ࡱ> tws Ybjbj 4x5#jj8$x$" $ $ $ $ $ $ $$2&(p-$-$4B$$$!!sY9SR!#X$0$!,T).T)!T)!-$-$$T)j : Ƶ Institutional Review Board (IRB) POST- IRB APPROVAL SUBMISSION REQUIREMENTS Federal regulations require ongoing study oversight by an IRB. Below is a summary of events requiring submission to the IRB after initial approval. Note: if Ƶis acting as coordinating site or holds an IND/IDE for the study, additional reporting is required. Contact the IRB Office at 977-7744 or  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu with questions. Type of EventWhen to SubmitForm to UseReference LinksSERIOUS ADVERSE EVENTS (SAEs) OR UNANTICIPATED PROBLEMS (UPs)Internal SAE involving a death or a life-threatening experienceSubmit within 3 days of the eventSAEs or SAE/UPs: SAE Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Serious_Adverse_Event.doc"SAE Form for paper Internal UPs: Report Form in eIRB; External UPs: Amendment in eIRB; All UPs: HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol for paper HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject Safety HYPERLINK "http://www.slu.edu/Documents/research/IRB/Instructions_4_completing_SAE.doc"Instructions for completing the SAE formOther Internal SAEs; Unanticipated Problems External UPs only require reporting if changes to the protocol are required (see Changes to Protocol section, below)Submit within 7 calendar days SAFETY ALERTS, PARTICIPANT COMPLAINTS, AUDITS, DSM REPORTS, PROTOCOL VIOLATIONS, PROTOCOL DEVIATIONS, PARTICIPANT BECOMES PRISONER/WARDSafety Alert or other information that suggests a change to a risk or benefit of the research (not deemed to be a UP)Submit within 10 working days Report Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocols HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject Safety Serious subject complaints or those that investigators cannot resolve; data security incidents/loss of confidentialityNotify IRB in time to resolve; report form within 7 daysCall/e-mail to IRB followed by Report Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsAudit Notifications/Reports and Monitoring Reports (if report contains PV, also report as PV) ** Notify IRB prior to federal audits taking place **Audits within 10 working days; monitor reports within 30 daysReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocols Data Safety & Monitoring (DSM) ReportsSubmit within 10 working days of receiptAmendment Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsProtocol Violation (PV) or Protocol Deviation (PD) ** Urgent PDs can be approved by IRB via e-mail prior to official paperwork being submitted. This should be done if implementing procedures for subject safety prior to receiving IRB approval. **PD before implementing PV within 7 calendar days of becoming knownReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsParticipant