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["Date:"]
["Facility:",null,"Select Facility…"]
["Facility Contact:"]
["Facility Email:"]
[]
["Submission of this form should occur no later than August 1, 2022.  If updated information becomes available after August 1, 2022 please contact ORO at OROIDA@va.gov. "]
[]
[]
["PART A - CHECKLIST OF RESEARCH -RELATED REQUIREMENTS"]
[]
["Medical Facility Director - Institutional Responsibilities"]
["Questions shaded in yellow are new questions from previous FDC versions."]
["Questions with an orange border are related to common findings on ORO Combined Program Reviews."]
["1.","Select…","Are there adequate resources and administrative support, including personnel, space, equipment, and training for the Research and Development Committee (R&DC) and its subcommittees to fulfill their responsibilities? If “No,” please provide comments in the space below."]
[]
[]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.f(6); VHA Directive 1200.02(1) §11.e(2)-(3)"]
["2.","Has the Medical Facility Director:"]
[null,"Select…","a.  Appointed members of the R&DC and its subcommittees in writing? "]
[null,null,"VHA Directive 1200.01(1) §5.f(3)"]
[null,"Select…","b.  Delegated authority in writing for the roles and responsibilities within the facility’s Human Research Protection Program (HRPP)?"]
[]
[null,null,"VHA Directive 1200.05(2) §5.f(2)(c)"]
["3. ","Has the Research Compliance Officer (RCO):"]
[" ","Select…","a.  Maintained auditing plans and/or standard operation procedures (SOPs) for accomplishing required RCO informed consent audits and regulatory audits?\n\nVHA Directive 1058.01 §5.i(1)  "]
[]
[null,null,"VHA Directive 1058.01 §5.i(1) "]
[null,"Select…","b.  Completed all required annual informed consent and triennial regulatory audits for this reporting period? If “No,” please provide details in the space below. Include audit type(s) and number of audits to be completed. "]
[]
[]
[]
["4. ","Select…","Are any of the following positions currently unfilled or held by acting or interim personnel? If \"Yes\", please select all that apply.   If “No,” skip to Question 5."]
[]
[null,null,"Medical Center Director"]
[null,null,"Associate Chief of Staff/Research and Development (ACOS/R&D) or Coordinator for R&D"]
[null,null,"Administrative Officer/Research and Development"]
[null,null,"RCO "]
[null,null,"Research Committee Coordinator(s) Specify committee(s): "]
[]
[null,null,"For each position selected above, specify whether the positions are are vacant or whether acting or interim personnel have been assigned to the positions and the length of time assigned or vacant."]
[]
[null,"Select…","a.  If the ACOS/R&D has been acting/vacant for longer than 6 months, has Chief Research and Development Officer (CRADO) approval been obtained? "]
[]
[null,null,"VHA Directive 1200.02(1) §11.b(4)"]
["NOTES: Use the space box below to provide any additional information about items in the Medical Facility Director-Institutional Responsibilities section: "]
[]
[]
[]
["R&DC and ACOS/R&D Program Oversight Responsibilities"]
["5. ","Select…","Does your facility use the R&DC of another VA Facility?  If \"Yes,” please specify facility:"]
[]
[null,null,"If “Yes,” skip to Question 7."]
["6. ","Has the R&DC:"]
[null,"Select…","a.  Reviewed all research review committees and subcommittees at least annually and provided the Medical Facility Director with written summary reports of each review?"]
[]
[null,null,"VHA Directive 1200.01(1) §6.f; VHA Directive 1200.01(1) §8.a"]
[null,"Select…","b.  Reviewed subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes?"]
[]
[null,null,"VHA Directive 1200.01(1) §8.a(3)"]
[null,"Select…","c.  Ensured documentation of all applicable subcommittee review and non-contingent approval has been received by the R&DC before a study is given final approval?"]
[]
[null,null,"VHA Directive 1200.01(1) §9.b"]
[null,"Select…","d.  For research overseen by an external Institutional Review Board (IRB), determined and documented that the research supports the VA mission and is relevant to the care of Veterans, is scientifically meritorious, and is compliant with VA data and specimen storage requirements?"]
[]
[]
[]
[null,null,"VHA Directive 1200.01(1) §9.c"]
[null,"Select…","e.  Served as the review and approving committee of record for research not meeting criteria for assignment to any subcommittee?"]
[]
[null,null,"VHA Directive 1200.01(1) §9.d"]
[null,"Select…","f.  Ensured that only VA research activities are approved for collaborative studies?"]
[null,null,"VHA Directive 1200.01(1) §10.a"]
[null,"Select…","g.  Reviewed justification and provided specific approval for recruitment of non-Veterans?"]
[null,null,"VHA Directive 1200.01(1) §13.a"]
[null,"Select…","h.  Ensured Information System Security Officer (ISSO) review of studies involving the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.h(6); VHA Directive 1200.01(1) §5.i; VHA Directive 1200.01(1) §5.k"]
["7. ","Select…","Has the Research Program ensured investigators submit a VHA Research Protocol Privacy Review Checklist and an Enterprise Research Data Security Plan (ERDSP) to the PO and ISSO for protocols as required by VHA Directive 1200.01(1)?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.l(3)"]
["8.  ","Has the ACOS/R&D or Coordinator/R&D ensured:"]
[null,"Select…","a.  Written notification is provided to investigators when a research project can be initiated, and the period for which the project is approved, once the research project has been approved by all applicable subcommittees and the R&D Committee?"]
[]
[]
[null,null,"VHA Directive 1200.01(1) §5.g(2)"]
[null,"Select…","b.  All research personnel hold an official VA appointment from Human Resources Management Service (HRMS) as a compensated full-time or part-time employee, a Without Compensation (WOC), or under the Intergovernmental Personnel Act (IPA) prior to conducting or being involved in any way in VA research activities?"]
[]
[]
[]
[null,null,"VHA Directive 1200.02(1) §12.a(4)(a)"]
[null,"Select…","c.  All requests for WOC appointments for research have been appropriately justified and the appointments are in compliance with all applicable research, HRMS, and other VA policies?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §12.a(4)(b)"]
["9. ","Does the Research Office have an established system to track:"]
[null,"Select…","a.  Research studies, including study status, type of study, sponsor, funding source, PI, and required committee approvals?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(a)"]
[null,null,"Specify all tracking system(s) currently used for research committee management (e.g., VAIRRS, iMedris, affiliate research management systems, etc.): "]
[]
[]
[null,"Select…","b.  Research review committee actions, including all initial and continuing review approvals?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(b)"]
[null,"Select…","c.  Agreements, including all local Cooperative Research and Development Agreements (CRADA), research contracts, research Memoranda of Understanding (MOUs), and other written research agreements?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(c)"]
[null,"Select…","d.  Personnel, including all investigators, research coordinators, research assistants, research technicians, and others conducting any aspect of research at the VA medical facility?"]
[]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(d)"]
[null,"Select…","e.  Completion of all ORD-required training and Annual Government Ethics training (for Investigators) for all research personnel?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(e)"]
[null,null,"f.  An inventory of all research data:"]
[null,"Select…","(1)  that are placed in a research data repository for future use?"]
[null,"Select…","(2)  that are being stored until the retention requirement has been met per Record Control Schedule 10-1?"]
[]
[null,null,"VHA Directive 1200.02(1) §5.b(1)(f)"]
["NOTES: Use the text box below to provide any additional information about items in the R&DC and ACOS/R&D Program Oversight Responsibilities section:"]
[]
[]
[]
["HRPP and IRB Responsibilities"]
["10. ","Institutional Review Board:"]
[null,"Select…","a.  Does your facility operate its own internal IRB to perform review and oversight of human subjects research?"]
[]
[null,"Select…","b.  Does your facility use an IRB operated by your facility's academic affiliate institution(s)? If \"Yes,\" specify affiliate:"]
[]
[]
[null,"Select…","c.  Does your facility use an IRB operated by another VA Facility?  \nIf \"Yes,\" specify VA Facility: "]
[]
[]
["11.","Has the IRB ensured:"]
[" ","Select…","a.  For protocols reviewed by the convened IRB, the IRB minutes document that the IRB determined that all of the criteria for approval of the research were satisfied?"]
[]
[null,null,"VHA Directive 1200.05 §8.c(1); VHA Directive 1200.05 §12.a(1)-(8)"]
[null,"Select…","b.  Informed consent documents contain all required elements?"]
[null,null,"VHA Directive 1200.05 §17"]
[null,"Select…","c.  Requests to waive informed consent are appropriately reviewed and determinations to grant waivers are fully and appropriately documented? "]
[]
[null,null,"VHA Directive 1200.05 §17.h "]
[null,"Select…","d.  Requests to waive HIPAA authorization are appropriately reviewed and determinations to grant waivers are fully and appropriately documented and include the signature of the Chair of the IRB, or a qualified voting member of the IRB designated by the Chair?"]
[]
[]
[null,null,"VHA Directive 1200.05 §23.b "]
["12.","For research subject to the 2018 Common Rule requirements, has the IRB ensured:"]
[null,"Select…","a.  Updated procedures are in place for exempt research including limited IRB review of certain exempt research categories?"]
[]
[null,null,"VHA Directive 1200.05(2) §10; VHA Directive 1200.05(2) §10.d-h  "]
[null,"Select…","b.  Documenting the rationale for conducting continuing review of research that otherwise would not require continuing review (i.e., research eligible for expedited review, research receiving a limited IRB review, and research that has progressed to only data analysis and/or only accessing follow-up clinical data as part of clinical care)?"]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §9.e(2)-(3) "]
[null,"Select…","c.  Documenting the rationale for an expedited reviewer's determination that research appearing on the expedited review list is more than minimal risk, and therefore not eligible for expedited review?"]
[]
[]
[null,null,"VHA Directive 1200.05(2) §16.a(8) "]
[null,"Select…","d.  ICDs and documented waivers of informed consent contain new requirements?"]
[null,null,"VHA Directive 1200.05(2) §17.b; VHA Directive 1200.05(2) §17.d(9)(a)&(b) as applicable; VHA Directive 1200.05(2) §17.e(7)-(9) as applicable; VHA Directive 1200.05(2) §17.g-h [waivers]; VHA Directive 1200.05(2) §18.b(2) as applicable     "]
[]
[]
[null,"Select…","e.  For clinical trials, procedures are in place to ensure that one approved informed consent form is posted no later than 60 days after the last study visit by any subject to https://clinicaltrials.gov or http://Regulations.gov (Docket ID: HHS-OPHS-2018-0021)? If clinical trials are not conducted, choose N/A."]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §17.j "]
["13.","Select…","Is broad consent allowed by local policy? If “No,” skip to Question 14."]
[null,"Select…","a.  If “Yes” to #13, has the IRB ensured broad consent is only approved for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens that are collected solely for research purposes?"]
[]
[]
[null,null,"VHA Directive 1200.05(2) §17.f "]
[null,"Select…","b. If \"Yes\" to #13, has broad consent been approved in conjunction with any active human subject protocols at your facility?"]
[]
["14.","Select…","Does your facility use any of the following IRBs?  If \"Yes,\" select all IRBs your facility currently relies on (or are approved to rely on if research has not yet been reviewed by the IRB):"]
[]
[]
[null,null,"VA Central IRB"]
[null,null,"National Cancer Institute (NCI) IRB"]
[null,null,"National Institutes of Health (NIH) All of Us IRB"]
[null,null,"Advarra, Inc. IRB"]
[null,null,"Oak Ridge Associated Universities IRB"]
[null,null,"Sterling IRB"]
[null,null,"WIRB-Copernicus Group (WCG) IRB"]
["15. ","Select…","Does your facility use any other IRB not already identified in questions #10 and #14 above? If \"Yes,\" specify IRB(s): "]
[]
[]
[null,"Select…","a.  If “Yes” to #15, has your facility received approval from ORD to use the IRB(s)? \n"]
[null,null,"VHA Directive 1200.05(2) §5.f(9)"]
["16. ","Select…","For IRBs other than the internal IRB operated by your facility, is there a current (i.e., not expired) reliance agreement or MOU in place documenting the facility’s reliance on that IRB and the responsibilities that each entity will undertake to ensure compliance with the Common Rule and applicable VHA policies (e.g., VHA Directive 1200.05(2), VHA Directive 1058.01, etc.)?"]
[]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §16.a(9); VHA Directive 1058.03 §5.f(10)(a)-(d) and (12)"]
["17. ","Select…","For cooperative research subject to the single IRB requirement, is the research reviewed by a single IRB unless an exception has been granted by ORD?\nIf cooperative research is not conducted, choose N/A."]
[]
[]
[null,null,"NOTE: Effective July 19, 2018, 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."]
[]
[]
[]
[]
[null,null,"38 CFR 16.114; See also Single IRB Implementation in VAs at "]
[null,null,"www.research.va.gov/programs/orppe/single_irb.cfm"]
["18. ","Select…","Is your facility's Federalwide Assurance (FWA) through the Office for Human Research Protection (OHRP) current and in good standing for your facility’s HRPP?\nPlease provide expiration date of FWA:"]
[]
[]
[]
[null,null,"32 CFR §16.103; VHA Directive 1058.03 §5.f(1); VHA Directive 1058.03 §6.a   "]
["19. ","Are the following SOPs related to the HRPP up-to-date so as to accurately reflect current Federal requirements and VHA policies:"]
[]
[null,"Select…","a.  SOP(s) for review of research and reporting actions and determinations?"]
[null,null,"VHA Directive 1200.05 §8a; VHA Directive 1200.01(1) §6.e  "]
[null,"Select…","b.  A documented procedure for determining when research approved by the IRB prior to January 21, 2019, can transition to the 2018 Common Rule Requirements, if applicable?"]
[]
[null,null,"VHA Directive 1200.05(2) §5.f(5)"]
[null,"Select…","c.  SOP(s) for review and reporting of unanticipated problems involving risks to subjects or others and serious or continuing noncompliance (if developed) have been updated to align with reporting timelines and requirements in VHA Directive 1058.01, dated October 22, 2020? "]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §8.a(4); VHA Directive 1058.01 §7.(b)-(c)  "]
["20. ","Select…","Does the Privacy Officer review written HIPAA authorizations and waiver of HIPAA authorization approvals to ensure they contain all required elements and are consistent with all privacy requirements before investigators begin to use or collect individuals’ information? "]
[]
[]
[]
[null,null,"VHA Directive 1200.05(2) §23.a(3); VHA Directive 1605.03(1) Appendix D §1.k(7) "]
["21. ","Select…","Does your facility conduct research involving investigational drugs as defined by VHA Handbook 1108.04? If \"No,\" skip to Question 22."]
[]
[null,"Select…","a.  Does the research include investigational drugs under an Investigational New Drug Application (IND)?"]
[]
[null,"Select…","b.  Does the research include human gene therapy products (including treatments or vaccine trials involving viral vectors or synthetic RNA/DNA)?"]
[]
[null,"Select…","c.  If “Yes” to #21b, is there a process in place for such research to be reviewed by a properly constituted Institutional Biosafety Committee (IBC) (in addition to an IRB) as required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - April 2019, Section III-C-1?"]
[]
[]
[]
[null,null,"https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf"]
[null,"Select…","d.  Are any investigational drugs stored outside of the research pharmacy?"]
[null,null,"If “Yes,” please provide details of all investigational drugs maintained outside of the research pharmacy including the protocol and rationale for storage outside the pharmacy: "]
[]
[]
[null,"Select…","e.  If “Yes” to #21d, is a delegation of custody in place?"]
[null,null,"VHA Handbook 1108.04 §10.c "]
[null,"Select…","f.  Does your facility conduct human subjects research involving the use of controlled substances? If \"No,\" skip to Question 22."]
[]
[null,"Select…","g.  If “Yes” to #21f, are the controlled substances stored in accordance with VHA Directive 1108.01(1)?"]
[]
[null,null,"VHA Directive 1108.01(1) §4.g(9) "]
[null,"Select…","h.  If “Yes” to #21f, do the controlled substances receive monthly unannounced controlled substance inspections as required by VHA Handbook 1108.04 and VHA Directive 1108.02?"]
[]
[null,null,"VHA Handbook 1108.04 §10.b(5)(b); VHA Directive 1108.02(2) §7   "]
["22. ","Select…","Does your facility conduct research involving investigational devices? If \"No,\" skip to Question 23."]
[]
[null,"Select…","a.  If \"Yes\" to #22, Does the research include significant risk device studies?"]
[null,"Select…","b.  If “Yes” to #22a, have the studies received Investigational Device Exemption (IDE) approval from the FDA?"]
[]
[null,null,"21 CFR 812.3(m)"]
["23.","Select…","Has your facility approved any research involving women who are known to be pregnant, human fetuses, or neonates as subjects?"]
[]
[null,"Select…","a.  If “Yes” to #23, were the appropriate certifications and/or approvals in place? "]
[null,null,"VHA Directive 1200.05(2) §19"]
["NOTES: Use the text box below to provide any additional information about items in the HRPP and IRB Responsibilities section:"]
[]
[]
[]
["Animal Care and Use Program (ACUP) and\nInstitutional Animal Care and Use Committee (IACUC) Responsibilities"]
["24.","Select…","Does your facility have an Animal Care and Use Program (i.e., does any research, testing or training conducted by your facility staff, either in VA space or with VA funds or on VA time regardless of location, involving the use of laboratory animals)?\nIf \"No,\" skip to Question 37."]
[]
[]
[]
["25.","Select…","Does your facility have its own internal IACUC of record to perform review and oversight of animal research? If \"No,\" skip to Question 26."]
[]
[null,null,"If \"Yes\" to #25, are IACUC members appointed in writing by the Medical Facility Director in accordance with VHA requirements prior to starting a term, including:"]
[]
[null,"Select…","a.  IACUC Chair?"]
[null,null,"VHA Handbook 1200.07 §8.a(2) "]
[null,"Select…","b.  Required Members, including scientist(s), non-scientist(s), non-affiliated member(s), and a veterinarian?"]
