ࡱ> O bjbj s䄐e䄐e AAAAA$eeePe4.p# # # W!${"#H3333333$m8#;j3AO#W!W!O#O#3AA# # 4w46]%]%]%O#FA# A# 3]%O#3]%]%r.T/# PG#R.34<4.;#;//&;A/O#O#]%O#O#O#O#O#33$O#O#O#4O#O#O#O#;O#O#O#O#O#O#O#O#O# : Office of Research Subjects' Protections |  HYPERLINK "http://www.evms.edu/" \o "http://www.evms.edu/" WWW.EVMS.EDU | Andrews Hall | 721 Fairfax Avenue, Ste. 128 | P.O. Box 1980 | Norfolk, VA 23501-1980 | Submission Cover Sheet For Advarra, Inc IRB Studies (All fields on the form must be typed with the exception of signatures/initials. Handwritten forms are not accepted.) CIRBI IRB#:Pro FORMTEXT      EVMS Grant #:  FORMTEXT       Principal Investigator Contact InformationName: FORMTEXT      Phone: FORMTEXT      E-Mail:  FORMTEXT       IMPORTANT: The PI of the study must make the electronic submission of the protocol to Advarra. Any individual can enter the submission into the CIRBI program and serve as the Contact Person, but the final submission, must be made by the PI logging into CIRBI and choosing Submit. Contact Person for this SubmissionName:  FORMTEXT      Phone:  FORMTEXT      E-Mail:  FORMTEXT       Sponsor: FORMTEXT      Sponsor s Protocol #: FORMTEXT      Study Title: FORMTEXT       LIST ALL CO-INVESTIGATORS, RESEARCH TEAM MEMBERS, AND/OR CC RECIPIENTSNameDepartment / AddressStatusINTERNAL USE ONLYHSPCOI FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  FORMTEXT       FORMTEXT       FORMDROPDOWN  CONFLICT OF INTEREST POLICY (COI submissions must be made directly to the Office of Research, Waitzer Hall, 757-446-8480)Do you have a sponsored project? If yes, answer questions 1-3 below; if no, skip to next section FORMCHECKBOX  No FORMCHECKBOX  YesEven if you answered No to all of the questions in the Advarra application but a COI exists based on EVMS policy/VA state regs then you must make a submission to the Institutional Official. If a COI does exist, you need to add that information on your Advarra submission by inserting VA state laws regarding Financial Conflict of Interest where appropriate. You also must add a disclosure to the consent form that you are submitting to Advarra for review. Refer to the Office of Research Policy on Conflicts of Interest in Research and Sponsored Projects ( HYPERLINK "http://www.evms.edu/research/research_administration/conflicts_of_interest_coi_for_grants_and_contracts/" COI). For questions regarding the COI Policy contact the Office of Research at 446-8480. Notes: Investigator is defined by the policy as ALL Key Personnel (Principal Investigator (PI), Project Director and other person identified as senior/key personnel) listed in a grant application, contract, progress or other report, and any other individuals, regardless of title or position, who have responsibility over the design, conduct, or reporting of research or a sponsored project, which may include research assistants, post-docs, fellows, students, collaborators or consultants. Sponsored project is any project that receives funding, supplies, equipment or other materials from a third