becomes a prisoner or ward of the state during participation in the studyNotify IRB before continuing participationReport Form in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form for paper protocolsCHANGES TO PROTOCOL, FINAL DSMB CHARTERS, UPDATED IBsChanges to IRB-approved Protocol, Personnel, Consents, Recruitment Materials, Questionnaires, etc; Updated Investigators Brochure (IB); Final Versions of DSMB Charter (if part of protocol) ** Amendments relating to subject safety should be submitted promptly. If new procedures must be implemented on urgent basis for subject safety, also see PD section, above. **Submit promptly. If external UP, within 7 days. Do not implement changes prior to IRB approval unless for subject safety (see PD). Amendment in eIRB; HYPERLINK "http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.doc"Change-in-Protocol/ For Information Form  HYPERLINK "http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.doc"Guidelines for Reporting Events Related to Subject SafetyCONTINUING REVIEWSContinuing Reviews (CR) are required by federal regulations no less than once annually. ** Be aware of expiration date and IRB deadlines. As a courtesy, the IRB will send reminder notifications, but the PI is ultimately responsible for submitting the CR form. **  Submit at least 4-6 weeks before IRB approval expires.  Continuing Review Form in eIRB;  HYPERLINK "http://www.slu.edu/Documents/research/IRB/Continuing_Review_Form.doc" Continuing Review Form for paper protocols  NOTICE OF STUDY CLOSUREFor non-exempt protocols, submit when study is completed or will discontinue. See Reference LinkFinal Report in eIRBHYPERLINK "http://www.slu.edu/Documents/research/IRB/Study_Closure_Guidance.doc" \t "_blank"Closure of Human Research StudiesRECORD RETENTIONResearch records for studies involving human subjects must be retained for at least 3 years (6 years if HIPAA applies) after the completion of the study (closure of study). This is a federal requirement. Note: study sponsors may have additional requirements.     Version Date: 8/2019 9:LMXdef xgVVAVA)jhGhO%CJOJQJU^JaJ hGhO%CJOJQJ^JaJ hGh{CJOJQJ^JaJ hGhgCJOJQJ^JaJ hGh!^CJOJQJ^JaJ hGhY5gCJOJQJ^JaJhGhO CJaJha5OJQJ^Jh%5OJQJ^J#h{hY5g5CJOJQJ^JaJhah5OJQJ^Jh~5OJQJ^JhY5g5OJQJ^J9:ef $$Ifa$gdI}\$a$gdah$a$gdD$a$gdY5g  H I J S ǶsasP?1hCJOJQJ^JaJ hI}\hahCJOJQJ^JaJ hI}\hahCJOJQJ^JaJ#hI}\hah5CJOJQJ^JaJhah5CJOJQJ^JaJ hI}\h{CJOJQJ^JaJ#hI}\h{5CJOJQJ^JaJ hGhaCJ OJQJ^JaJ hGhTCJOJQJ^JaJ hGhO%CJOJQJ^JaJ)jhGhO%CJOJQJU^JaJ$hGhO%0JCJOJQJ^JaJ I +" $IfgdY5gkd$$Ifl\,f!0*   t(0644 lap(yt=6I J 5 6 + |ssj|sss $Ifgdt $Ifgd-Y $IfgdGzkd$$Ifl0**  t 0644 lap yt& S V  ! ) * 4 ӾyaJ9 h!^h aCJOJQJ^JaJ-h!^hb0JB*CJOJQJ^JaJph/jh!^hM}CJOJQJU^JaJ h!^hM}CJOJQJ^JaJ)jh!^hbCJOJQJU^JaJ hI}\h!^CJOJQJ^JaJh!^CJOJQJ^JaJ)h!^h!