[]
[null,null,"VHA Handbook 1200.07 §8.a(1) "]
["26.","Select…","Does your facility use an affiliate IACUC(s), in lieu of a VA IACUC, as the IACUC-of- record (i.e., No VA IACUC)?\nIf “Yes,” specify affiliate(s):"]
[]
[]
[]
[null,"Select…","a.  Are the Veterinary Medical Officer (VMO) or Veterinary Medical Consultant (VMC) and at least one other VA compensated scientist with animal research experience appointed to the affiliate’s IACUC as voting members with full committee privileges?"]
[]
[]
[null,null,"VHA Handbook 1200.07 §8.b(1)(f) "]
[null,"Select…","b.  Is the MOU for use of the affiliate IACUC(s) current?"]
[null,null,"VHA Handbook 1200.07 §8.b(1) "]
["27.","Select…","Does your facility use an affiliate IACUC(s) in addition to the VA IACUC-of-record for shared oversight of off-site VA animal research?  If “Yes,” specify affiliate(s):"]
[]
[]
[null,"Select…","a.  If “Yes” to #27, are shared oversight mechanisms between the VA and affiliate IACUC(s) established in an MOU?"]
[]
["28.  ","What is the status of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation for your institution (or the institution whose accreditation that covers your program) as of the date this form is submitted? "]
[]
[]
[null,"VHA Handbook 1200.07 §7.e "]
[null,null,"Select…"]
[null,null,"a.  Please provide the date of the last AAALAC accreditation determination letter: "]
[]
["29.","Select…","Is your institution registered with the United States Department of Agriculture (USDA)?"]
["30.","Select…","Does your facility have any approved protocols involving non-USDA-regulated species (e.g.,  purpose-bred rats and mice, birds, amphibians) used for VA research? If “Yes,” please specify species AND locations housed: "]
[]
[]
[]
["31.","Select…","Does your facility have any approved protocols that involve the following USDA-regulated species used for VA research?  If \"No,\" skip to Question 32."]
[]
[null,"Select…","a.  Canines; If \"No,\" skip to Question 31b; If “Yes,” please specify locations housed:"]
[]
[null,"Select…","(1)  Is the canine research funded by the VA?"]
[null,"Select…","(2)  Has the canine research been approved by the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","b.  Felines; If \"No,\" skip to Question 31c; If “Yes,” please specify locations housed: "]
[]
[null,"Select…","(1)  Is the feline research funded by the VA?"]
[null,"Select…","(2)  Has the feline research been approved by ORD and the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","c.  Non-human primates (NHP); If \"No,\" skip to Question 31d; If “Yes,” please specify locations housed:"]
[]
[]
[null,"Select…","(1)  Is the NHP research funded by the VA?"]
[null,"Select…","(2)  Has the NHP research been approved by ORD and the VA Secretary?"]
[null,null,"Consolidated Appropriations Act, 2022 (Public Law 117-103), dated 3/15/2022, Section 247(a)-(e) "]
[null,"Select…","d.  Swine; If \"No,\" skip to Question 31e; If “Yes,” please specify locations housed:"]
[]
[null,"Select…","e.  Rabbit; If \"No,\" skip to Question 31f; If “Yes,” please specify locations housed:"]
[]
[null,"Select…","f.  Other USDA-regulated Species; If “Yes,” please specify species AND locations housed:"]
[]
["32.","Animals used for VA research are housed:"]
[null,null,"Select…"]
["NOTE:  Questions #33-#35 apply only to VA animal facilities.  Question #36 applies only to affiliate animal facilities."]
[]
["33.","For VA animal facilities, has your facility ensured:"]
[null,"Select…","a.  Heating, Ventilation, and Air Conditioning (HVAC) motors, belts, and equipment are on a regular preventive maintenance program to prevent HVAC failures?"]
[]
[null,null,"VHA Handbook 1200.07 APP.E.§3.b(7)"]
[null,"Select…","b.  Reheat systems (e.g., reheat coils, valves, etc.) in animal rooms are set to fail in the off or safe position to prevent catastrophic overheating of animals?"]
[]
[null,null,"VHA Handbook 1200.07 §7.a(2)(a)&(b); APP.E.§3.b(9)"]
[null,"Select…","c.  Overheat tests of the animal facility are conducted at least once every fiscal year, the results are provided to the IACUC for review at the next convened IACUC meeting, and reviews are documented in the IACUC meeting minutes?"]
[]
[]
[null,null,"VHA Handbook 1200.07 §7.a(2)c"]
[null,"Select…","d.  Security measures are implemented to exclude the entry of unauthorized personnel? "]
[null,null,"VHA Handbook 1200.07 §7.i and VA Handbook 0730 Appendix B "]
[null,"Select…","e.  The animal facility is equipped with emergency power?"]
[null,null,"VHA Handbook 1200.07 APP.E.§3.b(8)"]
["34.","How has the IACUC fulfilled requirements for ongoing assessment of the VA ACUP?\nSelect one option below:"]
[null,null,"Select…"]
[null,"Select…","a.  Were semi-annual program evaluations conducted at six-month intervals?"]
[null,null," VHA Handbook 1200.07 §8.f(1) "]
[null,"Select…","b.  Were semi-annual facility inspections conducted at six-month intervals?"]
[null,null," VHA Handbook 1200.07 §8.f(1) "]
[null,"Select…","If “No,” was a waiver obtained from OLAW in writing? "]
[null,"Select…","c.  Was the Medical Facility Director briefed on the results of the semi-annual program evaluation and facility inspections during a meeting with the IACUC Chair, the veterinarian, and the Associate Chief of Staff for Research in compliance with ORD/ORO joint guidance found here:"]
[]
[]
[]
[null,null,"https://www.va.gov/ORO/Docs/Guidance/Joint_Guidance_on_Semi_annual_Reviews_of_the_ACUP.docx? "]
[null,"Select…","d.  Did semi-annual program review reports contain a plan and schedule for correction of deficiencies?"]
[]
[null,null,"VHA Handbook 1200.07 §8.f(1)(d)(2) "]
[null,"Select…","e.  Were all significant deficiencies identified corrected within the timeframe(s) specified by the IACUC?\n"]
[]
[null,null,"(Choose N/A if no significant deficiencies were identified.) "]
[null,null,"If “No,” please provide additional details: "]
[]
["35.","For VA animal facilities, veterinary medical services are provided by:  Select one option below:"]
[null,null,"Select…"]
[null,"Select…","a.  If part-time (including contracted) veterinary services are provided, did arrangements include regularly scheduled visits, not less than once per month, written documentation of veterinary visits and a written plan that has been developed and approved by the veterinarian and the ACOS/R&D?  If “No,” provide additional information:"]
[]
[]
[]
[]
[null,null,"VHA Handbook 1200.07§6.b(8)"]
["36. ","For affiliate animal facilities:"]
[null,"How has the IACUC fulfilled requirements for semi-annual assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research?"]
[]
[null,null,"Select…"]
[null,null,"VHA Handbook 1200.07§8.f(1)(a) "]
["NOTES:  Use the text box below to provide any additional information about items in the ACUP and IACUC Responsibilities section:"]
[]
[]
[]
["Research Safety and Security Program (RSSP) and Subcommittee on Research Safety (SRS) Responsibilities"]
["37.","Select…","Does any research conducted by your facility staff involve biological, chemical, physical (including animal contact), or radiation hazards?"]
[]
[null,"Select…","a.  Has your facility obtained a waiver for the requirement for an SRS by the CRADO? If \"Yes,\" skip to Question 46."]
[]
[null,null,"VHA Directive 1200.08(1) §5.c(2)"]
["38.","Select…","Does your facility have an internal SRS administered within the VA facility that carries out duties described in VHA Directive 1200.08(1)? If \"No,\" skip to Question 39."]
[]
[null,null,"If \"Yes\" to #38, are SRS members appointed in writing by the Medical Facility Director for terms up to 3 years (renewable), including:"]
[]
[null,"Select…","a.  SRS Chair?"]
[null,null,"VHA Directive 1200.08(1) §5.f(7) "]
[null,"Select…","b.  At least 5 voting members exclusive of ex-officio members, including members with expertise regarding occupational safety and health, environmental protection, Department of Transportation (DOT) International Air Transport Association (IATA) requirements, knowledge of the space and facilities assigned to each PI?"]
[]
[]
[]
[null,null,"VHA Directive 1200.08(1) §6.b(1) "]
[null,"Select…","c.  A member from the facility Safety Committee (facility Safety Officer or a member of the facility Infection Control Committee) and an individual with radiation safety expertise?"]
[]
[null,null,"VHA Directive 1200.08(1) §6.b(1)(e) "]
[null,"Select…","d.  A liaison between the SRS and IACUC (if applicable; can be voting or non-voting)?"]
[null,null,"VHA Directive 1200.08(1) §6.b(1)(f) "]
[null,"Select…","e.  Required ex-officio members (R&DC liaison (non-voting), employee union safety representative or other union designee (voting status determined by local contract)?"]
[]
[null,null,"VHA Directive 1200.08(1) §6.b(2) "]
["39.","Select…","Does your facility use an external SRS/safety committee (not IBC) administered by another VA or an affiliated university?\nIf “Yes,” specify VA facility or affiliated university:"]
[]
[]
[]
[null,"Select…","a.  If \"Yes,\" are the MOUs for the use of an external SRS/safety committee current?"]
[null,null,"VHA Directive 1200.08(1) §6.a(2) "]
["40. ","Select…","Does your program conduct recombinant DNA (rDNA) research requiring review by an Institutional Biosafety Committee (IBC) as defined by NIH-Office of Science Policy (NIH-OSP)?   If \"No,\" skip to Question 41."]
[]
[]
[null,null,"VHA Directive 1200.08(1) §6.d(4) "]
[null,"Select…","a.  Does your facility have an internal IBC to review rDNA research in accordance with NIH guidelines?"]
[]
[null,null,"VHA Directive 1200.08(1) §7.a "]
[null,null,"b.  If “Yes” to #40a, please indicate below how your IBC is set up."]
[null,null,"Select…"]
[null,"Select…","c.  Is the VA IBC registered with NIH-OSP? "]
[null,null,"VHA Directive 1200.08(1) §7.b "]
[null,null,"Enter date of most recent registration/update for the VA IBC:"]
[]
[null,"Select…","d.  Does your facility use the services of an external IBC from another VA facility or an affiliated university to review rDNA research in accordance with NIH guidelines?"]
[]
[null,null,"If “Yes,” specify VA facility or affiliated university: "]
[]
[null,"Select…","e.  If \"Yes\" to #40d, is the institution's IBC registered with NIH-OSP as the IBC-of-Record for the VA facility?"]
[]
[null,null,"VHA Directive 1200.08(1) §7.e(5); VHA Directive 1200.08(1) §7.f(2)  "]
[null,null,"Enter date of most recent registration for the external IBC: "]
[]
[null,"Select…","f.  If using an affiliated university IBC, is the MOU for use of the external IBC current?"]
[null,null,"VHA Directive 1200.08(1) §5.m(2) "]
["41. ","Select…","Does your facility conduct any laboratory/bench research (excluding BSL-3)?  If \"No,\" skip to Question 42."]
[]
[null,"On-site VA laboratories:"]
[null,"Select…","Approximate number of active laboratories at on-site VA locations"]
[null,null,"Specify the locations of all on-site VA research laboratories"]
[]
[null,"Off-site VA-leased:"]
[null,"Select…","Approximate number of active laboratories at off-site VA-leased locations"]
[null,null,"Specify the locations of all off-site VA research laboratories"]
[]
[null,"Off-site Non-VA (i.e., non-leased):"]
[null,"Select…","Approximate number of active laboratories at off-site non-VA (non-leased) locations"]
[null,null,"Specify the locations of all off-site Non-VA (i.e., non-leased) research laboratories"]
[]
[null,"Select…","a.  For off-site non-VA (i.e., non-leased) laboratories, are the appropriate off-site waivers in place?"]
[]
[null,null,"VHA Program Guide 1200.16 §4.a-d (August 2, 2018) "]
[null,"Select…","b.  For VA research conducted in laboratories located in approved off-site facilities, has the ACOS/R&D (or equivalent) ensured there is a process in place for VA research to be reviewed with regard to research safety and security, and if necessary, provide feedback to the responsible party for the off-site facility on any deficiencies in such processes?"]
[]
[]
[]
[null,null,"VHA Directive 1200.08(1) §5.g(2)"]
["42. ","Select…","Does your facility conduct any research that requires a BSL-3 laboratory? If \"No,\" skip to Question 43."]
[]
[null,null,"If “Yes,” specify infectious agent(s):"]
[]
[null,"Select…","a.  Does your facility have its own BSL-3 laboratory located in the facility or in VA-leased space?"]
[]
[null,null,"If “Yes,” specify location(s):"]
[]
[null,"Select…","b.  Does your facility conduct VA-funded research at any off-site non-VA (i.e., non-leased) BSL-3 laboratories?"]
[]
[null,null,"If “Yes,” specify location(s):"]
[]
[null,"Select…","c.  Does your facility have a laboratory-specific safety manual for research requiring BSL-3 containment?"]
[]
[null,null,"BMBL 6th Edition §V.A.7 (Animal Biosafety Level 3, p.88); BMBL 6th Edition §IV.A.4. (Biosafety Level 3, p.44)  "]
[null,"Select…","d.  Does your facility maintain long-term storage (>6 months) of any SARS-CoV-2 positive samples or viral isolates?"]
[]
["43.","Select…","Does your facility conduct any research that involves chemical hazards, as defined by the Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT) and Environmental Protection Agency (EPA)?  If \"No,\" skip to Question 44."]
[]
[]
[null,"Select…","a.  Does your facility have a research-specific Chemical Hygiene Plan (which may be included in the Research Safety Plan) that is reviewed annually?"]
[]
[null,null,"29 CFR §1910.1450 (e)(3) "]
[null,"Select…","b.  Does your facility conduct semi-annual comprehensive inventory reviews  of hazardous chemicals/agents used in research?"]
[]
[null,null,"VHA Directive 1200.08(1) §5.h(1); VHA Directive 1200.08(1) §5.k; VHA Directive 1200.08(1) §5.n(5)   "]
["44.","Select…","Does your facility conduct any research that involves the use of regulated and/or exempt quantities of Select Agents and Toxins (SATs), as defined by the Federal Select Agent Program (FSAP)?  If “Yes,” specify toxin(s) and category (exempt/nonexempt): "]
[]
[]
[]
["45.","Are the following items related to VA research laboratories and the RSSP current, in place, and/or conducted as specified:"]
[]
[null,"Select…","a.  Research Safety Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","b.  Research Security Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","c.  Emergency Management Plan?"]
[null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,"Select…","d.  Bloodborne pathogen exposure control plan? (Select “Yes” if Research Service follows the hospital-wide plan.)"]
[]
[null,"Select…","e.  Bloodborne pathogen training (which should include an explanation of the OSHA standard and how to access the standard, an explanation of the Exposure Control Plan and how to access the plan, and an opportunity for questions and answers in real time during the training)?"]
[]
[]
[]
[null,null,"29 CFR §1910.1030(g)(2)(vii) "]
[null,"Select…","f.  A process to activate, decommission, or transfer PI laboratories?"]
[null,null,"VHA Directive 1200.08(1) §5.g(8); VHA Directive 1200.08(1) §5.n(1)  "]
[null,"Select…","g.  SRS annual review of each PI’s VA laboratory program?"]
[null,null,"VHA Directive 1200.08(1) §6.f "]
[null,"Select…","h.  Annual safety inspections of all research laboratories?"]
[null,null,"VHA Directive 1200.08(1) §5.n(6) "]
[null,"Select…","i.  Annual drills to test the effectiveness of each research-specific plan:  safety/biosafety, security, chemical hygiene, and emergency management?"]
[]
[null,null,"VHA Directive 1200.08(1) §5.n(9); 21 CFR 1910.1450 (e)(4)  "]
[null,"Select…","j.  Eye wash stations/emergency showers located, installed, maintained, and tested in research areas in accordance with VHA Directive 7704?"]
[]
[null,null,"21 CFR §1910.151 (c); VHA Directive 7704 (including Appendices A-F)  "]
[null,"Select…","k.  Opportunity for enrollment in the animal-user specific component of the Occupational Safety and Health Program (OSHP) for personnel with potential contact with animals and annual medical follow-up of enrolled individuals is conducted?"]
[]
[]
[null,null,"VHA Handbook 1200.07 APP.C.§4.a "]
[null,"Select…","l.  Personal protective equipment (PPE) hazard assessments certified for hazards in VA research laboratories/animal facilities?"]
[]
[null,null,"29 CFR 1910.132 (d); VHA Directive 1200.08(1) §5.p(8)   "]
[null,"Select…","m.  Controlled access to all laboratories at all times? "]
[null,null,"VHA Handbook 1200.07 §7.i and VA Handbook 0730 Appendix B "]
["NOTES: Use the text box below to provide any additional information about items in the RSSP and SRS  Responsibilities section:"]
[]
[]
[]
["Research Information Security Practices (RISP)\nPlease consult with your ISSO and/or VA Office of Information and Technology (OIT) Area Manager when answering the following questions."]
["46. ","Select…","Do researchers use any system interconnections between the VA facility network and a non-VA network for VA research purposes?"]
[]
[null,null,"This question pertains to direct connections between the VAMC network and a non-VA network. These system interconnections involve configuration and approvals by OIT and sometimes exist for biomedical equipment. Current VA OIT policy requires that an approved Memorandum of Understanding/Interconnection Security Agreement for each interconnection. If any interconnections are used for research purposes, the MOU must include that business purpose of the interconnection. Reference: VA Office of Information Security (OIS) Knowledge Service (KS), Control Number CA-3, Control Correlation Identifier (CCI) CCI-000257."]
["47.","Select…","Do researchers use any non-VA networks (e.g., air-gapped networks) and associated devices (e.g., affiliate computers) at the facility for VA research purposes? If \"No,\" skip to Question 48."]