party. If you have a sponsored project do you attest that prior to or contemporaneously with this application a Proposal Approval Form or an Office of Research Grant/Contract Compliance Form, which identifies all individuals who the PI has deemed as an Investigator, has been completed for this study and submitted to the Office of Research, Waitzer Hall. FORMCHECKBOX  YesIf you have a sponsored project, do you attest that each person deemed by the PI as an Investigator has completed a Disclosure of External Financial and Time Commitments Form and it is on file with the Office of Research to indicate that the Investigator is in compliance with the EVMS COI Policy? FORMCHECKBOX  YesIn addition, any research team member (RTM) who has a financial interest in the sponsor must do the appropriate filing. Do you attest that each RTM who meets this criterion has completed a Disclosure of External Financial and Time Commitments Form and it is on file with the Office of Research? FORMCHECKBOX  YesIf your project is sponsored and you cannot answer YES to all of the above (items 1-3) you must meet the COI Policy requirements before you can proceed with an application to the IRB. Signature for Principal Investigators CertificationIt is necessary for each PI to verify the scientific merit of a new study before submitting the study for IRB review. Based on information submitted by the principal investigator, the appropriate department chair (or designee), certifies the conduct of the study under his/her department. 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Advarra requires that sponsors sign an agreement indemnifying Advarra. Before submission, the investigator is responsible for ensuring that the study sponsor will sign the agreement. In addition, the sponsor/CRO MUST PAY ADVARRA DIRECTLY. If not, the study cannot be sent to Advarra for review and you will need to use an EVMS IRB. Signature for Principal Investigators Certification PI InitialsI agree to pay all costs associated with the review of this protocol if the sponsor fails to pay any IRB fee or related charges.I confirm all of the information provided on this form and agree to all requirements and assurances.PI Signature:______ / ______ / ______ MM DD YY Chairman or Designee Certification: This protocol has been reviewed by me or an appropriate designee and I agree that this study has scientific merit. (If the chair is an investigator on the study, a designee not associated with the study who meets the requirements described in the 2007 EVMS IRB SOPs must sign below.)______________________________________ ______ / ______ / ______ Department Chair/Designee Signature MM DD YY[NOTE: The two items below MUST be completed] Printed Name:  FORMTEXT       Dept Name:  FORMTEXT UfĴƴ#[\]^_`nz˹٧ل|xiWiE1&hc0]h7w5CJOJQJ\^JaJ"h7wh7w5:CJOJQJaJ"h 4lh7w5:CJOJQJaJh7w5:CJOJQJaJhBIhhc0]&hc0]hc0]5CJOJQJ\^JaJhQq25CJOJQJ^JaJ#hc0]hc0]5CJOJQJ^JaJ#hQq2hQq25CJOJQJ^JaJhQq2CJOJQJ^JaJ hc0]hc0]CJOJQJ^JaJ)hc0]hc0]56>*CJOJQJ^JaJ\]^_` $Ifgd@gdc0]ikd6$$Ifl4*+ t064 laf4yt$hXD$<<$If^a$gdG$<<$Ifa$gd+#$dh<<$&d IfP a$gdc0]zkd$$Ifl4*+ @ t 064 laf4p yt-#ȵ#$%.