^B*CJOJQJ^JaJphhm5CJOJQJ^JaJ hI}\hbCJOJQJ^JaJh0CJOJQJ^JaJ4 5 6 ? D W X Y g q x ŰjUD,U/jh!^hM}CJOJQJU^JaJ h!^hM}CJOJQJ^JaJ)jh!^hm5CJOJQJU^JaJ)h!^h0B*CJOJQJ^JaJph#h0B*CJOJQJ^JaJph hI}\h!^CJOJQJ^JaJh!^CJOJQJ^JaJ)h!^h!^B*CJOJQJ^JaJphhm5CJOJQJ^JaJh0CJOJQJ^JaJhtCJOJQJ^JaJ h!^hbCJOJQJ^JaJ f g h s ±vfSB-)jhI}\h 5CJOJQJU^JaJ hI}\h 5CJOJQJ^JaJ$hI}\h)x0JCJOJQJ^JaJh00JCJOJQJ^JaJ/jhI}\hM}CJOJQJU^JaJhM}CJOJQJ^JaJ)jhI}\hbCJOJQJU^JaJ hI}\hbCJOJQJ^JaJ h!^hm5CJOJQJ^JaJ)jh!^hm5CJOJQJU^JaJ-h!^hm50JB*CJOJQJ^JaJph  ) * + , 2 ; ? A V W X Y Z ҿҮsaSA#hI}\h 55CJOJQJ^JaJhm5CJOJQJ^JaJ#hGh06CJOJQJ^JaJhbCJOJQJ^JaJh0CJOJQJ^JaJhCJOJQJ^JaJ hI}\hbCJOJQJ^JaJ hI}\hbCJOJQJ^JaJ$hI}\h 50JCJOJQJ^JaJ)jhI}\h 5CJOJQJU^JaJ/j#hI}\hM}CJOJQJU^JaJ+ , Y Z I@@@7 $Ifgdm5 $IfgdGkdD$$Ifl4\,f!0*` ` t0644 lapyt=6 Cz@77 $IfgdGkd$$Ifl4\,f!0*   t0644 lapyt=6 $Ifgd-Y  +-@LVy{#$%&~пudLu/jh!^hiCJOJQJU^JaJ h!^hiCJOJQJ^JaJ)jh!^hiCJOJQJU^JaJ#hiB*CJOJQJ^JaJph)h!^hiB*CJOJQJ^JaJphhiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJ hI}\h 5CJOJQJ^JaJhi5CJOJQJ^JaJh5CJOJQJ^JaJz{||sjjjjjjjj $Ifgd)x $Ifgd!^ $IfgdY5gzkd$$Ifl0**  t 0644 lap ytI}\ /01<jkpq !@±vfSB hI}\hiCJOJQJ^JaJ$hI}\hi0JCJOJQJ^JaJhi0JCJOJQJ^JaJ/j hI}\hiCJOJQJU^JaJ)jhI}\hiCJOJQJU^JaJhiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJ h!^hiCJOJQJ^JaJ)jh!^hiCJOJQJU^JaJ-h!^hi0JB*CJOJQJ^JaJphopq7. $IfgdGkd $$Ifl4\,f!0* ` t0644 lapyt=6 $Ifgdq* $Ifgd)x!@ $IfgdY5g $Ifgd!^ $IfgdI  $IfgdB9@@STUV"1DzǚrarSrSrSrSrDzhiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJ-h!^hi0JB*CJOJQJ^JaJph/j h!^hiCJOJQJU^JaJ)jh!^hiCJOJQJU^JaJ h!^hiCJOJQJ^JaJ#hiB*CJOJQJ^JaJph)h!^hiB*CJOJQJ^JaJphNOI@@@7 $Ifgdt $IfgdY5gkd $$Ifl4\,f!0*  t0644 lapyt=6123[\`qst567_`dһҪzhSҪ;һҪ/jh!^hiCJOJQJU^JaJ)h!^hiB*CJOJQJ^JaJph#hLB*CJOJQJ^JaJph hI}\hiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJhiCJOJQJ^JaJ h!^hiCJOJQJ^JaJ-h!^hi0JB*CJOJQJ^JaJph)jh!^hiCJOJQJU^JaJ/j h!^hiCJOJQJU^JaJrst7. $Ifgdtkd$$Ifl4\,f!0*  t0644 lapyt=6 $IfgdY5g $Ifgd!^uvw.kd$$Ifl4\,f!0*  t0644 lapyt=6 $IfgdY5g $Ifgd!^ $IfgdKNdtvwmnqwx !"ᩗqYq/jh!^hiCJOJQJU^JaJ)jh!^hiCJOJQJU^JaJ h!^hiCJOJQJ^JaJ#hiB*CJOJQJ^JaJph)h!^hiB*CJOJQJ^JaJph#h hi6CJOJQJ^JaJ hI}\hiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJhiCJOJQJ^JaJwn`a $Ifgd!^ $Ifgdt $Ifgd $Ifgd1T"JKU_abQRS{|´}kS´}A#hI}\hb5CJOJQJ^JaJ/jh!^hiCJOJQJU^JaJ#hiB*CJOJQJ^JaJph)h!^hiB*CJOJQJ^JaJph hI}\hiCJOJQJ^JaJ hI}\hiCJOJQJ^JaJhiCJOJQJ^JaJ h!^hiCJOJQJ^JaJ)jh!^hiCJOJQJU^JaJ-h!^hi0JB*CJOJQJ^JaJphabI@7.@ $Ifgd!^ $Ifgdt $Ifgd1Tkd$$Ifl4\,f!0*   t0644 lapyt}I@ $Ifgd kd$$Ifl4\,f!0*   t0644 lapyt=6-LQSbqòwiw[M?h{CJOJQJ^JaJh_ CJOJQJ^JaJhxCJOJQJ^JaJh=CJOJQJ^JaJhtCJOJQJ^JaJ hI}\h{CJOJQJ^JaJhxCJOJQJ^JaJhV8CJOJQJ^JaJ hI}\hbCJOJQJ^JaJhM5CJOJQJ^JaJhV85CJOJQJ^JaJh}i5CJOJQJ^JaJhx5CJOJQJ^JaJ9ijWXY||sjjj||||| $Ifgdi $Ifgd $IfgdY5gzkd$$Ifl0**  t 0644 lap ytI}\ 89@k±ӱӱkYH3)jh!^h{CJOJQJU^JaJ h!^h!^CJOJQJ^JaJ#h!^B*CJOJQJ^JaJph)h!