[]
[null,null,"This question pertains to non-VA networks physically located at the VAMC but are not directly connected to the VA network. These are typically affiliate networks or networks associated with external internet service providers. "]
[null,"Select…","a.  If \"Yes\" to #47, do researchers use the non-VA network(s) to process, store, or transmit VA information? "]
[]
[null,null,"If a non-VA information system, such as an affiliate network, is used to transmit, process, or store VA data (data obtained or generated under an R&DC approved protocol, whether bench, animal, or human research), current VA OIT policy requires the establishment and documentation of terms and conditions, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing for such uses of VA data on the external information system(s).  "]
[null,"Select…","b. If \"Yes\" to #47b, are there instances where the VA information is considered VA sensitive information (VASI)?  "]
[]
[null,null,"If the information includes VA sensitive information (VASI), current VA OIT policy requires documenting the security controls/requirements of the non-VA information systems used to transmit, process, and/or store VASI in a contract or agreement (e.g., data use agreement) as specified in the procedures or templates provided for those types of agreements. This question does not apply to instances where a VA researcher properly discloses data to a non-VA entity and does not retain ownership (e.g., for future use in VA research), such as when VA provides data to a study coordinating site in a case report form and retains a copy for VA records. Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336; Control Number AC-19, CCI-002329, CCI-002330 "]
["48.","Select…","Do researchers transport VASI off-site/outside the VA?"]
[null,null,"This question pertains to the transport of VA sensitive information (e.g., identifiable subject data, completed informed consent forms) in any format outside of VA managed facilities. Current VA policy requires that all employees must have documented approval from their supervisor before sensitive information can be removed from a VA facility. References:  VHA Dir 1605.01 §2.g(6); VA Handbook 7002, Part 13 §5; VA OIS KS, Control Number  §MP-5, CCI-001024 "]
["49.","Select…","Are non-VA external information systems (IT equipment) used on-site for VA research?"]
[null,null,"If so, current Logistics Management policy requires that equipment owned by an affiliated institution, or purchased by such institution from grant funds, and used by a VA investigator in a research project at the VA facility must be accounted for on an equipment inventory list (EIL) contained in the facility property management system. Reference: VA Handbook 7002 §11.3.a, Appendix I §10.c "]
["50.","Select…","Are VA mobile devices (e.g., laptops, tablets) and VA portable devices (e.g., thumb drives, removable media) used for VA research?"]
[]
[null,null,"This question pertains to VA devices that are used for sensitive and non-sensitive VA data. If so, current VA OIT policy requires that if the devices are used to transmit or store VASI, documented permission must be obtained from their supervisor. In addition, the ISSO, IT Area Manager, or designee must approve and document that the mobile or portable storage device to be used meets VA’s security requirements, including that the device employs VA-approved encryption. Reference: VA OIS KS, Control Number AC-19, CCI-000082, CCI-000083, CCI-000084, CCI-002326, CCI-002329, CCI-002330, CCI-002331; Control Number AC-20, CCI-000097; Control Number SC-13, CCI-002449, CCI-002450 \nAdditionally, all VA mobile devices must be inventoried in the property accountability system, and the VA portable devices must be appropriately tracked/inventoried. References: VHA Handbook 7002 Part 8.5.b and VA Handbook 7002, Part 13, §10 "]
["51.","Select…","Are non-VA mobile or portable devices used for VA research?"]
[null,null,"This question pertains to non-VA devices that are used for sensitive and non-sensitive VA data. If so, current VA OIT current VA OIT policy requires the establishment and documentation of terms and conditions for the use of those devices, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing authorized individuals to process, store, and transmit VA-owned information using the external information system(s). Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336\n\nIf a non-VA mobile or portable device is used to transmit or store VASI, it must also employ VA approved encryption. References: VA Handbook 6500, §2.c and VA OIS KS, Control Number SC-13, CCI-002449, CCI-002450   "]
["52.","Select…","Are access contols applied to VA information on the VA network to ensure only appropriate staff have access to study-related data?  "]
[]
[null,null,"This would include VA data stored on shared drives on VA servers or in the VA cloud. Managements of permissions is often accomplished by restricting users’ access (either in security control groups or individually listed) to folders that contain the VA data.  Permissions management can be controlled by OIT or delegated to specific individuals (e.g., Research Service staff). In addition, the facility may have migrated to the use of the Shared Folder and File Exchange (SFFX) system to facilitate the management of folder permissions. Reference: VA OIS KS, Control Number AC-3, CCI-000213, CCI-002165 "]
["53.","Select…","Have any research-related Plan of Action and Milestones (POAMs) been established by OIT for identified information systems deficiencies in accordance with OIT policies? "]
[]
[null,null,"This would likely require consultation with the ISSO and/or Area Manager.  A POAM would be required, for example, if a VA information system cannot meet OIT baseline information security requirements to document the vulnerability and compensating controls.  Reference: VA OIS KS, Control Number CA-5, CCI-000264"]
["NOTES: Use the text box below to provide any additional information about items in the RISP section:"]
[]
[]
["Research Misconduct"]
["54. ","Select…","Has the VA facility Director appointed, in writing, an individual to serve as the Research Integrity Officer (RIO)? (NOTE: Research Integrity Officers are responsible for receiving allegations of research misconduct and providing facility-level oversight of the handling of such allegations.)"]
[]
[]
[]
[null,"Select…","a.  Are the name and contact information of the appointed RIO accurately recorded on this list of VHA RIOs posted on ORO’s website?"]
[]
[null,null,"If “No”, please contact Shara.Kabak@va.gov with current RIO name and appointment letter."]
["55.","Select…","Has the facility received any formal allegations of research misconduct (fabrication, falsification, or plagiarism) during this reporting period?"]
[]
["NOTES: Use the text box below to provide any additional information about items in the Research Misconduct section: "]

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[{"$f":"PartA!C2","v":"Select Facility…"}]
["PART B - RESEARCH PROGRAM QUANTITATIVE DATA"]
[]
["All questions in Part B refer to reporting period June 1, 2021 to May 31, 2022"]
[]
["RESEARCH AND DEVELOPMENT PROGRAM AND R&DC"]
["Note: Questions shaded in yellow are new questions from previous FDC versions."]
["Note: Questions #1-1a are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
[]
["1. ","Number of protocols followed only by the R&DC at any time during this reporting period (e.g., IRB-exempt human subjects protocols; protocols without human, animal, or safety hazards not followed by any research subcommittee):"]
[]
[]
[null,"a.  Number in #1 that were NOT initially approved by the R&DC before research was initiated:"]
[null,"Note: For answers greater than zero for item #1a, provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
[]
["HUMAN RESEARCH PROTECTION PROGRAM"]
["Note: Questions #2-#8 are not based on RCO audits and pertain to research conducted and events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["2.","Number of human subject protocols active (open) at any time during this reporting period:"]
[null,"Include Million Veteran Program (MVP) and All-of-Us in protocol count. Do not include research activities that are not subject to the Common Rule, such as expanded access protocols."]
[]
[null,"MVP is approved at site."]
[null,"All-of-Us is approved at site."]
["3. ","Number of protocols in #2:"]
[null,"a.  That were exempt from IRB oversight:"]
[null,"b.  That were nonexempt from IRB oversight:"]
[null,"Note: Items 3a + 3b should equal item #2."]
["4. ","Number of protocols in #3b for which the risk level was greater than minimal risk:"]
["5. ","Number of protocols in #3b:"]
[null,"a.  With informed consent waived per 38 CFR 16.116:"]
[null,"(This is the number of protocols for which the IRB has granted a waiver of informed consent for the study.)"]
[null,"b.  With documentation of informed consent waived per 38 CFR 16.117(c):"]
[null,"(This is the number of protocols for which the IRB has granted a waiver of documentation of informed consent for the study.)"]
[]
["6.","Number of protocols in #2:"]
[null,"a.  Subject to the 2018 Common Rule:"]
[null,"b.  Subject to the Pre-2018 Common Rule:"]
[null,"Note: Items 6a + 6b should equal item #2."]
["7.","Number of protocols suspended or terminated early by the IRB (for local reasons) due to the protocol not being conducted in accordance with applicable regulations, policies, agreements, or IRB requirements or due to concerns about the safety, rights, or welfare of human subjects or others:"]
[]
[]
[]
[null,"Do not include suspensions/terminations due to approval lapses or other administrative issues. \nDo not include suspensions due to the COVID-19 administrative hold."]
[]
[null,"Note: For answers greater than zero in item #7, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO: "]
[]
[]
["8.","Number of events determined by the IRB to constitute serious and/or continuing noncompliance:"]
[]
[null,"Do not include unanticipated problems involving risks to subjects or others (UPIRTSOs) or serious adverse events (SAEs) that are unrelated to noncompliance. VHA Directive 1058.01 §7.c(2) requires written notification to the VA Medical Facility Director, the RCO and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IRB."]
[]
[]
[]
[null,"Note: For answers greater than zero in item #8, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO: "]
[]
[]
[]
["Informed Consent Audits"]
["Note: Questions #9-#15 are based on RCO Informed Consent (IC) Audits for this reporting period. "]
["RCOs are required to conduct an IC audit on all active human subject protocols with the exception of protocols that have previously received at least one IC audit where the research is permanently closed to enrollment and all subjects have completed all research activities and the research remains active only for long-term follow-up of subject or the remaining research activities are limited to  data analysis.  "]
[]
[]
[]
["9.","Number of protocols in #2 receiving an informed consent audit:"]
["10.","Number of protocols in #2 NOT receiving an informed consent audit (auto-calculated from #2-#9):",{"$f":"C22-C67","v":0}]
[]
[null,"a.  Number of protocols in #10 that should have received an informed consent audit:"]
[null,"(This is the number of protocols that did NOT receive a REQUIRED informed consent audit.)"]
[null,"Note: For answers greater than zero in item #10a, please provide the ORO case number, if previously reported to ORO:"]
[]
[]
["11.","Total number of protocols receiving an informed consent audit (#9) that required IRB continuing review:"]
[]
[null,"a.  Number of protocols in #11 with a lapse in IRB continuing review:"]
[null,"b.  Number of protocols in #11a for which research activities occurred during lapse:"]
[null,"Do not count activities occurring during the approval lapse period that were authorized by the IRB to continue as in the best interests of already-enrolled subjects."]
[]
[null,"Note: For answers greater than zero in item #11b, please provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["12.","Total number of informed consent documents (ICDs) audited in all protocols:"]
[null,"(This is the total number of entries in the \"Subject ID\" column in the tool. MVP ICDs audited should be included in this count.)"]
[]
[null,"a.  Number of individual ICDs audited found to have no deficiencies:"]
[null,"(This is the number of ICDs with \"Y\" in the \"Correct Version,\" \"IRB-approved ICD,\" and \"ICD from Correct Study\" columns, and a \"N\" or \"N/A\" in all other ICD columns of the IC audit tool related to the ICD. Do not include deficiencies related to CPRS progress notes, HIPAA authorization deficiencies, or other deficiencies in local policy in this count.)"]
[]
[]
[null,"b.  Number of missing ICDs: "]
[null,"(This is the number of entries with \"N\" under \"ICD or Copy Found.\" Missing ICDs SHOULD be included in the count of total number of ICDs in item #12, but SHOULD NOT be included in counts for other deficiencies below.)"]
[]
[null,"Note: For answers greater than zero in item #12b, please provide details in the text box below or provide the ORO case number if previously reported to ORO. "]
[]
[]
[null,"c.  Number of ICDs with wrong version used:"]
[null,"(This is the number of entries with “N\" under \"Correct Version.\")"]
[null,"d.  Number of ICDs from another study used:"]
[null,"(This is the number of entries with “N” under “ICD from Correct Study.”)"]
[null,"e.  Number of unapproved ICDs used:  "]
[null,"(This is the number of entries with “N” under “IRB-approved.”)"]
[null,"Note: For answers greater than zero in items #12d and/or #12e, please provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
[null,"f.  Number of ICDs without a subject (or Legally Authorized Representative ) signature:"]
[null,"(This is the number of entries with “N” under “Subject Signature Present.”)"]
[null,"Note: For answers greater than zero in item #12f, please provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
[null,"g.  Number of ICDs without a subject date:"]
[null,"(This is the number of entries with “N” under “Date of Subject Signature Present.”)"]
["13.","Number of ICDs audited subject to the 2018 Common Rule Requirements:"]
[null,"a.  Number of ICDs in #13 without the required key information up front:"]
[null,"(This is the number entries with “N” under “Key Info Provided Up Front.”)"]
[null,"b.  Number of ICDs in #13 from protocols involving identifiable information or biospecimens:"]
[null,"(This is the number of entries with “Y” under “Identifiable Info/Biospecimens Collected.”)"]
[null,"c.  Number of ICDs in #13b without the required statement on future use of identifiable information or biospecimens:"]
[]
[null,"(This is the number of entries with “N” under “Information or Biospecimen Statement on Future Use.”)"]
[null,"d.  Number of ICDs in #13 requiring Broad Consent:"]
[null,"(This is the number of ICDs with \"Y\" or \"N\" under \"Broad Consent Signed\" and excludes all \"N/A\" entries.)"]
[null,"e.  Number of ICDs in #13d with for which broad consent was required but not obtained:"]
[null,"Note: For answers greater than zero in item #13e, please provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
["14.","Number of HIPAA authorizations required:"]
[null,"a.  Number of valid HIPAA authorizations not obtained (i.e., no HIPAA authorization or copy that could be located or HIPAA authorization missing signature or date):  "]
[]
[null,"(This is the number of HIPAA authorizations with “N” under \"Valid HIPAA Authorization Obtained.\")"]
[null,"Note: For answers greater than zero in item #14a, provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
[null,"b.  Number of HIPAA authorizations obtained that required use of VA Form 10-0493 (i.e., HIPAA authorizations not combined with the ICD):  "]
[]
[null,"[This is the number of entries with \"Y\" under \"VA Form 10-0493 Required (HIPAA Separate from ICD).” VA Form 10-0493 is required for all protocols approved between March 12, 2015 and January 20, 2019, and protocols approved on or after January 21, 2019 utilizing a separate HIPAA authorization document. Do not include MVP HIPAA authorizations in this count; MVP has a waiver from the requirement to use the VA Form 10-0493.]"]
[]
[]
[]
[null,"c.  Number of HIPAA authorizations in #14b not using VA Form 10-0493 as required:"]
[null,"(This is the number of entries with \"N\" under \"VA Form 10-0493 Used if Separate HIPAA Authorizations.\")"]
["15. ","Number of Veterans enrolled in the MVP during the reporting period:"]
[null,"(Only include enrollments from the main MVP; do not include enrollments in any MVP sub-studies.)"]
[null,"a.  Number of Veterans whose MVP ICD and HIPAA authorization were audited:  "]
[null,"(Items #15 and #15a are asked to ensure the requirement for auditing at least 10% of MVP ICDs has been met. The number of MVP ICDs audited should also be included in the count of ICDs audited in item #12 and the number of MVP HIPAA authorizations audited should be included in the count of HIPAA authorizations audited in item #14 above.)"]
[]
[]
[]
["Notes for ICD Section:"]
[]
[]
[]
["HRPP Regulatory Audits"]
["Note: Questions #16-#28 are based on RCO Regulatory Audits conducted for the current reporting period."]
["16. ","Total number of human subjects protocols receiving an HRPP regulatory audit for this period:"]
[null,"a.  Number of audited protocols in #16 that were greater than minimal risk:"]
[null,"b.  Number of protocols in #16a (greater than minimal risk protocols) that received initial approval by expedited review:"]
[]
[null,"Note:  For answers greater than zero for item #16b, please provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["17.","a.  Number of protocols audited in #16 initiated prior to required IRB approval:"]
[null,"b.  Number of protocols in #17a completed without required IRB approval:"]
[null,"c.  Number of protocols audited in #16 initiated prior to required R&DC approval:"]
[null,"d.  Number of protocols in #17c completed without required R&DC approval:"]
[null,"e.  Number of protocols in #16 initiated prior to receiving the ACOS/R letter:"]
[null,"Note: For answers greater than zero in items #17a-17e, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["18. ","Number of human subject protocols audited in #16 involving international research:"]
[null,"a.  Number of protocols in #18 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,"Note: For answers greater than zero in item #18a, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["19.","Number of human subject protocols audited in #16 involving children:"]
[null,"a.  Number of protocols in #19 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,"Note: For answers greater than zero in item #19a, provide details in the text box below or provide the ORO case number if previously reported to ORO: "]
[]
[]
["20.","Number of human subject protocols audited in #16 involving prisoners:"]
[null,"a.  Number of protocols in #20 that did not have documentation of CRADO approval:"]
[null,"Note: For answers greater than zero in item #20, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["21.","Number of protocols audited in #16 subject to the 2018 Common Rule requirements:"]
[null,"a.  Number of protocols in #21 that were IRB-exempt:"]
[null,"b.  Number of protocols in #21a with exempt category not documented:"]
[null,"(This is the number of protocols with “N” under “Exempt category documented.”)"]
[null,"c.  Number of protocols in #21a with incorrect exempt category:"]
[null,"(This is the number of protocols with “N” under “Does the exempt category determination appear to match the regulatory description of the category.”)"]
[]
[null,"Note: For answers greater than zero in items #21b or #21c, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
[null,"d.  Number of protocols in #21a requiring limited IRB review:"]
[null,"(This is the number of protocols with “Y” under “Did the protocol require a limited IRB review.”)"]
[null,"e.  Number of protocols in #21d not receiving required limited IRB review:"]
[null,"(This is the number of protocols with “N” under “Did the protocol receive a limited IRB review.”)"]
[null,"Note: For answers greater than zero in item #21e, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
[null,"f.  Number of protocols in #21a involving direct interaction with human subjects without provision for providing subjects required information:"]
[]
[null,"(This is the number of protocols with “N” under “Did the study documents include provisions for giving the subjects the information outlined in VHA Directive 1200.05(2) § 10.c.”)"]
[]
[null,"Note: For answers greater than zero in item #21f, provide details in the text box below:"]
[]
["22.","Number of protocols audited in #16 that required IRB continuing review per 1200.05(2):"]
["23.","Number of protocols audited in #16 not requiring IRB continuing review per 1200.05(2) but continuing review was required by the IRB:"]
[]
["24.","a.  Number of protocols in #22 or #23 with a lapse of IRB continuing review:"]
[null,"(This is the number of protocols with \"N\" under \"If CR was required by either 1200.05(2) or the IRB, did CR occur as scheduled.\")"]
[]
[null,"b.  Number in #24a for which research activities occurred during lapse:"]
[null,"Do not count research activities occurring during the approval lapse period that were authorized by the IRB to continue in the best interests of already-enrolled subjects."]