˼˪~jZM@."hc0]h+#6CJOJQJ]^Jh5CJOJQJ^Jh+#5CJOJQJ^Jhc0]h+#5CJOJQJ^J&hc0]h 5CJOJQJ\^JaJ#hc0]hV5CJOJQJ^JaJhy15CJOJQJ^Jh_a5CJOJQJ^J#hc0]hM5CJOJQJ^JaJhy15CJOJQJ^JaJ#hc0]h 5CJOJQJ^JaJ#hc0]hGB5CJOJQJ^JaJ hc0]hMCJOJQJ^JaJ$%n$ !xx$Ifa$gd+#|kd$$Ifl40*r$ t064 laf4ytѶ~~nn !x$Ifgdf x$Ifgdfukd#$$Ifl*+ @ t 064 lap yt-#жѶҶӶͻrbrP4%h+#h pCJOJQJaJ6hh p5:CJOJQJ\aJfHq #hh p5CJOJQJ^JaJh5:CJOJQJ\aJ%hh p5:CJOJQJ\aJ%hfh+#5:CJOJQJ\aJ&hc0]h5CJOJQJ\^JaJhc0]hCJOJQJ^J"hc0]h6CJOJQJ]^J"h7wh56CJOJQJ^Jh56CJOJQJ^J"hc0]h+#5CJOJQJ\^J ѶҶӶqVI $x$Ifgd'?$ppxh&d P ]p^pgd8R`kd$$IflF *r t06    4 laytf,n$$ !<x$Ifa$gd@zkd~$$Ifl4*+ @ t 064 laf4p yt-#"kmnoķŷ*,.Lrz|혇vvbO%h7whGB56CJOJQJ]^J&h;h86CJOJQJ]^JaJ h;h8CJOJQJ^JaJ h;hGBCJOJQJ^JaJh phGB5CJOJQJaJh-#CJOJQJ^JhqCJOJQJ^Jh pCJOJQJ^Jhc0]h pCJOJQJ^J#h ph$V5CJOJQJ^JaJ#h phGB5CJOJQJ^JaJ,..ҹn[[H$ !<<$Ifgd-#$ !xx$Ifgd;$ t<<$Ifgd;$ t<<$Ifgd8kkd/$$Ifl4*+ t064 laf4yt@,.fn¹ĹιйҹڹDzLjycJ9+h7wCJOJQJ^JaJ h8R`hGBCJOJQJ^JaJ0jh8R`h8R`OJQJU^JaJmHnHu+jh8R`h8R`OJQJU^JaJh8R`h8R`OJQJ^JaJ%jh8R`h8R`OJQJU^JaJ,hw hGB5>*CJOJQJ\]^JaJ)hw hGB5CJOJQJ\]^JaJ h;hGBCJOJQJ^JaJ&h;h;6CJOJQJ]^JaJ&h;hGB6CJOJQJ]^JaJ"$(*.>@JL욋xtxtxtxth\M:%jhhd3CJOJQJUaJhhd3CJOJQJaJhd3CJOJQJaJhFCJOJQJaJh,kjh,kUh8R`h4CJaJh;hGBCJOJQJaJ#h-#hGB5CJOJQJ^JaJ0jh8R`h8R`OJQJU^JaJmHnHu+j1h8R`h8R`OJQJU^JaJUh8R`h8R`OJQJ^JaJ%jh8R`h8R`OJQJU^JaJ          Feb 2023 Page  PAGE 2 of  NUMPAGES 3 PI Initials: ____________ Nov 2022 Page  PAGE 1 of  NUMPAGES 3 PI Initials: ____________ Nov 2022 Page  PAGE 3 of  NUMPAGES 3  "&(,.ytrtrtrtrh 0*gdd3gd$a$gdy1~kd$$Ifl4q0P*L t064 laf4ytAK LXZ\^fh~º|mZmZZmZmZZRh+#OJQJ%jhhCJOJQJUaJhhCJOJQJaJhAKCJOJQJaJhy1CJOJQJaJh(6h 4lhd3OJQJh 4lhOJQJh+#h5OJQJhOJQJhhOJQJ!hQq2CJOJQJaJmHnHu%jhhd3CJOJQJUaJhhd3CJOJQJaJ NP$a$gdy1 0*gdd3gdAK 0*gdAKgdd306NP`blnz|~ĵ{wshh8R`h4CJaJh,khh 4lhlOJQJhhlOJQJ!hQq2CJOJQJaJmHnHu%jhhlCJOJQJUaJhhlCJOJQJaJhlCJOJQJaJhy1CJOJQJaJh(6h 4lhOJQJh+#OJQJh+#h+#5OJQJ9 01F/R :p/ =!"#$% 61F/R :pl/ =!"#$% *Dd '{ 0  # Ab~M-zt{[T~Dnz~M-zt{[TPNG  IHDRnsRGBIDATx^}\UӶMْlz'ҋ ((XP,,Ygy, EPz$! }S7lsg'&-w=;zDZx,}3c:^ٶ6_ˏ'0;ANL zHgز|Dh)JLƺw,#{p_LtkQ æP ̗VzYgllto39|QZlPɸ08cGm"C Fz"MN{ Nof]$tB߃p,\-lpEH$kR|L#E*҉ G.:8)r-v&y f傲(.,P48syv<; \Qdx]+F꣭q.,#bY^Yc<">ԍb$ DT'!k `.gB@Wq;h4yl\ Zّ Przx!-8чB=ωīuAkѽaey&`3&ꋣxCū\^x 1R^{O{i04 # zcY>=Cl2sp@dJ\aaS#f_䣎zy8?(yx%H@[(>!T!DGTP~ 8+r4{DLu:CC&x"t[lĊhSYD%_pt])5^9N%cfu6H?HMZE>$Zٜ/3N2@&骑1k-߸ű8?;<9n)a9Wl ]pzpswkw54tzQ0(Nx"YWXsj͒aeikP;2Na7npGxH41ed8m|\E36CT$[߇\-ȇz"qKJrtOc oCY4.Ilf{F/QsEץёXY5F atUR&JuY1htS 1"/<4DoZ[_VyζPeuDpfwXi' Or)nO_SO|%9uirH) RBm7{VoF E@Y]XTIh|nw|0m-xT#|Mh:$sEi 0iǣ~D[:9%kΟ1hAtĊzc-۽;͇% G6F?ם^(!/zMAC/j㄀D6P*+k{aoi33]z2 [LiT#YߺOɧ; ^_0/n%0e3h'L=Oe)`6W;Թ DC!x\pP;n{ŽvB2922#YşϚ?JZM뎲vvϮxبT#n\BhJi͗ 7fdǚՋbTx,1:Sjxo\83E%|XtBϭ? _crz͋g}Wd 莄p_df8B"'&HiY Bkʭ(+mҤf̒J`@uǣ<Ҹ/H&f8ѶzB&=zk^ixKT[wtuGEp%qDch;gcG}o}vB kXl?T0w 7%D)yB 2-8$;s4yTarDBz"m??>ƴrA1֮"|"<+I8t -<)Zir(6NU5,%a8AȘjhR җ o7 AzX\PayD<&ب&6rE"@@ n"կ{G FP8΢:MZwܿfL0HN9={ˤ9BhZv b ۆc~?|hB!Jt`Cf־0~4dXqN%wXt%v҄k}? 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