^h!^B*CJOJQJ^JaJph#hiB*CJOJQJ^JaJphh}CJOJQJ^JaJ hI}\h{CJOJQJ^JaJ hI}\hiCJOJQJ^JaJ hvZXhvZXCJOJQJ^JaJhiCJOJQJ^JaJ hvZXhiCJOJQJ^JaJhvZXCJOJQJ^JaJ+,-UVWXYZ[\«~pbMp5M/jJhI}\h0CJOJQJU^JaJ)jhI}\h0CJOJQJU^JaJhiCJOJQJ^JaJh0CJOJQJ^JaJ hI}\hV8CJOJQJ^JaJhV8CJOJQJ^JaJh{CJOJQJ^JaJ-h!^h{0JB*CJOJQJ^JaJph)jh!^h{CJOJQJU^JaJ/j'h!^hM}CJOJQJU^JaJ h!^hM}CJOJQJ^JaJYZ[B99 $IfgdY5gkd$$Ifl\,f!0*  t0644 lapyt=6 $Ifgdbpqu "#$ȷrdSdS?1h}CJOJQJ^JaJ&h~h{56CJOJQJ^JaJ hV:hO%CJOJQJ^JaJhO%CJOJQJ^JaJ hI}\h 5CJOJQJ^JaJ hI}\h{CJOJQJ^JaJ#hI}\h{5CJOJQJ^JaJ hI}\h{CJOJQJ^JaJ hI}\hbCJOJQJ^JaJ)jhI}\h0CJOJQJU^JaJ$hI}\h00JCJOJQJ^JaJh00JCJOJQJ^JaJ"kd`$$Ifl\,f!0*   t( 0644 lap( yt=6 $IfgdY5gq#$\] $Ifgdl $Ifgd~ $IfgdY5g $5\]{|}~лrZCr5hCJOJQJ^JaJ-h!^h0JB*CJOJQJ^JaJph/jeh!^hCJOJQJU^JaJ h!^hCJOJQJ^JaJ)jh!^hCJOJQJU^JaJ h!^h!^CJOJQJ^JaJ#h!^B*CJOJQJ^JaJph)h!^h!^B*CJOJQJ^JaJphh}CJOJQJ^JaJ hI}\h{CJOJQJ^JaJ hI}\hcCJOJQJ^JaJ 9Ⱥm\Q@/ h8.h8.CJOJQJ^JaJ hI}\h8.CJOJQJ^JaJh8.h8.CJaJ hI}\h8.CJOJQJ^JaJ,h8.h8.5B*CJOJQJ^JaJph&h8.5B*CJOJQJ^JaJph hI}\h{CJOJQJ^JaJ hI}\hlCJOJQJ^JaJhKNCJOJQJ^JaJ hI}\hpCJOJQJ^JaJ hI}\h{CJOJQJ^JaJ)h!^h{B*CJOJQJ^JaJph I@@@@ $IfgdY5gkdx$$Ifl\,f!0*  t0644 lapyt=6 o+" $IfgdY5gkdO$$Ifl\,f!0*   t(0644 lap(yt=69mo+.лr_N<+ hI}\h'CJOJQJ^JaJ#hI}\h'5CJOJQJ^JaJ hI}\h8.CJOJQJ^JaJ$h8.h8.0JCJOJQJ^JaJ8jbh8.hM}B*CJOJQJU^JaJph#hM}B*CJOJQJ^JaJph2jh8.h8.B*CJOJQJU^JaJph)h!^h8.B*CJOJQJ^JaJph hI}\h8.CJOJQJ^JaJ h8.h8.CJOJQJ^JaJh8.CJOJQJ^JaJo+kd$$Ifl\,f!0*  t0644 lap(yt=6 $Ifgdah $IfgdY5g $Ifgd8.+,-. $IfgdY5g./3+" $Ifgdfkdd$$Ifl\,f!0*   t(0644 lap(yt=6./?ei2345689;<>?AOPTUVWXYͿͭͿxmihth'htCJaJh0CJaJh")CJaJh=6CJaJh jh U hphgCJOJQJ^JaJ#hI}\h'>*CJOJQJ^JaJhfCJOJQJ^JaJ hI}\h'CJOJQJ^JaJ hI}\h aCJOJQJ^JaJ hI}\h'CJOJQJ^JaJ34578:;=>@AVWXYgdLqkdw $$Ifl0** t0644 lap ytI}\21h:p^/ =!"# $ % $$If!vh#v#v#v #v:V l  t(06555 5/ p(yt=6$$If!vh#v*:V l  t 065*p yt&DyK yK http://www.slu.edu/Documents/research/IRB/Serious_Adverse_Event.docyX;H,]ą'c#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'cCDyK yK http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docyX;H,]ą'c!DyK yK http://www.slu.edu/Documents/research/IRB/Instructions_4_completing_SAE.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06++555 5pyt=6$$If!vh#v#v#v #v:V l4 t06++555 5pyt=6$$If!vh#v*:V l  t 065*p ytI}\#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'cCDyK yK http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5pyt=6#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5pyt=6#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5pyt=6#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5/ pyt=6#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5/ pyt}#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l4 t06+555 5/ pyt=6$$If!vh#v*:V l  t 065*p ytI}\#DyK yK http://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docyX;H,]ą'cCDyK yK