[]
[null,"Note: For answers greater than zero in item #24b, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
[null,"c.  Number in #23 with rationale for IRB-required continuing review not documented:"]
[null,"Note: For answers greater than zero in item #24c, provide details in the text box below:"]
[]
["25.","Number of 2018 Common Rule protocols audited (#21) subject to the single IRB requirement:"]
[null,"a.  Number in #25 reviewed by a single IRB:"]
[null,"b.  Number in #25a without a valid reliance agreement in place between the single IRB and the facility:"]
[]
[null,"c.  Number in #25 not reviewed by a single IRB:"]
[null,"d.  Number in #25c without a valid exception granted by the VHA ORD or another Federal entity supporting or conducting the research, as appropriate:"]
[]
[null,"Note: For answers greater than zero in item #25b or #25d, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["26.","For those protocols receiving an HRPP regulatory audit (#16), what was the total number of apparent unanticipated problems involving risks to subjects or others (UPIRTSOs) (including serious adverse events) reported to the IRB:"]
[]
[]
[null,"a.  Number of events in #26 that were determined by the IRB to constitute actual UPIRTOs (unexpected, related or possibly related to the research, and placing subjects or others at substantively greater risk):"]
[]
[null,"b.  Number of UPIRTSOs in #26a not reported to the IRB within the required time period:"]
[]
[null,"c.  Number of UPIRTSOs in #26a not reviewed and categorized by the IRB within the required time period:"]
[]
[null,"Note: For answers greater than zero in item #26b or #26c, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["27.","Total number of research personnel records audited as part of the HRPP regulatory audits in #16:"]
[]
[null,"a.  Number of research personnel records in #27 with lapse in required human research training:"]
[]
[null,"(This is the number of records with “N” under “All Human Research Training Current.”)"]
[null,"b.  Number of research personnel records in #27 without initial training:"]
[null,"(This is the number of records with “N” under “Initial Human Research Training Completed.”)"]
[null,"Note: For answers greater than zero in item #27b, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["28.","Total number of subject records reviewed as part of the HRPP regulatory audits in #16 for this period:"]
[]
[null,"(Subject records review can be found on page 6 of the HRPP audit tool.)"]
[null,"a.  Number of subjects in #28 with research initiated prior to consent:   "]
[null,"(This is the number of subject records with an “N” under “Documentation that consent obtained prior to initiation of study procedures.”)"]
[]
[null,"Note: For answers greater than zero in item #28a, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
[null,"b.  Number of subject records in #28 for which application of inclusion/exclusion criteria were audited:"]
[]
[null,"(Auditing of inclusion/exclusion criteria is only required for research involving intervention or interaction with subjects determined to be more than minimal risk by the IRB.)"]
[]
[null,"c.  Number of subjects in #28b included in research without satisfying inclusion/exclusion criteria:"]
[]
[null,"(This is the number of subject records with a “Y” under “Subject included in research not meeting inclusion/exclusion criteria.\")"]
[]
[null,"Note: For answers greater than zero in item #28c, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["Notes for HRPP/IRB Section: "]
[]
[]
[]
["ANIMAL CARE AND USE PROGRAM AND IACUC"]
[null,"If your program does not have an ACUP, skip questions #29-#36b."]
[]
["Note: Questions #29-#31 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["29.","Total number of animal protocols active (open) at any time during this reporting period:"]
["30.","Number of protocols that were suspended or terminated early by the IACUC due to the study not being conducted in accordance with applicable regulatory, policy, or IACUC requirements or due to animal or research personnel welfare concerns:"]
[]
[]
[null,"Note: If not yet reported to ORO, provide details for suspensions including species and associated corrective actions (if applicable) in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
[]
["31.","Number of events determined by the IACUC to constitute serious and/or continuing noncompliance:"]
[]
[null,"(VHA Directive 1058.01 §9.d(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IACUC.)"]
[]
[null,"Note: For answers greater than zero in item #31, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO:"]
[]
[]
["Animal Welfare Audits"]
["Note: Questions #32-#36b are based on RCO Regulatory Audits conducted for this reporting period."]
["32.","Total number of protocols receiving animal welfare regulatory audits during the reporting year:"]
[]
["33.","Number of protocols audited in #32 involving DEA controlled substances:"]
[null,"a.  Number of protocols in #33 conducted at the VA:"]
[null,"b.  Number of protocols in #33a with DEA controlled substances not obtained through the VA pharmacy:"]
[]
[null,"(This is the number of protocols with \"N\" under \"Controlled substances are obtained through the VA Pharmacy.\")"]
[null,"Note: For answers greater than zero in item #33b, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
[null,"c.  Number of protocols in #33a with controlled substances not properly stored:"]
[null,"(This is the number of protocols with “N” under “Controlled substances stored in a double-locked cabinet and accessible only to authorized personnel.”)"]
[]
[null,"Note: For answers greater than zero in item #33c, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["34.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,"a.  Number of protocols audited in #32 initiated prior to IACUC approval:"]
[null,"b.  Number of protocols in #34a completed prior to IACUC approval:"]
[null,"c.  Number of protocols audited in #32 initiated prior to R&DC approval:"]
[null,"d.  Number of protocols in #34c completed prior to R&DC approval:"]
[null,"e.  Number of protocols in #32 initiated prior to receiving the ACOS/R letter:"]
[null,"Note: If not yet reported to ORO, provide details for research initiated or completed prior to committee approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
[]
["35.","Number of protocols audited in #32 that required at least one IACUC annual review:"]
[null,"a.  Number of protocols in #35 with a lapse in annual review:"]
[null,"b.  Number of protocols audited in #32 that required a triennial review:"]
[null,"c.  Number of protocols in #35b with a lapse(s) in triennial review:"]
[null,"d.  Number of protocols in #35c in which research activities continued during the lapse in triennial review:"]
[]
[null,"Note:  If not yet reported to ORO, provide details for lapses in triennial reviews including species information in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
[]
["36.","Total number of research personnel records audited as part of the animal welfare audits in #32:"]
[]
[null,"a.  Total number of research personnel records in #36 with lapse in required continuing animal welfare training:"]
[]
[null,"(This is the number of records with “N” under “All Animal Welfare Training Current.”)"]
[null,"b.  Number of research personnel records in #36 without initial animal welfare training:"]
[null,"(This is the number of records with “N” under “Initial Animal Welfare Training Completed.”)"]
[null,"Note: For answers greater than zero in item #36b, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["Notes for ACUP/IACUC Section: "]
[]
[]
[]
["RESEARCH SAFETY AND SECURITY PROGRAM AND SRS"]
["If your program does not have research involving biological, chemical, physical, or radiation hazards, \nskip questions #37-#46b."]
[]
["Note: Questions #37-#39 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
["37.","Total number of safety protocols active (open) at any time during this reporting period:     "]
[null,"a.  Number of protocols in #37 with no IRB or IACUC approval components (i.e., only basic science, bench, or wet lab protocols):"]
[]
["38.","Number of protocols in #37 suspended or terminated early by the SRS due to research laboratory safety or security concerns, including concerns about the safety of individuals conducting VA laboratory research, or environmental concerns attributed to VA laboratory research:"]
[]
[]
[]
[null,"Note:  If not yet reported to ORO, provide details for suspensions in the text box below.  If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
["39.","Number of events determined by the SRS to constitute serious and/or continuing noncompliance:"]
[]
[null,"(VHA Directive 1058.01 §10.c(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the SRS.)"]
[]
[null,"Note: For answers greater than zero in item #39, provide details in the text box below or provide the ORO case number(s) if previously reported to ORO:"]
[]
[]
["Research Safety Audits"]
["Note: Questions #40-#46b are based on RCO Regulatory Audits conducted for this reporting period. "]
["40.","Number of protocols receiving a Research Safety regulatory audit during the reporting period:"]
[]
["41.","Number of protocols audited in #40 conducted completely or partially at an off-site location:"]
[null,"a.  Number of protocols in #41 with \"No\" in \"off-site waiver approved\":"]
["42.","Number of protocols audited in #40 involving chemical hazards:"]
[null,"a.  Number of protocols in #42 without required semi-annual laboratory chemical inventory review:"]
[]
[null,"(This is the number of protocols with \"N\" in \"was the laboratory chemical inventory reviewed semi-annually.”)"]
["43.","Number of protocols audited in #40 involving radioisotopes or radiation sources:"]
[null,"a.  Number of protocols in #43 without required review by the Radiation Safety Officer or Research Safety Coordinator:"]
[]
[null,"(This is the number of protocols with \"N\" in \"protocol reviewed by the Radiation Safety Officer or Research Safety Coordinator.\")"]
[]
["44.","a.  Number of protocols audited in #40 initiated prior to SRS approval:"]
[null,"b.  Number of protocols in #44a completed prior to SRS approval:"]
[null,"c.  Number of protocols in #40 without appropriate written notification of outcome of SRS review:"]
[]
[null,"(This is the number of protocols with “N” in “investigator appropriately notified in writing or electronically of the outcome of the IBC’s review.”)"]
[]
[null,"d.  Number of protocols audited in #40 initiated without required R&DC approval:"]
[null,"e.  Number of protocols in #44d completed without required R&DC approval:"]
[null,"f.  Number of protocols in #40 initiated prior to receiving the ACOS/R letter:"]
[null,"Note: If not yet reported to ORO, provide details for research initiated or completed prior to committee approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
[]
["45.","Number of protocols audited in #40 involving use of non-exempt rDNA requiring IBC approval:"]
[]
[null,"a.  Number of protocols in #45 initiated prior to IBC approval:"]
[null,"b.  Number of protocols in #45a completed prior to IBC approval:"]
[null,"c.  Number of protocols in #45 without appropriate notification of IBC review:"]
[null,"(This is the number of protocols with “N” in “investigator appropriately notified in writing or electronically of the outcome of the IBC’s review.”)"]
[]
[null,"Note: If not yet reported to ORO, provide details for research initiated or completed prior to IBC approval in the text box below. If previously reported to ORO, provide the ORO case number (if an ORO case number is provided, no additional information is necessary):"]
[]
[]
[]
["46.","Total number of research personnel records audited as part of the research safety audits in #40:"]
[]
[null,"a.  Total number of research personnel records in #46 with lapse in required continuing research safety training:"]
[]
[null,"(This is the number of research personnel records with an “N” under “All Safety Training Current.”)"]
[null,"b.  Number of research personnel records in #46 without initial research safety training:"]
[null,"(This is the number of personnel records with a “N” under “Initial Safety Training Completed.”)"]
[null,"Note: For answers greater than zero in item #46b, provide details in the text box below or provide the ORO case number if previously reported to ORO:"]
[]
[]
["Notes for RSSP/SRS Section:"]

{"sheet":"Director Attestation","index":2,"n_rows":16,"n_cols":1,"rows_kept":16,"cut":false,"hidden":false,"merged":[[12,0,12,9],[13,0,13,9],[14,0,14,9],[15,0,15,9],[1,0,1,9],[0,0,0,9],[2,0,2,2],[3,0,4,9],[6,0,7,9],[9,0,9,3],[9,4,9,9]]}
[{"$f":"PartA!C2","v":"Select Facility…"}]
["Facility Director Attestation"]
[]
["I acknowledge that I am the Director of this VHA Facility and the Institutional Official responsible for this Facility’s compliance with all federal, VA, and VHA research requirements.  "]
[]
[]
["By submitting this document, I certify that the information contained in this document is accurate to the best of my knowledge."]
[]
[]
["Signature of the Medical Facility Director:"]
[]
[]
["Complete the following steps to submit this Certification:"]
["1. Enter your name in the \"Signature of the Medical Facility Director\" text box above."]
["2. Save the file by clicking the \"Save File\" button below."]
["3. Email the file using the \"Email File\" button below."]

{"sheet":"FDC Instructions","index":3,"n_rows":61,"n_cols":1,"rows_kept":61,"cut":false,"hidden":false,"merged":[[59,0,59,9],[60,0,60,9],[46,0,49,9],[50,0,51,9],[54,0,55,9],[56,0,58,9],[36,0,36,9],[45,0,45,9],[32,0,33,9],[37,0,38,9],[39,0,40,9],[41,0,42,9],[43,0,44,9],[20,0,21,9],[22,0,23,9],[24,0,25,9],[26,0,27,9],[28,0,31,9],[1,0,2,9],[3,0,5,9],[7,0,8,9],[11,0,13,9],[18,0,19,9],[6,0,6,9],[9,0,9,9],[10,0,10,9],[14,0,14,9],[17,0,17,9]]}
["GENERAL INSTRUCTIONS"]
["1. The 2022 Facility Director’s Certification of Research Oversight (FDC) must be completed and submitted in MS Excel format.  "]
[]
["2. The tool must be saved as a macro-enabled workbook (.xlsm) so that all functions in the tool work as intended. The tool has built-in logic that will hide or gray out certain questions and rows depending on the answers to other questions. "]
[]
[]
["3. Include your facility's name in the file name of the saved document."]
["4. Do not separate individual Worksheets from the overall Workbook for completion. The tool must remain as a single Workbook so that all functions work as intended. "]
[]
["5. The tab key can be used to navigate through the items requiring a response on each Worksheet. "]
["6. Do not include any identifiable information, such as subject or investigator names, in the tool."]
["7. To print a copy of the tool, highlight the Worksheets that you could like to print by pressing Ctrl and clicking on the Worksheet tab. Under print options, ensure \"Print Active Sheets\" is selected. You can also choose to \"Print the Entire Workbook.\""]
[]
[]
["8. Any questions related to the 2022 FDC should be sent to OROIDA@va.gov."]
[]
["PART A"]
["1. Only the designated dropdowns and text boxes can be used to respond."]
["2. For dropdowns, click in the light green box and the dropdown arrow will become visible. Select the appropriate response from the options shown. "]
[]
["3. Text boxes will appear bright yellow when a response is required based on the selection in the drop-down menu. The text box will turn white once the required response has been entered."]
[]
["4. To enter information into a text box, click in the box and begin typing a response. The shading will disappear once a response is entered. To paste text into the text box, double click on the text box first. "]
[]
["5. Throughout the tool, the red font text provides additional clarification or asks for additional information. The blue font text helps you navigate to the next applicable question.  "]
[]
["6. Some rows with questions that are not applicable to your site (based on prior responses) will become hidden. The blue font instructions will help guide you to the next applicable question. "]
[]
["7. Designated text boxes are available at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers indicating outstanding noncompliance.  All notes sections will expand as you type in text. If you want to paste text into any of the tan text boxes, double click on the text box first. "]
[]
[]
[]
["8. Response boxes will turn white once completed. Once responses are entered, you can scan through the tool to ensure there are no remaining colored cells that need to be completed. "]
[]
[]
["PART B"]
["1. Whole number responses should be entered into the gray response boxes. "]
["2. Tan boxes for text responses will turn bright yellow when more information is required based on a prior response. The text box will turn white once the required response has been entered. "]
[]
["3. To enter information into a text box, click in the box and begin typing a response. The shading will disappear once a response is entered. To paste text into the text box, double click on the text box first. "]
[]
["4. Items will turn gray and response boxes will disappear if you do not need to respond to that item based on your prior responses. "]
[]
["5. Response boxes will turn bright yellow with red font text if a response is entered that is inconsistent with other information that you previously entered into the tool."]
[]
["6. Data validation prompts will also help you to identify potential data entry errors."]
["7. Designated text boxes are available at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers indicating outstanding noncompliance.  All notes sections will expand as you type in text. If you want to paste text into any of the tan text boxes, double click on the text box first. "]
[]
[]
[]
["8. Response boxes will turn white once completed. Once responses are entered, you can scan through the tool to ensure there are no remaining colored cells that need to be completed. "]
[]
[]
["SUBMISSION"]
["1. The Medical Facility Director must sign (print name) on the Director Attestation tab. An electronic signature is not required."]
