ࡱ> 352 bjbj 8!,,XXXXX333|~~~~~~$Y 33  XX  XX| |<X *Д,h04! ! <! <,3L6,)333333    ! 333333333 : Checklist for Institutional Risk Assessment for Externally-Sponsored Investigator-Initiated Clinical Trials Date Submitted to ORPA___________ Principal Investigator:____________________________________ Dept. __________________________________________________ Phone:____________ Email:______________________________ External Sponsor________________________________________ (If UR is a sub-site, provide name of prime sponsor as well) To be provided by department: ___ Copy of RSRB application if available ___ Copy of most recent version of protocol ___ Copy of RSRB model consent form ___ Copy of the Faculty Questionnaire (attached) To be provided by ORPA: ___ Copy of latest draft/final contract (supplied by ORPA) Indicate level of Indemnification offered by sponsor: ___ Product Liability ___ Use of results ___ None ___ Other:_____________________________________ Additional Comments: ________________________________________________________________________________________________ ORPA Research Administrator: ___________________________________ Date Scheduled for Committee: _____________ Date Submitted to Dean: _________________ H:/dept/forms/Risk Assessment Checklist 5/18 Ģý Risk Assessment Faculty Comments Please answer the following questions to bring forth or clarify issues that might be helpful during the Universitys risk assessment review process. What are the unique risks inherent in the study protocol, if any? What is your assessment of these risks in comparison to the benefits gained from the study? What do you believe is the worst case scenario with respect to potential risk and/or subject injury? Why should the University bear the risks that the sponsor is unwilling to assume? Is the immediate health of the subjects/patients at risk if this trial does not go forward? Explain how future outcomes of this trial might directly benefit you or the University, e.g., future grant applications, publications, discoveries/patents, career path? Are there any other special circumstances with respect to this trial that the University should consider in its risk assessment? H:/dept/forms/risk assessment PI comments 1-07 mny   ( 8 < E J ^ i   9 : @ X y } ~ ȽȽȩȩȩȩȩȩȩȩ䴊}hSs 5OJQJhh5OJQJh56OJQJh}5CJOJQJh5CJOJQJh^T5OJQJh^T56OJQJh^T5CJOJQJh^T5CJOJQJ h^TCJh^Th^T5CJ OJQJh^T5>*CJOJQJ01mn @ y   2 3 X Y  $ a$ h$ ha$$a$  0 D N  : ; g 3 & F gd} hgd h^TB* CJOJQJphh^TCJOJQJh^TOJQJh^T hSs 5 h^T5 h}5 34567: & Fh>TTf^hgd} & F gd}6 & F>TTfgd}UVWXYyh^h6 & F>TTfgd}: & Fh>TTf^hgd} & F gd}6hxhxhxhxhxhxhxhxhx?o??o??o?P8$:p}/ =!"#$8% Dp^ 2 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH L`L Normal5$7$8$9DH$CJ_HmH sH tH @@@  Heading 1$@& 5OJQJX@X  Heading 2$$@&^`a$56OJQJD@D  Heading 3$@&5CJOJQJDA D Default Paragraph FontViV  Table Normal :V 44 la (k (No List @@@ Balloon Text CJOJQJPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭V$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! I_TS 1?E??ZBΪmU/?~xY'y5g&΋/ɋ>GMGeD3Vq%'#q$8K)fw9:ĵ x}rxwr:\TZaG*y8IjbRc|XŻǿI u3KGnD1NIBs RuK>V.EL+M2#'fi ~V vl{u8zH *:(W☕ ~JTe\O*tHGHY}KNP*ݾ˦TѼ9/#A7qZ$*c?qUnwN%Oi4 =3N)cbJ uV4(Tn 7_?m-ٛ{UBwznʜ"Z xJZp; {/<P;,)''KQk5qpN8KGbe Sd̛\17 pa>SR! 3K4'+rzQ TTIIvt]Kc⫲K#v5+|D~O@%\w_nN[L9KqgVhn R!y+Un;*&/HrT >>\ t=.Tġ S; Z~!P9giCڧ!# B,;X=ۻ,I2UWV9$lk=Aj;{AP79|s*Y;̠[MCۿhf]o{oY=1kyVV5E8Vk+֜\80X4D)!!?*|fv u"xA@T_q64)kڬuV7 t '%;i9s9x,ڎ-45xd8?ǘd/Y|t &LILJ`& -Gt/PK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 0_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!0C)theme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK]     3 8@0(  B S  ?3N3N3N3N3N}}9*urn:schemas-microsoft-com:office:smarttagsplace8*urn:schemas-microsoft-com:office:smarttagsCity=*urn:schemas-microsoft-com:office:smarttags PlaceType=*urn:schemas-microsoft-com:office:smarttags PlaceName    5<[b%28FMPX3333333333333  (8<EJ^i9::@Xy~  (8<EJ^i9::@Xy~rnx:Ca@xh^`CJ)rnxSs }^T@@UnknownG*Ax Times New Roman5Symbol3. *Cx Arial?= *Cx Courier New;Wingdings5. .[`)TahomaA$BCambria Math"hee:FMoMo!xx243QHP ?}2!xx +Checklist for Institutional Risk AssessmentHP Authorized CustomerDonna L. Beyea Oh+'0  0 < H T`hpx,Checklist for Institutional Risk AssessmentHP Authorized CustomerNormalDonna L. Beyea2Microsoft Office Word@F#@#@@Mo՜.+,0( hp  Ģý ,Checklist for Institutional Risk Assessment Title  !#$%&'()+,-./014Root Entry FDД61Table1 WordDocument8!SummaryInformation("DocumentSummaryInformation8*CompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q