http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docyX;H,]ą'c$$If!vh#v#v#v #v:V l t06555 5/ pyt=6$$If!vh#v#v#v #v:V l  t( 06555 5p( yt=6DyK yK http://www.slu.edu/Documents/research/IRB/Continuing_Review_Form.docyX;H,]ą'c$$If!vh#v#v#v #v:V l t06555 5/ pyt=6$$If!vh#v#v#v #v:V l  t(06555 5/ p(yt=6%DyK _blankyK http://www.slu.edu/Documents/research/IRB/Study_Closure_Guidance.docyX;H,]ą'c$$If!vh#v#v#v #v:V l t06555 5/ p(yt=6$$If!vh#v#v#v #v:V l  t(06555 5/ p(yt=6$$If!vh#v*:V l t065*p ytI}\^ 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 @`@ NormalCJ_HaJmH sH tH DA D Default Paragraph FontRi@R  Table Normal4 l4a (k (No List >@> Y5g Footnote TextCJaJ@&`@ Y5gFootnote ReferenceH*jj g Table Grid7:V04@"4 NHeader  !4 24 NFooter  !6U`A6 R%t Hyperlink >*B*phFV`QF uFollowedHyperlink >*B* ph.)a.  5 Page NumberH@rH  Balloon TextCJOJQJ^JaJNoN  Balloon Text CharCJOJQJ^JaJH`H a No SpacingCJ_HaJmH sH tH PK![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] Yx """""% S 4 @1d"$9.Y "%'*,-/236: I + zwaYo.3Y!#$&()+.0145789; )g)%0jU 2 [ 6 _ !JR{,U[}YXXXXXXXXXXXXXXXX@ @H 0(  0(  B S  ? _Hlt141667652Z@ZSWtx#O S w{578:;=>@AWZ578:;=>@AWZ3deSS44hhss;;    --CCkk   m m q88Z[q"445588AUZdeSS44hhss;;    --CCkk   m m q88Z[q"4455788:;=>@AUWZP7Nn$ h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hHP7         yxG~cQp # _ L}Y#pX:Dl~0I ")$vc$%O%q*8.i.Q23L3 5m5=6>B9@jD;FgFJIN)QmRTXvZX-Y][I}\!^V` a#f+fY5gah}iulzNq7rTstR%tu)x}MtxV8KNXI@.K k>Aa0&^ dgM}8i@94Q;Tx3cF(x1T{|a1fRTGM|:VdWT 'Xb[MO { [x=N57@4444Y@UnknownG*Ax Times New Roman5Symbol3. *Cx Arial5. .[`)Tahoma;Wingdings?= *Cx Courier NewA$BCambria Math"qh7|x7|x2Tv *v *! 24** 3QHP ?Y5g2!xx Saint Louis Universityhrichmillinrm Oh+'0x  ( 4 @ LX`hpƵhrich links fixed Normal.dotm millinrm3Microsoft Office Word@F#@0ٮ@RS@RSv՜.+,D՜.+,X hp  Ƶ* * Ƶ Title  8@ _PID_HLINKSA `B[-Ehttp://www.slu.edu/Documents/research/IRB/Study_Closure_Guidance.docb{*Ehttp://www.slu.edu/Documents/research/IRB/Continuing_Review_Form.docv']http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docs$Mhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docs!Mhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docv]http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docf Lhttp://www.slu.edu/Documents/research/IRB/Instructions_4_completing_SAE.docv ]http://www.slu.edu/Documents/research/IRB/Requirements_4_Reporting_Events_Subject_Safety.docsMhttp://www.slu.edu/Documents/research/IRB/Change_in_Protocol_4_Info_Form.docaiDhttp://www.slu.edu/Documents/research/IRB/Serious_Adverse_Event.doc^mailto:irb@slu.edu  !"#$%&'()*+,-./0123456789:;<>?@ABCDEFGHIJKLMOPQRSTUVWXYZ[\]^_`abdefghijlmnopqruvyRoot Entry FY9SxData = 1TableNd)WordDocument 4xSummaryInformation(cDocumentSummaryInformation8kMsoDataStoreX9SsY9SNW2GF1CNS==2X9SsY9SItem  PropertiesUCompObj r   F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q