[]
["2. The Medical Facility Director should then save a copy of the completed tool by clicking on the “Save File” button on the Director Attestation tab. Make sure the facility's name is in the file name of the saved document. "]
[]
[]
["3. After saving the file, the Medical Facility Director should click on the “Email File” button. "]
["4. The FDC must be submitted by the Medical Facility Director. "]

{"sheet":"ExportA","index":4,"n_rows":219,"n_cols":6,"rows_kept":219,"cut":false,"hidden":true,"merged":[]}
["Question#","QuestionText","id-facility","id-question","FDCdate","FDCresult"]
["1","Adequate Resources",{"$f":"LEFT(PartA!C2,FIND(\" \",PartA!C2,1)-1)","v":"Select"},"FD2","2022-07-31",{"$f":"PartA!B14","v":"Select…"}]
["1_detail","DETAILS Adequate Resources",{"$f":"C2","v":"Select"},"FD20","2022-07-31",{"$f":"IF(PartA!C18=\"\",\"\",PartA!C18)","v":""}]
["2a","R&DC Appointed in Writing",{"$f":"C3","v":"Select"},"FD9","2022-07-31",{"$f":"PartA!B21","v":"Select…"}]
["2b","Delegated Roles","Select","FD1","2022-07-31",{"$f":"PartA!B23","v":"Select…"}]
["3a","RCO Audit Plan","Select","FD6","2022-07-31",{"$f":"PartA!B27","v":"Select…"}]
["3b","Audits Completed","Select","FD7","2022-07-31",{"$f":"PartA!$B$30","v":"Select…"}]
["3b_detail","DETAILS Audits Not Completed","Select","FD11","2022-07-31",{"$f":"IF(PartA!C33=\"\",\"\",PartA!C33)","v":""}]
["4","Any Acting Position(s)","Select","FD3","2022-07-31",{"$f":"PartA!B34","v":"Select…"}]
["4_acting_detail","DETAILS Acting Positions","Select","FD21","2022-07-31",{"$f":"IF(PartA!C43=\"\",\"\",PartA!C43)","v":""}]
["4_FD","Acting Facility Director","Select","FD12","2022-07-31",false]
["4_ACOS","Acting ACOS/Research or Coordinator","Select","FD14","2022-07-31",false]
["4_AO","Acting Administrative Officer/Research","Select","FD15","2022-07-31",false]
["4_RCO","Acting Research Compliance Officer","Select","FD16","2022-07-31",false]
["4_CC","Acting Research Committee Coordinator(s)","Select","FD17","2022-07-31",false]
["4_CC_detail","Acting Committee Coordinator details","Select","FD18","2022-07-31",{"$f":"IF(PartA!C41=\"\",\"\",PartA!C41)","v":""}]
["4a","CRADO Approval for Acting ACOS/R","Select","FD22","2022-07-31",{"$f":"PartA!B44","v":"Select…"}]
["FDNotes","Facility Director Section Notes","Select","FD8","2022-07-31",{"$f":"IF(PartA!C49=\"\",\"\",PartA!C49)","v":""}]
["5","Another VA R&DC","Select","RD29","2022-07-31",{"$f":"PartA!B52","v":"Select…"}]
["5_detail","DETAILS Another VA R&DC","Select","RD30","2022-07-31",{"$f":"IF(PartA!C53=\"\",\"\",PartA!C53)","v":""}]
["6a","Committees Reviewed Annually, Reported to FD","Select","RD18","2022-07-31",{"$f":"PartA!B56","v":"Select…"}]
["6b","Subcommittee Minutes Review within 60 Days","Select","RD19","2022-07-31",{"$f":"PartA!B59","v":"Select…"}]
["6c","Subcommittee Approval before R&DC Approval","Select","RD20","2022-07-31",{"$f":"PartA!B62","v":"Select…"}]
["6d","External IRB Meets Requirements","Select","RD21","2022-07-31",{"$f":"PartA!B65","v":"Select…"}]
["6e","Approval of Research Not Assigned to Committees","Select","RD22","2022-07-31",{"$f":"PartA!B70","v":"Select…"}]
["6f","Only VA Research for Collaborative Studies","Select","RD23","2022-07-31",{"$f":"PartA!B73","v":"Select…"}]
["6g","Approval for Recruitment of Non-Veterans","Select","RD24","2022-07-31",{"$f":"PartA!B75","v":"Select…"}]
["6h","ISSO and PO review","Select","RD36","2022-07-31",{"$f":"PartA!B77","v":"Select…"}]
["7","Privacy Review Checklist and ERDSP","Select","RD31","2022-07-31",{"$f":"PartA!B81","v":"Select…"}]
["8a","ACOS Notification to PI","Select","RD16","2022-07-31",{"$f":"PartA!B86","v":"Select…"}]
["8b","Research Personnel Hold VA Appointment","Select","RD25","2022-07-31",{"$f":"PartA!B90","v":"Select…"}]
["8c","WOC Appointments in Place","Select","RD26","2022-07-31",{"$f":"PartA!B95","v":"Select…"}]
["9a","Protocol Tracking Systems","Select","RD8","2022-07-31",{"$f":"PartA!B100","v":"Select…"}]
["9a_detail","Protocol Tracking Name","Select","RD9","2022-07-31",{"$f":"IF(PartA!C105=\"\",\"\",PartA!C105)","v":""}]
["9b","Tracking of Committee Actions","Select","RD32","2022-07-31",{"$f":"PartA!B106","v":"Select…"}]
["9c","Tracking of Written Agreements","Select","RD33","2022-07-31",{"$f":"PartA!B109","v":"Select…"}]
["9d","Tracking of Research Personnel","Select","RD34","2022-07-31",{"$f":"PartA!B113","v":"Select…"}]
["9e","Tracking of Training","Select","RD27","2022-07-31",{"$f":"PartA!B117","v":"Select…"}]
["9f(1)","Tracking of Research Data (Repository)","Select","RD35","2022-07-31",{"$f":"PartA!B121","v":"Select…"}]
["9f(2)","Tracking of Research Data (RCS)","Select","RD37","2022-07-31",{"$f":"PartA!B122","v":"Select…"}]
["RDCNotes","FD/RDC Section Notes","Select","RD17","2022-07-31",{"$f":"IF(PartA!C127=\"\",\"\",PartA!C127)","v":""}]
["10a","Internal (Local) IRB","Select","IR1","2022-07-31",{"$f":"PartA!B131","v":"Select…"}]
["10b","External (Academic Affiliate) IRB","Select","IR2","2022-07-31",{"$f":"PartA!B133","v":"Select…"}]
["10b_detail","Academic Affiliate Detail","Select","IR3","2022-07-31",{"$f":"IF(PartA!C135=\"\",\"\",PartA!C135)","v":""}]
["10c","Other VA IRB","Select","IR4","2022-07-31",{"$f":"PartA!B136","v":"Select…"}]
["10c_detail","Other VA IRB Detail","Select","IR5","2022-07-31",{"$f":"IF(PartA!C138=\"\",\"\",PartA!C138)","v":""}]
["11a","IRB Minutes Document Approval Criteria","Select","IR86","2022-07-31",{"$f":"PartA!B140","v":"Select…"}]
["11b","ICDs with All Required Elements","Select","IR87","2022-07-31",{"$f":"PartA!B143","v":"Select…"}]
["11c","IC Waivers Reviewed and Documented","Select","IR88","2022-07-31",{"$f":"PartA!B145","v":"Select…"}]
["11d","HIPAA Authorizations Waivers Reviewed and Documented","Select","IR89","2022-07-31",{"$f":"PartA!B148","v":"Select…"}]
["12a","2018 CR Exempt Research and Limited IRB Review","Select","IR90","2022-07-31",{"$f":"PartA!B153","v":"Select…"}]
["12b","2018 CR Continuing Review and Documentation of Rationale","Select","IR91","2022-07-31",{"$f":"PartA!B156","v":"Select…"}]
["12c","2018 CR Min Risk Documentation","Select","IR45","2022-07-31",{"$f":"PartA!B161","v":"Select…"}]
["12d","2018 CR ICDs Contain New Requirements","Select","IR46","2022-07-31",{"$f":"PartA!B165","v":"Select…"}]
["12e","ICD Posted","Select","IR48","2022-07-31",{"$f":"PartA!B169","v":"Select…"}]
["13","2018 CR Broad Consent Allowed","Select","IR92","2022-07-31",{"$f":"PartA!B174","v":"Select…"}]
["13a","2018 CR Broad Consent on Specimens Collected for Research","Select","IR47","2022-07-31",{"$f":"PartA!B175","v":"Select…"}]
["13b","2018 CR Broad Consent Approved","Select","IR96","2022-07-31",{"$f":"PartA!B179","v":"Select…"}]
["14","Secondary IRBs (Yes/No)","Select","IR6","2022-07-31",{"$f":"PartA!B181","v":"Select…"}]
["14_CIRB","VA Central IRB","Select","IR67","2022-07-31",false]
["14_NCI","National Cancer Institute (NCI) IRB","Select","IR68","2022-07-31",false]
["14_AOU","NIH All of Us IRB","Select","IR60","2022-07-31",false]
["14_Advarra","Advarra, Inc. IRB","Select","IR83","2022-07-31",false]
["14_OakRidge","Oak Ridge Associated Universities IRB","Select","IR85","2022-07-31",false]
["14_Sterling","Sterling IRB","Select","IR84","2022-07-31",false]
["14_WCG IRB","WCG IRB","Select","IR82","2022-07-31",false]
["15","Other IRB(s)","Select","IR76","2022-07-31",{"$f":"PartA!B191","v":"Select…"}]
["15_detail","DETAILS Other IRB",{"$f":"C67","v":"Select"},"IR77","2022-07-31",{"$f":"IF(PartA!C193=\"\",\"\",PartA!C193)","v":""}]
["15a","DETAILS Other IRB ORD Approval","Select","IR78","2022-07-31",{"$f":"PartA!B194","v":"Select…"}]
["16","IRB Reliance Agreement","Select","IR80","2022-07-31",{"$f":"PartA!B196","v":"Select…"}]
["17","Single IRB Review of Cooperative Research","Select","IR81","2022-07-31",{"$f":"PartA!B202","v":"Select…"}]
["18","OHRP FWA","Select","IR13","2022-07-31",{"$f":"PartA!B212","v":"Select…"}]
["18_detail","FWA exp date","Select","IR64","2022-07-31",{"$f":"IF(PartA!C215=\"\",\"\",PartA!C215)","v":""}]
["19a","IRB/HRPP SOPs (Review of Research)","Select","IR17","2022-07-31",{"$f":"PartA!B219","v":"Select…"}]
["19b","Transition to 2018 CR SOP","Select","IR40","2022-07-31",{"$f":"PartA!B221","v":"Select…"}]
["19c","HRPP SOP for Review and Reporting UPIRTSOs and Serious Noncompliance","Select","IR93","2022-07-31",{"$f":"PartA!B224","v":"Select…"}]
["20","PO Review of HIPAA Authorizations","Select","IR49","2022-07-31",{"$f":"PartA!B229","v":"Select…"}]
["21","Investigational Drugs","Select","IR23","2022-07-31",{"$f":"PartA!B234","v":"Select…"}]
["21a","New Drug Application (IND)","Select","IR50","2022-07-31",{"$f":"PartA!B236","v":"Select…"}]
["21b","Cellular Therapy or Human Gene Therapy","Select","IR51","2022-07-31",{"$f":"PartA!B238","v":"Select…"}]
["21c","Process for IBC Review","Select","IR94","2022-07-31",{"$f":"PartA!B240","v":"Select…"}]
["21d","Inv Drugs Stored Outside VA Pharmacy","Select","IR52","2022-07-31",{"$f":"PartA!B245","v":"Select…"}]
["21d_detail","DETAILS Inv Drugs Storage","Select","IR53","2022-07-31",{"$f":"IF(PartA!C248=\"\",\"\",PartA!C248)","v":""}]
["21e","Delegation of Custody","Select","IR54","2022-07-31",{"$f":"PartA!B249","v":"Select…"}]
["21f","Controlled Substances","Select","IR26","2022-07-31",{"$f":"PartA!B251","v":"Select…"}]
["21g","Controlled Substance Storage","Select","IR27","2022-07-31",{"$f":"PartA!B253","v":"Select…"}]
["21h","Controlled Substance Inspections","Select","IR28","2022-07-31",{"$f":"PartA!B256","v":"Select…"}]
["22","Investigational Device Exemption (IDE)","Select","IR55","2022-07-31",{"$f":"PartA!B259","v":"Select…"}]
["22a","Significant Risk Devices","Select","IR56","2022-07-31",{"$f":"PartA!B261","v":"Select…"}]
["22b","IDE Approval from FDA","Select","IR95","2022-07-31",{"$f":"PartA!B262","v":"Select…"}]
["23","Pregnant Women, Fetuses, Neonates","Select","IR58","2022-07-31",{"$f":"PartA!B265","v":"Select…"}]
["23a","Pregnant Women Research Certifications/Approvals","Select","IR59","2022-07-31",{"$f":"PartA!B267","v":"Select…"}]
["HRPPNotes","HRPP Section Notes","Select","IR34","2022-07-31",{"$f":"IF(PartA!C271=\"\",\"\",PartA!C271)","v":""}]
["24","Animal Program","Select","IA1","2022-07-31",{"$f":"PartA!B274","v":"Select…"}]
["25","Internal (Local) IACUC","Select","IA2","2022-07-31",{"$f":"PartA!B278","v":"Select…"}]
["25a","IACUC Chair Appointed","Select","IA82","2022-07-31",{"$f":"PartA!B282","v":"Select…"}]
["25b","Required IACUC Members Appointed","Select","IA83","2022-07-31",{"$f":"PartA!B284","v":"Select…"}]
["26","Academic Affiliate IACUC (in lieu of VA IACUC)","Select","IA51","2022-07-31",{"$f":"PartA!B287","v":"Select…"}]
["26_detail","Academic Affiliate IACUC (in lieu of VA IACUC) Detail","Select","IA52","2022-07-31",{"$f":"IF(PartA!C290=\"\",\"\",PartA!C290)","v":""}]
["26a","VMO/VMC and Scientist Appointed to Affiliate","Select","IA84","2022-07-31",{"$f":"PartA!B291","v":"Select…"}]
["26b","Academic Affiliate IACUC (in lieu of VA IACUC) MOU","Select","IA53","2022-07-31",{"$f":"PartA!B295","v":"Select…"}]
["27","Additional Affiliate IACUC","Select","IA54","2022-07-31",{"$f":"PartA!B297","v":"Select…"}]
["27_detail","Additional Affiliate IACUC Detail","Select","IA55","2022-07-31",{"$f":"IF(PartA!C299=\"\",\"\",PartA!C299)","v":""}]
["27a","MOU for Shared Oversight","Select","IA9","2022-07-31",{"$f":"PartA!B300","v":"Select…"}]
["28","AAALAC Accreditation Status","Select","IA14","2022-07-31",{"$f":"PartA!C306","v":"Select…"}]
["28a","Date of Accreditation Determination Letter","Select","IA15","2022-07-31",{"$f":"IF(PartA!C308=\"\",\"\",PartA!C308)","v":""}]
["29","USDA Registration","Select","IA16","2022-07-31",{"$f":"PartA!B309","v":"Select…"}]
["30","Non USDA-Regulated Species","Select","IA72","2022-07-31",{"$f":"PartA!B310","v":"Select…"}]
["30_detail","DETAILS Non USDA-regulated species","Select","IA73","2022-07-31",{"$f":"IF(PartA!C313=\"\",\"\",PartA!C313)","v":""}]
["31","Use of USDA Regulated Species","Select","IA17","2022-07-31",{"$f":"PartA!B314","v":"Select…"}]
["31a","Dogs","Select","IA18","2022-07-31",{"$f":"PartA!B316","v":"Select…"}]
["31a_detail","Dogs Housed","Select","IA19","2022-07-31",{"$f":"IF(PartA!C317=\"\",\"\",PartA!C317)","v":""}]
["31a1","Dog Research Funded by VA","Select","IA56","2022-07-31",{"$f":"PartA!B318","v":"Select…"}]
["31a2","Dog Research Approved by VA Secretary","Select","IA70","2022-07-31",{"$f":"PartA!B319","v":"Select…"}]
["31b","Cats","Select","IA20","2022-07-31",{"$f":"PartA!B321","v":"Select…"}]
["31b_detail","Cats Housed","Select","IA21","2022-07-31",{"$f":"IF(PartA!C322=\"\",\"\",PartA!C322)","v":""}]
["31b1","Cat Research Funded by VA","Select","IA79","2022-07-31",{"$f":"PartA!B323","v":"Select…"}]
["31b2","Cat Research Approved by VA Secretary","Select","IA74","2022-07-31",{"$f":"PartA!B324","v":"Select…"}]
["31c","Non-Human Primates","Select","IA22","2022-07-31",{"$f":"PartA!B326","v":"Select…"}]
["31c_detail","Non-Human Primates Housed","Select","IA23","2022-07-31",{"$f":"IF(PartA!C328=\"\",\"\",PartA!C328)","v":""}]
["31c1","NHP Research Funded by VA","Select","IA80","2022-07-31",{"$f":"PartA!B329","v":"Select…"}]
["31c2","NHP Research Approved by VA Secretary","Select","IA75","2022-07-31",{"$f":"PartA!B330","v":"Select…"}]
["31d","Swine","Select","IA57","2022-07-31",{"$f":"PartA!B332","v":"Select…"}]
["31d_detail","Swine Housed","Select","IA58","2022-07-31",{"$f":"IF(PartA!C333=\"\",\"\",PartA!C333)","v":""}]
["31e","Rabbit","Select","IA59","2022-07-31",{"$f":"PartA!B334","v":"Select…"}]
["31e_detail","Rabbit Housed","Select","IA60","2022-07-31",{"$f":"IF(PartA!C335=\"\",\"\",PartA!C335)","v":""}]
["31f","Other USDA","Select","IA24","2022-07-31",{"$f":"PartA!B336","v":"Select…"}]
["31f_detail","Other USDA Housed","Select","IA25","2022-07-31",{"$f":"IF(PartA!C337=\"\",\"\",PartA!C337)","v":""}]
["32","Animals Housed","Select","IA7","2022-07-31",{"$f":"PartA!C339","v":"Select…"}]
["33a","VA Animal Facility HVAC","Select","IA61","2022-07-31",{"$f":"PartA!B343","v":"Select…"}]
["33b","VA Animal Facility Reheat Coils Fail-Safe","Select","IA62","2022-07-31",{"$f":"PartA!B346","v":"Select…"}]
["33c","Overheat Tests Conducted and Reviewed",{"$f":"C131","v":"Select"},"IA76","2022-07-31",{"$f":"PartA!B349","v":"Select…"}]
["33d","VA Animal Facility Access","Select","IA63","2022-07-31",{"$f":"PartA!B353","v":"Select…"}]
["33e","VA Animal Facility Emergency Power","Select","IA64","2022-07-31",{"$f":"PartA!B355","v":"Select…"}]
["34","VA ACUP Review and Facility Inspection","Select","IA71","2022-07-31",{"$f":"PartA!C358","v":"Select…"}]
["34a","VA ACUP Semi-Annual Program Evaluations","Select","IA32","2022-07-31",{"$f":"PartA!B359","v":"Select…"}]
