reported to ORO: Indicate \"Yes\" if reporting occurred in compliance with VHA and local policy. Indicate \"No\" if reporting did not occur in compliance with VHA and local policy. Indicate \"N/A\" if the determination did not require reporting. If the IRB determines that the event constituted an actual UPIRTSO (\"Yes\" in: \"unanticipated,\" \"related/possibly related,\" and \"increased risk\"), the IRB must notify the MFD, the RCO, and the ACOS/R in writing of its determinations within 5 business days. The MFD or designee must report the IRB's determination to ORO within 5 business days of receiving the IRB's written determination. [VHA Directive 1058.01§7.b.]",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 research-related training is current for all staff participating in the protocol on the date of the audit. Refer to the link below for current training requirements.",null,null,null,null,null,null,null,null,null,null,"RETURN"]
[]
[null,"https://www.research.va.gov/programs/ePROS/education/ord_training/options.cfm"]
[]
[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. 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 human subjects training is not current as of the time of the audit, the auditor should check if such 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: SUBJECT RECORD REVIEW"]
[null,"2. Documentation that Consent Obtained Prior to Initiation of Study Procedures: RCOs only need to audit a percentage of consents, as calculated on the worksheet. The date the subject signed the ICD should be compared with the documented date that study procedures began for the subject to ascertain that informed consent preceded beginning research. For research procedures that began on the same date that the subject signed consent, RCOs should follow the local policy regarding what documentation is necessary to determine that consent occurred before study procedures began. This comparison should be made for all audited studies requiring a signed informed consent document, including minimal risk studies and studies involving interventions of more than minimal risk. When documentation does not allow this determination, RCOs should ask for the study staff to describe the process they use to ensure that consent is always obtained prior to research procedures. RCOs should discuss any concerns with the PI and IRB Chair. [See 38 CFR§116.a(1), VHA Directive 1200.05(3)§5.g(9).]",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"INSTRUCTIONS AND GUIDANCE: SUBJECT RECORD REVIEW (continued)"]
[null,"3. Subject Not Meeting Inclusion or Meeting Exclusion Criteria was Included in Research (applies to greater than minimal risk research only): Auditing documentation of inclusion/exclusion criteria is only required if the study involves an intervention that is greater than minimal risk. When auditing inclusion/exclusion criteria for such studies, RCOs only need to audit a percentage of consents (as above). In determining whether a subject not meeting inclusion or meeting exclusion criteria was included in research, RCOs are not expected to review the inclusion or exclusion criteria against that patient’s medical record to determine if the subject is enrolled properly. RCOs should review all pertinent documentation available about each subject including (but not limited to) inclusion/exclusion criteria checklists, sponsor monitor/audit reports, protocol deviation submissions, CPRS study enrollment note, etc. If there is evidence that the subject did not meet the inclusion or did meet exclusion criteria and the subject was inappropriately enrolled in the study, this box should be marked “Yes.” This is noncompliance. If no documentation is available regarding inclusion/exclusion criteria for the subject, RCOs should seek guidance from the PI or study coordinator on how the criteria were assessed. ",null,null,null,null,null,null,null,null,null,null,"RETURN"]
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[null,"4. Progress Note Present in VHA Health Record (if required): RCOs audit for the presence of a progress note in VHA health record, if required. It is not required to audit the content of the health record note, only the presence. Answer “N/A” if no progress note in the VHA health record is required by VHA Directive 1200.05§5.g.(16): Creating or updating a VHA health record and creating a progress note for all research subjects (Veterans or non-Veterans) who receive research procedures or interventions as inpatients or outpatients at VA medical facilities that are either used in or may impact the medical care of the research subject at a VA medical facility or at facilities contracted by VA to provide services to Veterans (e.g., Community-Based Outpatient Clinics or community living centers). Informed consent and HIPAA authorization documents are not required to be in the health record.",null,null,null,null,null,null,null,null,null,null,"RETURN"]

{"sheet":"Additional Information","index":9,"n_rows":4,"n_cols":9,"rows_kept":4,"cut":false,"hidden":false,"merged":[[3,1,121,8],[2,1,2,7]]}
[]
[]
[null,"Item 28. Additional Information: Exemption Categories",null,null,null,null,null,null,"RETURN"]
[null,"The categories of exempt research under the 2018 Rule are:\n\nCategory 1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.  This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.\n\nCategory 2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by section 12.a.(7) of this directive.\n\nCategory 3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:\n(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by section 12.a.(7) of VHA Directive 1200.05(2) (4) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. (5) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.\n\nCategory 4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (1) The identifiable private information or identifiable biospecimens are publicly available; (2) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (3) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR Parts 160 and 164, Subparts A and E, for the purposes of health care operations or research as those terms are defined at 45 CFR 164.501 or for public health activities and purposes as described under 45 CFR 164.512(b); or\n(4) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities; if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501. NOTE: If all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a; and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.\n\nCategory 5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. (1) Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. (2) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the Federal department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.\nNOTE: The determination of exempt status for research and demonstration projects meeting the criteria for exempt category 5 in section e. in this Appendix must be made by the Under Secretary for Health on behalf of the Secretary of VA, after consultation with Office of Research and Development (ORD), Office of Research Oversight (ORO), Office of General Counsel (OGC), and other experts, as appropriate.\n\nCategory 6. Taste and food quality evaluation and consumer acceptance studies: (1) If wholesome foods without additives are consumed, or (2) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.\n\nCategory 7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by section 12.a.(8) of this directive.\n\nCategory 8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (1) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with section 17.f of VHA Directive 1200.05(2); (2) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with section 17 of VHA Directive 1200.05(2); (3) An IRB conducts a limited IRB review and makes the determination required by section 12.a.(7) of VHA Directive 1200.05(2) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph h.(1) of this section; and (4) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results."]

{"sheet":"Dropdowns","index":10,"n_rows":11,"n_cols":6,"rows_kept":11,"cut":false,"hidden":true,"merged":[]}
[]
["Yes","2018 Common Rule Requirements","PI","Active or actively enrolling new subjects","Minimal Risk","Local VA"]
["No","Pre-2018 Common Rule Requirements","SC","Active only for long-term observation","Greater than Minimal Risk","VA CIRB"]
["N/A",null,"SI","Active only for long-term data analysis",null,"Affiliate"]
[null,null,null,"New enrollments temporarily suspended/on hold",null,"NIH"]
[null,null,null,"Closed to new enrollments",null,"NCI"]
[null,null,null,"Closed/terminated",null,"Advarra"]
[null,null,null,null,null,"Sterling"]
[null,null,null,null,null,"WCG"]
[null,null,null,null,null,"Oakridge"]
[null,null,null,null,null,"Other"]