ࡱ> '*$%&W bjbjPP 2e2ey%a  aaaaaduL~n}m#^###$.&&\$.a($$((aa##0&-&-&-(Fa#a#&-(&-&-Jv\z# l6)OyBB<~yЈ)ЈzЈazX>'>|',&-'$'$>'>'>'~+>'>'>'~((((Ј>'>'>'>'>'>'>'>'>' ': Portland VA Medical Center Financial Administrative Review of Research Proposals The Financial Administrative Review is the method the PVAMC uses to assess the costs of the clinical resources and the Principal Investigators protected time that is committed to a research project. Please submit completed forms to  HYPERLINK "mailto:Research.Grants@va.gov" Research.Grants@va.gov. Investigator Name:  FORMTEXT       Project Title:  FORMTEXT       Funding Source:  FORMTEXT       Project Period:  FORMTEXT       SECTION I: PART A: Use of Research PharmacyYesNo1.0Will your study involve the use of the VA pharmacy? FORMCHECKBOX  FORMCHECKBOX If YES, you must submit your proposal and the investigational drug information record (VA Form 10-9012) to Eileen Wilbur, RPh (extension 54757) to determine the total cost to the Pharmacy Service on a per patient basis and enter this information here. Cost per patient:  FORMTEXT       **PLEASE attach the signed cost estimate worksheet from Pharmacy to this document** 1.1Does the funding source provide the drug under investigation at no cost to the PVAMC?   FORMCHECKBOX   FORMCHECKBOX PART B: Use of Pathology and Laboratory Services2.0Will your study involve the use of the VA Pathology and Lab Service for collecting or performing tests on blood or body fluids, handling tissue or preparing slides, or processing, storing and shipping specimens to reference laboratories? FORMCHECKBOX  FORMCHECKBOX If YES, you must meet with Dawn Hornby (extension 58344;  HYPERLINK "mailto:Dawn.Hornby@va.gov" Dawn.Hornby@va.gov) to determine the total cost to Path and Lab on a per patient basis and enter this information here. Cost per patient:  FORMTEXT       **PLEASE attach the signed cost estimate worksheet from Path and Lab to this document** PART C: Use of Imaging Services3.0Will your study involve the use of VA Imaging Services?  FORMCHECKBOX  FORMCHECKBOX If YES, you must meet with Maria Gallegos (extension 56512) to determine the total cost to Imaging on a per patient basis and enter this information here. Cost per patient:  FORMTEXT       **PLEASE attach the signed cost estimate worksheet from Imaging to this document** PART D: Other Medical Center Services4.0Will your study involve the use of any other Medical Center Services not mentioned above (i.e., ophthalmology, sterile processing unit, etc)?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, please contact Jane Yates (x52800,  HYPERLINK "mailto:Jane.Yates@va.gov" Jane.Yates@va.gov) for additional instructions.PART E: Use of Identifiable DataYesNo5.0If you are using Medical Center Services, will the request for labs, drugs, x-rays, etc. be requested using the patients real name or will the request use a code?  FORMCHECKBOX  Identifiable  FORMCHECKBOX  Coded PLEASE NOTE: For all requests that will use the patients real name, a research clinic must be established. Please contact Sharon Jacky (x58346,  HYPERLINK "mailto:Sharon.Jacky@va.gov" Sharon.Jacky@va.gov) to have a research clinic set-up. Research Clinic Name (once clinic creation has been confirmed):  FORMTEXT      PART F: Source of Research Subjects 6.0Will patients be enrolled from: Inpatient services: Yes  FORMCHECKBOX  No  FORMCHECKBOX  Outpatient clinics: Yes  FORMCHECKBOX  No  FORMCHECKBOX  Emergency care unit: Yes  FORMCHECKBOX  No  FORMCHECKBOX  If YES, list services:  FORMTEXT       Inpatient Enrollment: N/A  FORMCHECKBOX , skip to 6.3 6.1Will patients be hospitalized for the sole purpose of participating in the research protocol?  FORMCHECKBOX  FORMCHECKBOX 6.2Will research subjects be studied in any of the following settings Intensive care unit Yes  FORMCHECKBOX  No  FORMCHECKBOX  # of days  FORMTEXT       Step down unit or monitored bed Yes  FORMCHECKBOX  No  FORMCHECKBOX  # of days  FORMTEXT       Bed on ward Indicate Ward  FORMTEXT       Yes  FORMCHECKBOX  No  FORMCHECKBOX  # of days  FORMTEXT       Outpatient Enrollment: N/A  FORMCHECKBOX , skip to 7.0 6.3Will outpatient  FORMTEXT      visits be held in an exam room/clinic  FORMCHECKBOX  or PI s private office  FORMCHECKBOX  ? 6.4If clinic indicate which one:  FORMTEXT       6.5Clinic location:  FORMTEXT       Length of Clinic Visit (research portion only):  FORMTEXT       PART G: Additional Information7.0How many Portland VAMC patients will be enrolled over the life of the study?  