["34b","VA ACUP Semi-Annual Facility Inspections","Select","IA33","2022-07-31",{"$f":"PartA!B361","v":"Select…"}]
["34b_detail","OLAW Waiver","Select","IA85","2022-07-31",{"$f":"PartA!B363","v":"Select…"}]
["34c","VA ACUP  Director Briefed","Select","IA34","2022-07-31",{"$f":"PartA!B364","v":"Select…"}]
["34d","VA ACUP Semi-Annual Reports Contain Plan and Schedule for correction","Select","IA77","2022-07-31",{"$f":"PartA!B369","v":"Select…"}]
["34e","VA ACUP - Significant Defeciencies Corrected","Select","IA37","2022-07-31",{"$f":"PartA!B372","v":"Select…"}]
["34e_detail","VA ACUP - Significant Defeciencies Corrected Detail","Select","IA38","2022-07-31",{"$f":"IF(PartA!C376=\"\",\"\",PartA!C376)","v":""}]
["35","Veterinary Medical Services","Select","IA67","2022-07-31",{"$f":"PartA!C378","v":"Select…"}]
["35a","PT Vet Service Arrangements","Select","IA68","2022-07-31",{"$f":"PartA!B379","v":"Select…"}]
["35a_detail","PT Vet Service Arrangements Details","Select","IA69","2022-07-31",{"$f":"IF(PartA!C383=\"\",\"\",PartA!C383)","v":""}]
["36","Affiliate ACUP Review and Facility Inspection","Select","IA66","2022-07-31",{"$f":"PartA!C388","v":"Select…"}]
["ACUPNotes","ACUP Section Notes","Select","IA50","2022-07-31",{"$f":"IF(PartA!C392=\"\",\"\",PartA!C392)","v":""}]
["37","RSSP","Select","RS1","2022-07-31",{"$f":"PartA!B395","v":"Select…"}]
["37a","SRS Waiver","Select","RS56","2022-07-31",{"$f":"PartA!B397","v":"Select…"}]
["38","Internal (Local) SRS","Select","RS5","2022-07-31",{"$f":"PartA!B400","v":"Select…"}]
["38a","SRS Chair","Select","RS62","2022-07-31",{"$f":"PartA!B404","v":"Select…"}]
["38b","Voting Members on SRS","Select","RS63","2022-07-31",{"$f":"PartA!B406","v":"Select…"}]
["38c","Safety and Radiation Safety Members on SRS","Select","RS64","2022-07-31",{"$f":"PartA!B411","v":"Select…"}]
["38d","IACUC Liaison to SRS","Select","RS65","2022-07-31",{"$f":"PartA!B414","v":"Select…"}]
["38e","Required SRS Ex-Officio Members","Select","RS66","2022-07-31",{"$f":"PartA!B416","v":"Select…"}]
["39","External (Another VAMC) SRS","Select","RS8","2022-07-31",{"$f":"PartA!B419","v":"Select…"}]
["39_detail","External SRS name","Select","RS9","2022-07-31",{"$f":"IF(PartA!C422=\"\",\"\",PartA!C422)","v":""}]
["39a","External SRS MOU","Select","RS13","2022-07-31",{"$f":"PartA!B423","v":"Select…"}]
["40","rDNA Research","Select","RS18","2022-07-31",{"$f":"PartA!B425","v":"Select…"}]
["40a","Internal (Local) IBC","Select","RS19","2022-07-31",{"$f":"PartA!B429","v":"Select…"}]
["40b","Internal IBC Separate from SRS","Select","RS50","2022-07-31",{"$f":"PartA!C433","v":"Select…"}]
["40c","Internal IBC Registered with NIH-OSP","Select","RS51","2022-07-31",{"$f":"PartA!B434","v":"Select…"}]
["40c_detail","Date of IBC Registration","Select","RS60","2022-07-31",{"$f":"IF(PartA!C437=\"\",\"\",PartA!C437)","v":""}]
["40d","External (Affiliate) IBC","Select","RS20","2022-07-31",{"$f":"PartA!B438","v":"Select…"}]
["40d_detail","External (Affiliate) name","Select","RS21","2022-07-31",{"$f":"IF(PartA!C441=\"\",\"\",PartA!C441)","v":""}]
["40e","External (Affiliate) IBC Registered with NIH-OSP","Select","RS23","2022-07-31",{"$f":"PartA!B442","v":"Select…"}]
["40e_detail","Date of External (Affiliate) IBC Registration","Select","RS67","2022-07-31",{"$f":"IF(PartA!C446=\"\",\"\",PartA!C446)","v":""}]
["40f","External (Affiliate) IBC MOU","Select","RS22","2022-07-31",{"$f":"PartA!B447","v":"Select…"}]
["41","Laboratory Research","Select","RS24","2022-07-31",{"$f":"PartA!B449","v":"Select…"}]
["41_detail_#VALabs","Number of VA Labs","Select","RS69","2022-07-31",{"$f":"PartA!B452","v":"Select…"}]
["41_detail_VALab","VA Lab Locations","Select","RS68","2022-07-31",{"$f":"IF(PartA!C454=\"\",\"\",PartA!C454)","v":""}]
["41_detail_#VALeasedLabs","Number of Off-Site VA-Leased Labs","Select","RS70","2022-07-31",{"$f":"PartA!B456","v":"Select…"}]
["41_detail_OffsiteVALeasedLab","Offsite VA Leased Lab Location","Select","RS57","2022-07-31",{"$f":"IF(PartA!C458=\"\",\"\",PartA!C458)","v":""}]
["41_detail_#NonVALabs","Number of Off-Site Non-VA Labs","Select","RS71","2022-07-31",{"$f":"PartA!B460","v":"Select…"}]
["41_detail_OffsiteNonVALab","Offsite Non-VA Lab Location","Select","RS26","2022-07-31",{"$f":"IF(PartA!C462=\"\",\"\",PartA!C462)","v":""}]
["41a","Offsite Waivers","Select","RS27","2022-07-31",{"$f":"PartA!B463","v":"Select…"}]
["41b","Review of Offsite Laboratories","Select","RS58","2022-07-31",{"$f":"PartA!B466","v":"Select…"}]
["42","BSL-3","Select","RS28","2022-07-31",{"$f":"PartA!B471","v":"Select…"}]
["42_detail","BSL-3 Infectious Agents","Select","RS55","2022-07-31",{"$f":"IF(PartA!C474=\"\",\"\",PartA!C474)","v":""}]
["42a","VA BSL-3","Select","RS30","2022-07-31",{"$f":"PartA!B475","v":"Select…"}]
["42a_detail","VA BSL-3 Location","Select","RS59","2022-07-31",{"$f":"IF(PartA!C478=\"\",\"\",PartA!C478)","v":""}]
["42b","Offsite BSL-3","Select","RS31","2022-07-31",{"$f":"PartA!B479","v":"Select…"}]
["42b_detail","Offsite BSL-3 Location","Select","RS32","2022-07-31",{"$f":"IF(PartA!C482=\"\",\"\",PartA!C482)","v":""}]
["42c","BSL-3 Manual","Select","RS29","2022-07-31",{"$f":"PartA!B483","v":"Select…"}]
["42d","SARS-Co-V-2 Positive Sample Storage","Select","RS72","2022-07-31",{"$f":"PartA!B486","v":"Select…"}]
["43","Chemical Hazards","Select","RS34","2022-07-31",{"$f":"PartA!B488","v":"Select…"}]
["43a","Chemical Hygiene Plan","Select","RS36","2022-07-31",{"$f":"PartA!B491","v":"Select…"}]
["43b","Chemical Inventories","Select","RS37","2022-07-31",{"$f":"PartA!B494","v":"Select…"}]
["44","Select Agents/Toxins","Select","RS38","2022-07-31",{"$f":"PartA!B497","v":"Select…"}]
["44_detail","Select Agents/Toxins Detail","Select","RS39","2022-07-31",{"$f":"IF(PartA!C500=\"\",\"\",PartA!C500)","v":""}]
["45a","Research Safety Plan","Select","RS42","2022-07-31",{"$f":"PartA!B503","v":"Select…"}]
["45b","Research Security Plan","Select","RS43","2022-07-31",{"$f":"PartA!B505","v":"Select…"}]
["45c","Emergency Management Plan","Select","RS44","2022-07-31",{"$f":"PartA!B507","v":"Select…"}]
["45d","Bloodborne Pathogen Plan","Select","RS48","2022-07-31",{"$f":"PartA!B509","v":"Select…"}]
["45e","Bloodborne Pathogen Training","Select","RS73","2022-07-31",{"$f":"PartA!B511","v":"Select…"}]
["45f","Activate, Decommission, Transfer Labs",{"$f":"C195","v":"Select"},"RS74","2022-07-31",{"$f":"PartA!B516","v":"Select…"}]
["45g","SRS Annual Review of PI Lab Program","Select","RS75","2022-07-31",{"$f":"PartA!B518","v":"Select…"}]
["45h","Annual Lab Safety Inspections","Select","RS45","2022-07-31",{"$f":"PartA!B520","v":"Select…"}]
["45i","Annual Drills","Select","RS46","2022-07-31",{"$f":"PartA!B522","v":"Select…"}]
["45j","Eyewash Stations/Emergency Showers","Select","RS76","2022-07-31",{"$f":"PartA!B525","v":"Select…"}]
["45k","Occupational Health & Safety Plan","Select","RS53","2022-07-31",{"$f":"PartA!B528","v":"Select…"}]
["45l","PPE Hazard Assessments","Select","RS61","2022-07-31",{"$f":"PartA!B532","v":"Select…"}]
["45m","Laboratory Access","Select","RS54","2022-07-31",{"$f":"PartA!B535","v":"Select…"}]
["RSSPNotes","RSSP Section Notes","Select","RS49","2022-07-31",{"$f":"IF(PartA!C539=\"\",\"\",PartA!C539)","v":""}]
["46","System Interconnections","Select","IS1","2022-07-31",{"$f":"PartA!B542","v":"Select…"}]
["47","Air-Gapped Networks","Select","IS3","2022-07-31",{"$f":"PartA!B545","v":"Select…"}]
["47a","VA Information on Non-VA Network","Select","IS21","2022-07-31",{"$f":"PartA!B548","v":"Select…"}]
["47b","VASI on Non-VA Systems","Select","IS20","2022-07-31",{"$f":"PartA!B551","v":"Select…"}]
["48","VASI Transported Offsite/Outside VA","Select","IS6","2022-07-31",{"$f":"PartA!B554","v":"Select…"}]
["49","Non-VA External Info Systems (IT Equipment)","Select","IS8","2022-07-31",{"$f":"PartA!B556","v":"Select…"}]
["50","Use of VA Mobile and Portable Devices","Select","IS10","2022-07-31",{"$f":"PartA!B558","v":"Select…"}]
["51","Use of Non-VA Mobile or Portable Devices","Select","IS14","2022-07-31",{"$f":"PartA!B561","v":"Select…"}]
["52","Access Controls","Select","IS22","2022-07-31",{"$f":"PartA!B563","v":"Select…"}]
["53","Plan of Action and Milestones","Select","IS23","2022-07-31",{"$f":"PartA!B566","v":"Select…"}]
["RISPNotes","RISP Section Notes","Select","IS17","2022-07-31",{"$f":"IF(PartA!C570=\"\",\"\",PartA!C570)","v":""}]
["54","RIO Appointed","Select","RM1","2022-07-31",{"$f":"PartA!B573","v":"Select…"}]
["54a","RIO Contact Info","Select","RM2","2022-07-31",{"$f":"PartA!B577","v":"Select…"}]
["55","Misconduct Allegations","Select","RM4","2022-07-31",{"$f":"PartA!B580","v":"Select…"}]
["RMNotes","Research Misconduct Section Notes","Select","RM5","2022-07-31",{"$f":"IF(PartA!C584=\"\",\"\",PartA!C584)","v":""}]

{"sheet":"ExportB","index":5,"n_rows":169,"n_cols":8,"rows_kept":169,"cut":false,"hidden":true,"merged":[]}
["Question#","QuestionText","id-facility","id-question","ROC_QuestionKey","FDCdate","FDCresult","FDCcomment"]
["1","Total number of protocols followed by the R&DC only",{"$f":"LEFT(PartA!C2,FIND(\" \",PartA!C2,1)-1)","v":"Select"},1,"R1","2022-07-31",{"$f":"IF(PartB!C11=\"\",\"\",PartB!C11)","v":""}]
["1a","Protocols initiated prior to R&DC approval",{"$f":"C2","v":"Select"},2,"R2","2022-07-31",{"$f":"IF(PartB!C14=\"\",\"\",PartB!C14)","v":""}]
["1aDetails","DETAILS Protocols initiated prior to R&DC approval",{"$f":"C3","v":"Select"},147,"R5","2022-07-31",null,{"$f":"IF(PartB!B17=\"\",\"\",PartB!B17)","v":""}]
["2","Active human protocols","Select",5,"H1","2022-07-31",{"$f":"IF(PartB!C22=\"\",\"\",PartB!C22)","v":""}]
["MVP","DETAILS MVP active at site","Select",155,"H82","2022-07-31",null,false]
["AllOfUs","DETAILS All of Us active at site","Select",187,"H123","2022-07-31",null,false]
["3a","IRB-exempt human subjects protocols","Select",6,"H2","2022-07-31",{"$f":"IF(PartB!C28=\"\",\"\",PartB!C28)","v":""}]
["3b","Non-exempt human subjects protocols","Select",7,"H3","2022-07-31",{"$f":"IF(PartB!C29=\"\",\"\",PartB!C29)","v":""}]
["4","Greater than minimal risk protocols","Select",129,"H72","2022-07-31",{"$f":"IF(PartB!C31=\"\",\"\",PartB!C31)","v":""}]
["5a","Protocols with waivers of informed consent per 38CFR16.116","Select",9,"H5","2022-07-31",{"$f":"IF(PartB!C33=\"\",\"\",PartB!C33)","v":""}]
["5b","Protocols with waiver of documentation of informed consent per 38CFR16.117(c)","Select",8,"H4","2022-07-31",{"$f":"IF(PartB!C35=\"\",\"\",PartB!C35)","v":""}]
["6a","Protocols subject to 2018 Common Rule","Select",249,"H146","2022-07-31",{"$f":"IF(PartB!C39=\"\",\"\",PartB!C39)","v":""}]
["6b","Protocols subject to Pre-2018 Common Rule","Select",250,"H147","2022-07-31",{"$f":"IF(PartB!C40=\"\",\"\",PartB!C40)","v":""}]
["7","Protocols suspended/terminated early by IRB","Select",212,"H124","2022-07-31",{"$f":"IF(PartB!C42=\"\",\"\",PartB!C42)","v":""}]
["7Details","DETAILS Protocols suspended or terminated (Human)","Select",150,"H78","2022-07-31",null,{"$f":"IF(PartB!B50=\"\",\"\",PartB!B50)","v":""}]
["8","Number of serious or continuing noncompliance events (Human)","Select",110,"H64","2022-07-31",{"$f":"IF(PartB!C51=\"\",\"\",PartB!C51)","v":""}]
["8Details","DETAILS Serious/continuing noncompliance events (Human)","Select",151,"H79","2022-07-31",null,{"$f":"IF(PartB!B59=\"\",\"\",PartB!B59)","v":""}]
["9","Total number of human protocols receiving an IC audit","Select",12,"H8","2022-07-31",{"$f":"IF(PartB!C67=\"\",\"\",PartB!C67)","v":""}]
["10Calculated","Protocols not receiving IC audit","Select",251,"H148","2022-07-31",{"$f":"IF(PartB!C68=\"\",\"\",PartB!C68)","v":0}]
["10a","Protocols that should have received IC audit AND did not","Select",252,"H149","2022-07-31",{"$f":"IF(PartB!C70=\"\",\"\",PartB!C70)","v":""}]
["10aDetails","DETAILS Protocols that should have received IC audit AND did not","Select",253,"H150","2022-07-31",null,{"$f":"IF(PartB!B74=\"\",\"\",PartB!B74)","v":""}]
["11","Protocols requiring IRB continuing review (IC audit)","Select",13,"H9","2022-07-31",{"$f":"IF(PartB!C75=\"\",\"\",PartB!C75)","v":""}]
["11a","Protocols with lapse in continuing review (IC audit)","Select",14,"H10","2022-07-31",{"$f":"IF(PartB!C77=\"\",\"\",PartB!C77)","v":""}]
["11b","Protocols with activity during lapse (IC audit)","Select",15,"H11","2022-07-31",{"$f":"IF(PartB!C78=\"\",\"\",PartB!C78)","v":""}]
["11bDetails","DETAILS Protocols with activity during lapse (IC audit)","Select",154,"H81","2022-07-31",null,{"$f":"IF(PartB!B83=\"\",\"\",PartB!B83)","v":""}]
["12","Total number of ICDs audited","Select",16,"H12","2022-07-31",{"$f":"IF(PartB!C84=\"\",\"\",PartB!C84)","v":""}]
["12a","ICDs with zero deficiency","Select",17,"H13","2022-07-31",{"$f":"IF(PartB!C87=\"\",\"\",PartB!C87)","v":""}]
["12b","Missing informed consent documents","Select",18,"H14","2022-07-31",{"$f":"IF(PartB!C91=\"\",\"\",PartB!C91)","v":""}]
["12bDetails","DETAILS Missing informed consent documents","Select",156,"H83","2022-07-31",null,{"$f":"IF(PartB!B96=\"\",\"\",PartB!B96)","v":""}]
["12c","Incorrect version of ICD used","Select",188,"H121","2022-07-31",{"$f":"IF(PartB!C97=\"\",\"\",PartB!C97)","v":""}]
["12d","Incorrect ICDs used (from another study)","Select",116,"H67","2022-07-31",{"$f":"IF(PartB!C99=\"\",\"\",PartB!C99)","v":""}]
["12e","Incorrect ICDs used (unapproved)","Select",117,"H68","2022-07-31",{"$f":"IF(PartB!C101=\"\",\"\",PartB!C101)","v":""}]
["12eDetails","DETAILS ICDs unapproved or ICD from another study used","Select",216,"H128","2022-07-31",null,{"$f":"IF(PartB!B105=\"\",\"\",PartB!B105)","v":""}]
["12f","ICDs without subject signature","Select",20,"H16","2022-07-31",{"$f":"IF(PartB!C106=\"\",\"\",PartB!C106)","v":""}]
["12fDetails","DETAILS ICDs without subject signature","Select",157,"H84","2022-07-31",null,{"$f":"IF(PartB!B110=\"\",\"\",PartB!B110)","v":""}]
["12g","ICDs without subject date","Select",21,"H17","2022-07-31",{"$f":"IF(PartB!C111=\"\",\"\",PartB!C111)","v":""}]
["13","ICDs subject to 2018 CR","Select",190,"H101","2022-07-31",{"$f":"IF(PartB!C113=\"\",\"\",PartB!C113)","v":""}]
["13a","ICDs without key information up front","Select",191,"H102","2022-07-31",{"$f":"IF(PartB!C114=\"\",\"\",PartB!C114)","v":""}]
["13b","ICDs with identifiable info/biospecimens collected","Select",192,"H103","2022-07-31",{"$f":"IF(PartB!C116=\"\",\"\",PartB!C116)","v":""}]
["13c","ICDs without information/biospecimen statement on future use","Select",193,"H104","2022-07-31",{"$f":"IF(PartB!C118=\"\",\"\",PartB!C118)","v":""}]
["13d","ICDs requiring broad consent","Select",194,"H105","2022-07-31",{"$f":"IF(PartB!C121=\"\",\"\",PartB!C121)","v":""}]
["13e","ICDs with broad consent not signed","Select",195,"H106","2022-07-31",{"$f":"IF(PartB!C123=\"\",\"\",PartB!C123)","v":""}]
["13eDetails","DETAILS Broad consent not obtained","Select",217,"H129","2022-07-31",null,{"$f":"IF(PartB!B126=\"\",\"\",PartB!B126)","v":""}]
["14","Number of HIPAA authorizations required","Select",26,"H22","2022-07-31",{"$f":"IF(PartB!C127=\"\",\"\",PartB!C127)","v":""}]
["14a","Valid HIPAA authorizations not obtained","Select",27,"H23","2022-07-31",{"$f":"IF(PartB!C128=\"\",\"\",PartB!C128)","v":""}]
["14aDetails","DETAILS HIPAA authorizations not obtained or missing subject signature","Select",159,"H86","2022-07-31",null,{"$f":"IF(PartB!B133=\"\",\"\",PartB!B133)","v":""}]
["14b","HIPAA template VA-Form 10-0493 required","Select",132,"H75","2022-07-31",{"$f":"IF(PartB!C134=\"\",\"\",PartB!C134)","v":""}]
["14c","HIPAA template VA-Form 10-0493 not used","Select",133,"H76","2022-07-31",{"$f":"IF(PartB!C140=\"\",\"\",PartB!C140)","v":""}]
["15","Number of Veterans enrolled in MVP","Select",197,"H108","2022-07-31",{"$f":"IF(PartB!C142=\"\",\"\",PartB!C142)","v":""}]
["15a","MVP ICDs and HIPAA authorization audited","Select",198,"H109","2022-07-31",{"$f":"IF(PartB!C144=\"\",\"\",PartB!C144)","v":""}]
["ICDSectionNotes","DETAILS ICD Section Notes","Select",160,"H98","2022-07-31",null,{"$f":"IF(PartB!B150=\"\",\"\",PartB!B150)","v":""}]
["16","Total number of human protocols receiving a regulatory audit","Select",33,"H29","2022-07-31",{"$f":"IF(PartB!C155=\"\",\"\",PartB!C155)","v":""}]
["16a","Protocols audited greater than minimal risk","Select",203,"H114","2022-07-31",{"$f":"IF(PartB!C156=\"\",\"\",PartB!C156)","v":""}]
["16b","Min risk protocols approved by expedited review","Select",204,"H115","2022-07-31",{"$f":"IF(PartB!C157=\"\",\"\",PartB!C157)","v":""}]
["16bDetails","DETAILS GMR receiving expedited review","Select",218,"H130","2022-07-31",null,{"$f":"IF(PartB!B161=\"\",\"\",PartB!B161)","v":""}]
["17a","Protocols intiated without IRB approval","Select",38,"H34","2022-07-31",{"$f":"IF(PartB!C162=\"\",\"\",PartB!C162)","v":""}]
["17b","Protocols completed without IRB approval","Select",39,"H35","2022-07-31",{"$f":"IF(PartB!C163=\"\",\"\",PartB!C163)","v":""}]
["17c","Protocols intiated without R&DC approval (Human)","Select",40,"H36","2022-07-31",{"$f":"IF(PartB!C164=\"\",\"\",PartB!C164)","v":""}]
["17d","Protocols completed without R&DC Approval (Human)","Select",41,"H37","2022-07-31",{"$f":"IF(PartB!C165=\"\",\"\",PartB!C165)","v":""}]
["17e","Protocols initiated prior to ACOS/R letter","Select",254,"H151","2022-07-31",{"$f":"IF(PartB!C166=\"\",\"\",PartB!C166)","v":""}]
["17eDetails","DETAILS Protocols without approval","Select",182,"H99","2022-07-31",null,{"$f":"IF(PartB!B169=\"\",\"\",PartB!B169)","v":""}]
["18","Number of international research protocols","Select",60,"H56","2022-07-31",{"$f":"IF(PartB!C170=\"\",\"\",PartB!C170)","v":""}]
["18a","International protocols without FD/CRADO approval","Select",61,"H57","2022-07-31",{"$f":"IF(PartB!C171=\"\",\"\",PartB!C171)","v":""}]
["18aDetails","DETAILS No approval for international protocol","Select",178,"H93","2022-07-31",null,{"$f":"IF(PartB!B175=\"\",\"\",PartB!B175)","v":""}]
["19","Number of protocols involving children","Select",62,"H58","2022-07-31",{"$f":"IF(PartB!C176=\"\",\"\",PartB!C176)","v":""}]
["19a","Protocols involving children without FD/CRADO approval","Select",63,"H59","2022-07-31",{"$f":"IF(PartB!C177=\"\",\"\",PartB!C177)","v":""}]
["19aDetails","DETAILS No approval for protocol with children",{"$f":"C67","v":"Select"},179,"H94","2022-07-31",null,{"$f":"IF(PartB!B181=\"\",\"\",PartB!B181)","v":""}]
["20","Number of protocols involving prisoners","Select",64,"H60","2022-07-31",{"$f":"IF(PartB!C182=\"\",\"\",PartB!C182)","v":""}]
["20a","Protocols without CRADO approval","Select",65,"H61","2022-07-31",{"$f":"IF(PartB!C183=\"\",\"\",PartB!C183)","v":""}]
["20aDetails","DETAILS no approval for protocol with prisoners","Select",180,"H95","2022-07-31",null,{"$f":"IF(PartB!B186=\"\",\"\",PartB!B186)","v":""}]
["21","Protocols audited subject to 2018 Common Rule","Select",202,"H113","2022-07-31",{"$f":"IF(PartB!C187=\"\",\"\",PartB!C187)","v":""}]
["21a","Protocols audited that were IRB-exempt","Select",205,"H116","2022-07-31",{"$f":"IF(PartB!C188=\"\",\"\",PartB!C188)","v":""}]
["21b","Exempt category not documented","Select",206,"H117","2022-07-31",{"$f":"IF(PartB!C189=\"\",\"\",PartB!C189)","v":""}]
["21c","Exempt category does not match regulatory description","Select",207,"H118","2022-07-31",{"$f":"IF(PartB!C191=\"\",\"\",PartB!C191)","v":""}]
["21cDetails","DETAILS Incorrect exempt category","Select",219,"H131","2022-07-31",null,{"$f":"IF(PartB!B196=\"\",\"\",PartB!B196)","v":""}]
["21d","IRB-exempt protocols requiring limited IRB review","Select",208,"H119","2022-07-31",{"$f":"IF(PartB!C197=\"\",\"\",PartB!C197)","v":""}]
["21e","Protocols not receiving required limited IRB review","Select",209,"H120","2022-07-31",{"$f":"IF(PartB!C199=\"\",\"\",PartB!C199)","v":""}]
["21eDetails","DETAILS No limited IRB review","Select",220,"H132","2022-07-31",null,{"$f":"IF(PartB!B203=\"\",\"\",PartB!B203)","v":""}]
["21f","Exempt protocols without required information provided to subjects","Select",221,"H133","2022-07-31",{"$f":"IF(PartB!C204=\"\",\"\",PartB!C204)","v":""}]
["21fDetails","DETAILS Exempt protocols without required information provided to subjects","Select",222,"H134","2022-07-31",null,{"$f":"IF(PartB!B209=\"\",\"\",PartB!B209)","v":""}]
["22","Protocols requiring IRB continuing review (HRPP audit)","Select",45,"H41","2022-07-31",{"$f":"IF(PartB!C210=\"\",\"\",PartB!C210)","v":""}]
["23","Protocols with CR required by IRB (not required by 1200.05)","Select",223,"H135","2022-07-31",{"$f":"IF(PartB!C211=\"\",\"\",PartB!C211)","v":""}]
["24a","Protocols with lapse in IRB continuing review (HRPP audit)","Select",46,"H42","2022-07-31",{"$f":"IF(PartB!C213=\"\",\"\",PartB!C213)","v":""}]
["24b","Protocols with activity during lapse (HRPP audit)","Select",47,"H43","2022-07-31",{"$f":"IF(PartB!C216=\"\",\"\",PartB!C216)","v":""}]
["24bDetails","DETAILS Protocols with activity during lapse (HRPP audit)","Select",175,"H90","2022-07-31",null,{"$f":"IF(PartB!B221=\"\",\"\",PartB!B221)","v":""}]
["24c","Protocols with rationale for IRB-required CR documented","Select",224,"H136","2022-07-31",{"$f":"IF(PartB!C222=\"\",\"\",PartB!C222)","v":""}]
["24cDetails","DETAILS No continuing review documentation","Select",239,"H141","2022-07-31",null,{"$f":"IF(PartB!B224=\"\",\"\",PartB!B224)","v":""}]
["25","Protocols subject to single IRB requirement","Select",225,"H137","2022-07-31",{"$f":"IF(PartB!C225=\"\",\"\",PartB!C225)","v":""}]
["25a","Single IRB protocols","Select",255,"H152","2022-07-31",{"$f":"IF(PartB!C226=\"\",\"\",PartB!C226)","v":""}]
["25b","Single IRB protocols without valid reliance agreement","Select",256,"H153","2022-07-31",{"$f":"IF(PartB!C227=\"\",\"\",PartB!C227)","v":""}]
["25c","Single IRB protocols NOT reviewed by single IRB","Select",257,"H154","2022-07-31",{"$f":"IF(PartB!C229=\"\",\"\",PartB!C229)","v":""}]
["25d","Single IRB protocols without valid exception","Select",258,"H155","2022-07-31",{"$f":"IF(PartB!C230=\"\",\"\",PartB!C230)","v":""}]
["25dDetails","DETAILS No reliance agreement or exception","Select",240,"H142","2022-07-31",null,{"$f":"IF(PartB!B234=\"\",\"\",PartB!B234)","v":""}]
["26","Local adverse events and apparent UPIRTSOs","Select",259,"H156","2022-07-31",{"$f":"IF(PartB!C235=\"\",\"\",PartB!C235)","v":""}]
["26a","Local AEs determined to be serious, unanticipated and related","Select",42,"H38","2022-07-31",{"$f":"IF(PartB!C238=\"\",\"\",PartB!C238)","v":""}]
["26b","SAEs not reported to IRB in a timely manner","Select",119,"H70","2022-07-31",{"$f":"IF(PartB!C240=\"\",\"\",PartB!C240)","v":""}]
["26c","SAEs not reviewed and categorized by the IRB in a timely manner","Select",120,"H71","2022-07-31",{"$f":"IF(PartB!C242=\"\",\"\",PartB!C242)","v":""}]
["26cDetails","DETAILS SAEs not reported or reviewed within required timeframe","Select",227,"H139","2022-07-31",null,{"$f":"IF(PartB!B246=\"\",\"\",PartB!B246)","v":""}]
["27","Total number of research personnel in human protocols audited","Select",55,"H51","2022-07-31",{"$f":"IF(PartB!C247=\"\",\"\",PartB!C247)","v":""}]
["27a","Personnel with lapse in required training (Human)","Select",58,"H54","2022-07-31",{"$f":"IF(PartB!C249=\"\",\"\",PartB!C249)","v":""}]
["27b","Personnel without initial training (Human)","Select",59,"H55","2022-07-31",{"$f":"IF(PartB!C252=\"\",\"\",PartB!C252)","v":""}]
["27bDetails","DETAILS No initial human subjects training","Select",228,"H140","2022-07-31",null,{"$f":"IF(PartB!B256=\"\",\"\",PartB!B256)","v":""}]
["28","Total number of subject records reviewed","Select",48,"H44","2022-07-31",{"$f":"IF(PartB!C257=\"\",\"\",PartB!C257)","v":""}]
["28a","Number of records without documentation of IC prior to research","Select",49,"H45","2022-07-31",{"$f":"IF(PartB!C260=\"\",\"\",PartB!C260)","v":""}]
["28aDetails","DETAILS Research prior to IC","Select",176,"H91","2022-07-31",null,{"$f":"IF(PartB!B265=\"\",\"\",PartB!B265)","v":""}]
["28b","Number of records with Inclusion/Exclusion criteria","Select",50,"H46","2022-07-31",{"$f":"IF(PartB!C266=\"\",\"\",PartB!C266)","v":""}]
["28c","Number of subjects included in research not meeting incl/excl","Select",54,"H50","2022-07-31",{"$f":"IF(PartB!C270=\"\",\"\",PartB!C270)","v":""}]
["28cDetails","DETAILS Subjects included not meeting Incl/Excl criteria","Select",177,"H92","2022-07-31",null,{"$f":"IF(PartB!B276=\"\",\"\",PartB!B276)","v":""}]
["HRPPNotes","DETAILS HRPP/IRB section notes","Select",184,"H97","2022-07-31",null,{"$f":"IF(PartB!B278=\"\",\"\",PartB!B278)","v":""}]
["29","Active animal protocols","Select",66,"A1","2022-07-31",{"$f":"IF(PartB!C286=\"\",\"\",PartB!C286)","v":""}]
["30","Protocols suspended/terminated early by IACUC","Select",229,"A42","2022-07-31",{"$f":"IF(PartB!C287=\"\",\"\",PartB!C287)","v":""}]
["30Details","DETAILS Suspensions or terminations","Select",173,"A38","2022-07-31",null,{"$f":"IF(PartB!B293=\"\",\"\",PartB!B293)","v":""}]
["31","Number of serious or continuing noncompliance events (Animal)","Select",243,"A46","2022-07-31",{"$f":"IF(PartB!C294=\"\",\"\",PartB!C294)","v":""}]
["31Details","DETAILS serious/continuing noncompliance events (Animal)","Select",244,"A47","2022-07-31",null,{"$f":"IF(PartB!B300=\"\",\"\",PartB!B300)","v":""}]
["32","Total number of animal research protocols audited","Select",72,"A7","2022-07-31",{"$f":"IF(PartB!C303=\"\",\"\",PartB!C303)","v":""}]
["33","Protocols with controlled substances (Animal)","Select",122,"A31","2022-07-31",{"$f":"IF(PartB!C305=\"\",\"\",PartB!C305)","v":""}]
["33a","Protocols  with controlled substances conducted at the VA","Select",135,"A34","2022-07-31",{"$f":"IF(PartB!C306=\"\",\"\",PartB!C306)","v":""}]
["33b","Protocols with CS not obtained through VA pharmacy","Select",136,"A35","2022-07-31",{"$f":"IF(PartB!C307=\"\",\"\",PartB!C307)","v":""}]
["33bDetails","DETAILS CS not obtained through VA pharmacy","Select",230,"A43","2022-07-31",null,{"$f":"IF(PartB!B312=\"\",\"\",PartB!B312)","v":""}]
["33c","Controlled substance not properly stored","Select",210,"A41","2022-07-31",{"$f":"IF(PartB!C313=\"\",\"\",PartB!C313)","v":""}]
["33cDetails","DETAILS CS not properly stored","Select",231,"A44","2022-07-31",null,{"$f":"IF(PartB!B318=\"\",\"\",PartB!B318)","v":""}]
["34a","Protocols initiated prior to IACUC approval","Select",78,"A13","2022-07-31",{"$f":"IF(PartB!C321=\"\",\"\",PartB!C321)","v":""}]
["34b","Protocols completed without IACUC approval","Select",79,"A14","2022-07-31",{"$f":"IF(PartB!C322=\"\",\"\",PartB!C322)","v":""}]
["34c","Protocols initated prior to R&DC approval (Animal)","Select",80,"A15","2022-07-31",{"$f":"IF(PartB!C323=\"\",\"\",PartB!C323)","v":""}]
["34d","Protocols completed without R&DC approval (Animal)","Select",81,"A16","2022-07-31",{"$f":"IF(PartB!C324=\"\",\"\",PartB!C324)","v":""}]
["34e","Protocols initiated prior to ACOS/R letter (animal)","Select",260,"A49","2022-07-31",{"$f":"IF(PartB!C325=\"\",\"\",PartB!C325)","v":""}]
["34eDetails","DETAILS research initiated prior to approval","Select",183,"A39","2022-07-31",null,{"$f":"IF(PartB!B329=\"\",\"\",PartB!B329)","v":""}]
["35","Protocols requiring IACUC annual review","Select",123,"A32","2022-07-31",{"$f":"IF(PartB!C330=\"\",\"\",PartB!C330)","v":""}]
["35a","Protocols with lapse in IACUC annual review","Select",113,"A27","2022-07-31",{"$f":"IF(PartB!C331=\"\",\"\",PartB!C331)","v":""}]
["35b","Protocols requiring IACUC triennial review","Select",124,"A33","2022-07-31",{"$f":"IF(PartB!C332=\"\",\"\",PartB!C332)","v":""}]
["35c","Protocols with lapse in IACUC triennial review",{"$f":"C131","v":"Select"},114,"A28","2022-07-31",{"$f":"IF(PartB!C333=\"\",\"\",PartB!C333)","v":""}]
["35d","Protocols with activity during  triennial review lapse","Select",115,"A29","2022-07-31",{"$f":"IF(PartB!C334=\"\",\"\",PartB!C334)","v":""}]
["35dDetails","DETAILS Protocols with activity during triennial review lapse","Select",172,"A37","2022-07-31",null,{"$f":"IF(PartB!B339=\"\",\"\",PartB!B339)","v":""}]
["36","Total number of research personnel in animal protocols audited","Select",87,"A22","2022-07-31",{"$f":"IF(PartB!C340=\"\",\"\",PartB!C340)","v":""}]
["36a","Personnel with lapse in required training (Animal)","Select",90,"A25","2022-07-31",{"$f":"IF(PartB!C342=\"\",\"\",PartB!C342)","v":""}]
["36b","Personnel without initial training (Animal)","Select",91,"A26","2022-07-31",{"$f":"IF(PartB!C345=\"\",\"\",PartB!C345)","v":""}]
["36bDetails","DETAILS No initial animal welfare training","Select",232,"A45","2022-07-31",null,{"$f":"IF(PartB!B349=\"\",\"\",PartB!B349)","v":""}]
["ACUPSectionNotes","DETAILS ACUP/IACUC section notes","Select",171,"A36","2022-07-31",null,{"$f":"IF(PartB!B351=\"\",\"\",PartB!B351)","v":""}]
["37","Active safety protocols","Select",92,"S1","2022-07-31",{"$f":"IF(PartB!C359=\"\",\"\",PartB!C359)","v":""}]
["37a","Active basic science protocols","Select",137,"S21","2022-07-31",{"$f":"IF(PartB!C360=\"\",\"\",PartB!C360)","v":""}]
["38","Protocols suspended/terminated early by SRS","Select",233,"S38","2022-07-31",{"$f":"IF(PartB!C362=\"\",\"\",PartB!C362)","v":""}]
["38Details","DETAILS Suspensions or terminations","Select",170,"S35","2022-07-31",null,{"$f":"IF(PartB!B368=\"\",\"\",PartB!B368)","v":""}]
["39","Number of serious or continuing noncompliance events (Safety)","Select",245,"S44","2022-07-31",{"$f":"IF(PartB!C369=\"\",\"\",PartB!C369)","v":""}]
["39Details","DETAILS serious/continuing noncompliance events (Safety)","Select",246,"S45","2022-07-31",null,{"$f":"IF(PartB!B375=\"\",\"\",PartB!B375)","v":""}]