FORMTEXT       7.1What is the maximum length of time a patient will be enrolled?  FORMTEXT       7.2On a per patient basis, what is the maximum number of individual clinic visits projected over the length of the study?  FORMTEXT       7.3On a per patient basis, how many of these visits represent additional outpatient visits scheduled solely as a result of the patient s participation in the research protocol?  FORMTEXT       7.4Are there financial benefits to the Portland VA as a result of participating in this research (e.g., nursing support, laboratory tests, PI time volunteered to VA, free study drug to replace a drug used in standard of care)?   FORMCHECKBOX   FORMCHECKBOX If YES, please describe:  FORMTEXT       YesNo7.5Will the protocol involve patients hospitalized or recruited from outpatient clinics on a service other than your own (e.g., protocol from an investigator in Medical Service that would include patients from Psychiatry Service)?  FORMCHECKBOX   FORMCHECKBOX If YES, which service is involved?  FORMTEXT       If YES, have you discussed this protocol with the Chief of that service?   FORMCHECKBOX   FORMCHECKBOX 7.6Will the workload of fellows, residents, students, or nurses be impacted while caring for patients enrolled in your protocol?  FORMCHECKBOX   FORMCHECKBOX If YES, have you discussed this with the Chief of the appropriate service? 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FORMCHECKBOX  FORMCHECKBOX If YES, have you discussed this with the ACOS/Extended Care?  FORMCHECKBOX  FORMCHECKBOX  (The following are examples of how to complete sections II. Replace each section with the information specific to your study. Add extra pages if necessary.) Section II: All Aspects of Care Table: (Prepared by PI, see example below) S: Standard care, not reimbursed in budget SR: Standard care, Reimbursed in budget C: Research test performed at a Core laboratory (i.e., outside lab  not the VA lab) RR: Research Related expense A blank box would indicate that the test or procedure did not occur on the day or clinic visit in question. List only encounters that will occur at the PVAMC. For laboratory tests, list all individual tests, not panels. For example, for drug screens, list all drugs for which you will test. PLEASE NOTE: This section of the document is modifiable. Test/ Procedure/ Setting Day 1 Day 2 Day 3 Day 4 Week 1 Week 2 Week 3 Week 4 Mo 6 Mo 9 Mo 12Total RRTotal SREchoSECGSRRRRRRSRRRRRRSRRS7Holter MonitorSRRSR11CT ScanSR1Chest X-raySICU BedSBlood Draw by VA Lab for Core LabsCCOutpatient clinicRRRRRRSSRRS4CBCCCRRSRRRSRSRRRC33BUNCCRRSRRRSRSRRRC33 Costs will be calculated by each individual service using the Decision Support Systems (DSS) database Section III: Study Budget You must submit a copy of the study budget showing the amount of funds that will be provided and on what timetable, even if the budget is still under negotiation. If the grant is a yearly sum, a budget breakdown must be provided for each year. If funds are to be provided on a per patient basis, a payment schedule should be agreed to in advance with the funding agency and a copy of this should be included. Indirect costs must be requested as per the policies of the institution that is administering the funds, i.e., OHSU or PVARF. If allowed by the funding agency, salary should be requested for the PI and VA IRB fees should be requested. Standard IRB fees for the VA IRB are: Initial Review $3,000 Continuing Review $500 Amendments/Modifications $750 Salary and IRB fees should always be requested from for-profit companies. Budget page attached: Yes  FORMCHECKBOX  No  FORMCHECKBOX  Not Applicable (Unfunded Study)  FORMCHECKBOX  If no budget page is attached, and the study is funded, provide documentation, e.g., copy of subcontract from OHSU and explain below.  FORMTEXT insert explanation here Will this work be done if the study is not funded? Yes  FORMCHECKBOX  No  FORMCHECKBOX  If YES and Research Service determines that there will be research-related costs to the VA for this study, Research Service will seek permission from the PI s Service Chief and/or the Executive Management Team (EMT) to allow the study to occur. The study cannot begin without this approval.     PAGE 2 Revised 05/05/2017 MIRB No. (office use only) ______________ If you have questions about this form or the Financial Administrative Review process, contact Jane Yates (VA x52800,  HYPERLINK "mailto:Jane.Yates@va.gov" Jane.Yates@va.gov).  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