["40","Total number of safety protocols audited","Select",97,"S6","2022-07-31",{"$f":"IF(PartB!C378=\"\",\"\",PartB!C378)","v":""}]
["41","Protocols conducted completely or partially off-site","Select",125,"S17","2022-07-31",{"$f":"IF(PartB!C380=\"\",\"\",PartB!C380)","v":""}]
["41a","Protocols without required off-site waiver","Select",139,"S27","2022-07-31",{"$f":"IF(PartB!C381=\"\",\"\",PartB!C381)","v":""}]
["42","Protocols with chemical hazards","Select",127,"S19","2022-07-31",{"$f":"IF(PartB!C382=\"\",\"\",PartB!C382)","v":""}]
["42a","Protocols without required semi-annual chemical inventory review","Select",234,"S39","2022-07-31",{"$f":"IF(PartB!C383=\"\",\"\",PartB!C383)","v":""}]
["43","Protocols with radiation hazards","Select",128,"S20","2022-07-31",{"$f":"IF(PartB!C386=\"\",\"\",PartB!C386)","v":""}]
["43a","Protocol not reviewed by radiation/safety officer","Select",144,"S28","2022-07-31",{"$f":"IF(PartB!C387=\"\",\"\",PartB!C387)","v":""}]
["44a","Protocols initiated prior to SRS approval","Select",98,"S7","2022-07-31",{"$f":"IF(PartB!C391=\"\",\"\",PartB!C391)","v":""}]
["44b","Protocols completed without SRS approval","Select",99,"S8","2022-07-31",{"$f":"IF(PartB!C392=\"\",\"\",PartB!C392)","v":""}]
["44c","Protocols without written notification of SRS review","Select",235,"S40","2022-07-31",{"$f":"IF(PartB!C393=\"\",\"\",PartB!C393)","v":""}]
["44d","Protocols intiated prior to R&DC approval (Safety)","Select",103,"S12","2022-07-31",{"$f":"IF(PartB!C397=\"\",\"\",PartB!C397)","v":""}]
["44e","Protocols completed without R&DC approval (Safety)","Select",104,"S13","2022-07-31",{"$f":"IF(PartB!C398=\"\",\"\",PartB!C398)","v":""}]
["44f","Protocols initiated priot to ACOS/R letter (safety)","Select",261,"S46","2022-07-31",{"$f":"IF(PartB!C399=\"\",\"\",PartB!C399)","v":""}]
["44fDetails","DETAILS Protocols without SRS approval","Select",167,"S32","2022-07-31",null,{"$f":"IF(PartB!B403=\"\",\"\",PartB!B403)","v":""}]
["45","Protocols requiring IBC approval","Select",100,"S9","2022-07-31",{"$f":"IF(PartB!C404=\"\",\"\",PartB!C404)","v":""}]
["45a","Protocols initiated prior to IBC approval","Select",101,"S10","2022-07-31",{"$f":"IF(PartB!C406=\"\",\"\",PartB!C406)","v":""}]
["45b","Protocols completed without IBC approval","Select",102,"S11","2022-07-31",{"$f":"IF(PartB!C407=\"\",\"\",PartB!C407)","v":""}]
["45c","Protocols without written notification of IBC review","Select",236,"S41","2022-07-31",{"$f":"IF(PartB!C408=\"\",\"\",PartB!C408)","v":""}]
["45cDetails","DETAILS Protocols without IBC approval","Select",237,"S42","2022-07-31",null,{"$f":"IF(PartB!B414=\"\",\"\",PartB!B414)","v":""}]
["46","Total number of research personnel in safety protocols audited","Select",164,"S29","2022-07-31",{"$f":"IF(PartB!C415=\"\",\"\",PartB!C415)","v":""}]
["46a","Personnel with lapse in required training (Safety)","Select",165,"S30","2022-07-31",{"$f":"IF(PartB!C417=\"\",\"\",PartB!C417)","v":""}]
["46b","Personnel without initial training (Safety)","Select",166,"S31","2022-07-31",{"$f":"IF(PartB!C420=\"\",\"\",PartB!C420)","v":""}]
["46bDetails","DETAILS No initial safety training","Select",238,"S43","2022-07-31",null,{"$f":"IF(PartB!B424=\"\",\"\",PartB!B424)","v":""}]
["RSSSectionNotes","RSSP/SRS Section Notes","Select",186,"S36","2022-07-31",null,{"$f":"IF(PartB!B426=\"\",\"\",PartB!B426)","v":""}]

{"sheet":"Drop-down","index":6,"n_rows":111,"n_cols":24,"rows_kept":111,"cut":false,"hidden":true,"merged":[]}
["VISN","Facility #","Facility","Select Facility…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…"]
[1,402,"VA Maine Healthcare System - Togus","402 VA Maine Healthcare System - Togus",null,"Yes",null,"Yes",null,"Continued full accreditation",null,"Only at the VA animal facility",null,"Full-time",null,"A full-time VA employed veterinarian",null,"The VA IACUC performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC performs its own program review and facility inspection of the affiliate(s) animal program.",null,0,null,"The IBC is a separate committee from the SRS. "]
[1,405,"White River Junction VA Medical Center","405 White River Junction VA Medical Center",null,"No",null,"No",null,"Conditional accreditation",null,"Only at the affiliate animal facility",null,"Part-time",null,"A part-time VA employed veterinarian",null,"The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC accepts the semiannual reports of the affiliate IACUC (in lieu of performing its own facility inspection and program review) as a business item during a convened meeting.",null,"1--5",null,"The SRS is constituted as an IBC, and convenes as an IBC/SRS (a single set of minutes are produced)."]
[23,437,"Fargo VA Health Care System","437 Fargo VA Health Care System",null,"N/A",null,null,null,"Deferred accreditation",null,"Both at the VA and affiliate animal facility",null,null,null,"A full-time contracted veterinarian",null,null,null,null,null,"6--10",null,"The SRS is constituted as an IBC, but separate IBC and SRS meetings are convened (two sets of minutes are produced)."]
[23,438,"Sioux Falls VA Health Care System","438 Sioux Falls VA Health Care System",null,null,null,null,null,"Probation",null,null,null,null,null,"A part-time contracted veterinarian",null,null,null,null,null,"11--15"]
[21,459,"VA Pacific Islands Health Care System","459 VA Pacific Islands Health Care System",null,null,null,null,null,"Revoked accreditation",null,null,null,null,null,null,null,null,null,null,null,"16--20"]
[4,460,"Wilmington VA Medical Center","460 Wilmington VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"> 20"]
[22,501,"New Mexico VA Health Care System","501 New Mexico VA Health Care System"]
[10,506,"VA Ann Arbor Healthcare System","506 VA Ann Arbor Healthcare System"]
[7,508,"Atlanta VA Medical Center","508 Atlanta VA Medical Center"]
[7,509,"Charlie Norwood VA Medical Center","509 Charlie Norwood VA Medical Center"]
[5,512,"VA Maryland Health Care System","512 VA Maryland Health Care System"]
[10,515,"Battle Creek VA Medical Center","515 Battle Creek VA Medical Center"]
[8,516,"Bay Pines VA Healthcare System","516 Bay Pines VA Healthcare System"]
[1,518,"Edith Nourse Rogers Memorial VA Hospital","518 Edith Nourse Rogers Memorial VA Hospital"]
[16,520,"Gulf Coast Veterans Health Care System","520 Gulf Coast Veterans Health Care System"]
[7,521,"Birmingham VA Medical Center","521 Birmingham VA Medical Center"]
[1,523,"VA Boston Healthcare System","523 VA Boston Healthcare System"]
[2,526,"James J. Peters VA Medical Center","526 James J. Peters VA Medical Center"]
[2,528,"VA Western New York Healthcare System","528 VA Western New York Healthcare System"]
[2,"528A6","VA Finger Lakes Healthcare System","528A6 VA Finger Lakes Healthcare System"]
[2,"528A7","Syracuse VA Medical Center","528A7 Syracuse VA Medical Center"]
[2,"528A8","Albany VA Medical Center: Samuel S. Stratton","528A8 Albany VA Medical Center: Samuel S. Stratton"]
[20,531,"Boise VA Medical Center","531 Boise VA Medical Center"]
[7,534,"Ralph H. Johnson VA Medical Center","534 Ralph H. Johnson VA Medical Center"]
[12,537,"Jesse Brown VA Medical Center","537 Jesse Brown VA Medical Center"]
[10,538,"Chillicothe VA Medical Center","538 Chillicothe VA Medical Center"]
[10,539,"Cincinnati VA Medical Center","539 Cincinnati VA Medical Center"]
[5,540,"Louis A. Johnson VA Medical Center","540 Louis A. Johnson VA Medical Center"]
[10,541,"VA Northeast Ohio Healthcare System","541 VA Northeast Ohio Healthcare System"]
[4,542,"Coatesville VA Medical Center","542 Coatesville VA Medical Center"]
[7,544,"Wm. Jennings Bryan Dorn VA Medical Center","544 Wm. Jennings Bryan Dorn VA Medical Center"]
[8,546,"Miami VA Healthcare System","546 Miami VA Healthcare System"]
[8,548,"West Palm Beach VA Medical Center","548 West Palm Beach VA Medical Center"]
[17,549,"VA North Texas Health Care System","549 VA North Texas Health Care System"]
[10,552,"Dayton VA Medical Center","552 Dayton VA Medical Center"]
[10,553,"John D. Dingell VA Medical Center","553 John D. Dingell VA Medical Center"]
[19,554,"VA Eastern Colorado Health Care System","554 VA Eastern Colorado Health Care System"]
[12,556,"Captain James A. Lovell Federal Health Care Center","556 Captain James A. Lovell Federal Health Care Center"]
[6,558,"Durham VA Health Care System","558 Durham VA Health Care System"]
[2,561,"VA New Jersey Health Care System","561 VA New Jersey Health Care System"]
[16,564,"Veterans Health Care System of the Ozarks","564 Veterans Health Care System of the Ozarks"]
[21,570,"VA Central California Health Care System","570 VA Central California Health Care System"]
[8,573,"North Florida/South Georgia Veterans Health System","573 North Florida/South Georgia Veterans Health System"]
[12,578,"Edward Hines Jr. VA Hospital","578 Edward Hines Jr. VA Hospital"]
[16,580,"Michael E. DeBakey VA Medical Center","580 Michael E. DeBakey VA Medical Center"]
[5,581,"Hershel Woody Williams VA Medical Center","581 Hershel Woody Williams VA Medical Center"]
[10,583,"Richard L. Roudebush VA Medical Center","583 Richard L. Roudebush VA Medical Center"]
[16,586,"G.V. (Sonny) Montgomery VA Medical Center","586 G.V. (Sonny) Montgomery VA Medical Center"]
[15,589,"Kansas City VA Medical Center","589 Kansas City VA Medical Center"]
[15,"589A4","Harry S. Truman Memorial Veterans' Hospital","589A4 Harry S. Truman Memorial Veterans' Hospital"]
[15,"589A6","VA Eastern Kansas Health Care System","589A6 VA Eastern Kansas Health Care System"]
[15,"589A7","Robert J. Dole VA Medical Center","589A7 Robert J. Dole VA Medical Center"]
[6,590,"Hampton VA Medical Center","590 Hampton VA Medical Center"]
[21,593,"VA Southern Nevada Healthcare System","593 VA Southern Nevada Healthcare System"]
[9,596,"Lexington VA Healthcare System","596 Lexington VA Healthcare System"]
[16,598,"Central Arkansas Veterans Healthcare System","598 Central Arkansas Veterans Healthcare System"]
[22,600,"VA Long Beach Healthcare System","600 VA Long Beach Healthcare System"]
[9,603,"Robley Rex VA Medical Center","603 Robley Rex VA Medical Center"]
[22,605,"VA Loma Linda Healthcare System","605 VA Loma Linda Healthcare System"]
[12,607,"William S. Middleton Memorial Veterans Hospital","607 William S. Middleton Memorial Veterans Hospital"]
[1,608,"Manchester VA Medical Center","608 Manchester VA Medical Center"]
[21,612,"VA Northern California Health Care System","612 VA Northern California Health Care System"]
[5,613,"Martinsburg VA Medical Center","613 Martinsburg VA Medical Center"]
[9,614,"Memphis VA Medical Center","614 Memphis VA Medical Center"]
[23,618,"Minneapolis VA Health Care System","618 Minneapolis VA Health Care System"]
[2,620,"VA Hudson Valley Health Care System","620 VA Hudson Valley Health Care System"]
[9,621,"James H. Quillen VA Medical Center","621 James H. Quillen VA Medical Center"]
[19,623,"Eastern Oklahoma VA Health Care System","623 Eastern Oklahoma VA Health Care System"]
[9,626,"Tennessee Valley Healthcare System","626 Tennessee Valley Healthcare System"]
[16,629,"Southeast Louisiana Veterans Health Care System","629 Southeast Louisiana Veterans Health Care System"]
[2,630,"VA NY Harbor Healthcare System","630 VA NY Harbor Healthcare System"]
[1,631,"VA Central Western Massachusetts Healthcare System","631 VA Central Western Massachusetts Healthcare System"]
[2,632,"Northport VA Medical Center","632 Northport VA Medical Center"]
[19,635,"Oklahoma City VA Health Care System","635 Oklahoma City VA Health Care System"]
[23,636,"VA Nebraska-Western Iowa Health Care System","636 VA Nebraska-Western Iowa Health Care System"]
[23,"636A8","Iowa City VA Health Care System","636A8 Iowa City VA Health Care System"]
[6,637,"Charles George VA Medical Center","637 Charles George VA Medical Center"]
[21,640,"VA Palo Alto Health Care System","640 VA Palo Alto Health Care System"]
[4,642,"Corporal Michael J. Crescenz VA Medical Center","642 Corporal Michael J. Crescenz VA Medical Center"]
[22,644,"Phoenix VA Health Care System","644 Phoenix VA Health Care System"]
[4,646,"VA Pittsburgh Healthcare System","646 VA Pittsburgh Healthcare System"]
[20,648,"VA Portland Healthcare System","648 VA Portland Healthcare System"]
[22,649,"Northern Arizona VA Health Care System","649 Northern Arizona VA Health Care System"]
[1,650,"VA Providence Healthcare System","650 VA Providence Healthcare System"]
[6,652,"Central Virginia VA Health Care System","652 Central Virginia VA Health Care System"]
[21,654,"VA Sierra Nevada Health Care System","654 VA Sierra Nevada Health Care System"]
[10,655,"Aleda E. Lutz VA Medical Center","655 Aleda E. Lutz VA Medical Center"]
[23,656,"St. Cloud VA Health Care System","656 St. Cloud VA Health Care System"]
[15,657,"VA St. Louis Health Care System","657 VA St. Louis Health Care System"]
[6,658,"Salem VA Medical Center","658 Salem VA Medical Center"]
[6,659,"W.G. (Bill) Hefner VA Medical Center","659 W.G. (Bill) Hefner VA Medical Center"]
[19,660,"VA Salt Lake City Health Care System","660 VA Salt Lake City Health Care System"]
[21,662,"San Francisco VA Health Care System","662 San Francisco VA Health Care System"]
[20,663,"VA Puget Sound Health Care System","663 VA Puget Sound Health Care System"]
[22,664,"VA San Diego Healthcare System","664 VA San Diego Healthcare System"]
[16,667,"Overton Brooks VA Medical Center","667 Overton Brooks VA Medical Center"]
[20,668,"Mann-Grandstaff VA Medical Center","668 Mann-Grandstaff VA Medical Center"]
[17,671,"South Texas Veterans Health Care System","671 South Texas Veterans Health Care System"]
[8,672,"VA Caribbean Healthcare System","672 VA Caribbean Healthcare System"]
[8,673,"James A. Haley Veterans' Hospital","673 James A. Haley Veterans' Hospital"]
[17,674,"Central Texas Veterans Health Care System","674 Central Texas Veterans Health Care System"]
[8,675,"Orlando VA Medical Center","675 Orlando VA Medical Center"]
[22,678,"Southern Arizona VA Health Care System","678 Southern Arizona VA Health Care System"]
[7,679,"Tuscaloosa VA Medical Center","679 Tuscaloosa VA Medical Center"]
[5,688,"Washington DC VA Medical Center","688 Washington DC VA Medical Center"]
[1,689,"VA Connecticut Healthcare System","689 VA Connecticut Healthcare System"]
[22,691,"VA Greater Los Angeles Healthcare System","691 VA Greater Los Angeles Healthcare System"]
[4,693,"Wilkes-Barre VA Medical Center","693 Wilkes-Barre VA Medical Center"]
[12,695,"Clement J. Zablocki VA Medical Center","695 Clement J. Zablocki VA Medical Center"]
[10,757,"Chalmers P. Wylie VA Ambulatory Care Center","757 Chalmers P. Wylie VA Ambulatory Care Center"]