ࡱ> NQM 0*bjbj 106 8,4`42X(,`8$1111111$|4.72EW``WW2,4T2!!!W,1!W1!!A/|00VR/1j202/7C7$070! Y22!2WWWW7 :  IRB#  FORMTEXT       SAINT LOUIS UNIVERSITY Institutional Review Board 3556 Caroline St., Room 110 %% phone: (314) 977-7744 %%fax: (314)977-7730 Emergency Treatment Status Update/Closure Form The Saint Louis University IRB requires the treating physician to provide a treatment status update every six months and/or to close when treatment is complete. A closure requires an explanation of the outcome. Investigator: Date of Treatment:: Department: Test article used: E-Mail: Phone: IND/IDE number:  Six months post initial treatment status:  FORMTEXT       OR Closure:  FORMCHECKBOX  Treatment with test article is complete. Outcome explanation:  FORMTEXT       Emergency use is FDA-regulated, so data related to this emergency treatment may be reported to a sponsor and the FDA. Data may not be used for the treating physicians own prospective research. Please note that FDA regulations require that any subsequent use of the test article at the institution (SLU) undergo prospective IRB review and approval. P "$&02468dfh 8 : < d r xlf`Z`fOh^[h[CJ aJ h?fCJ hCJ h[CJ h^[h[5CJ aJ h[5>*CJhfh\Hw5>*CJhfh[5>*CJ hodhodhn;hn;5CJaJh\Hw5CJ aJ hodh\Hw5CJ aJ hodh[5CJ aJ hodCJjhIfpUmHnHujhIfpUhIfpjhIfpUh[hod468h: < $Ifgde?gdD$a$$a$gd 9$a$gdn;gd\Hw$a$ + 2 C G J M ygVHVh~@OJQJ^JaJ hDhD@OJQJ^JaJ#h~hD5@OJQJ^JaJhDhD5@OJQJ^Jh_4[@OJQJ^Jh~@OJQJ^Jh~hD5@OJQJ^JhDhD@OJQJ^JhDh_4[@OJQJ^JhDh_4[5@OJQJ^Jh~h[CJaJh~h[5aJ h?faJ haJ qd[ $Ifgde? $Ifgde?kdt$$Ifs 0_(_ ``0(4 sasp   naPG $Ifgde? =$If^=gde? $IfgdDkdC$$Ifs4 0_(_ ``0(4 sasf4p          H I J T U    & ~lWL@hch5CJaJhch~CJaJ(jhch`CJUaJmHnHu#jWhch`CJUaJhch`CJaJjhch`CJUaJhch[CJaJhchCJaJh~hcB* CJaJphh_4[B* CJaJphh~@OJQJ^JhDhD@OJQJ^Jh~hD5@OJQJ^JhD@OJQJ^J    I   PNNF=Nh^hgd` & Fgd^[kd&$$Ifs4 F/ _(/ 0  ```0(    4 sasf4p   * , .@(B(D(( ) ))~))))  ^` gdn; hh]h^hgdn;gdIgdn; ^gdIfp`gddh^hgdd & Fgdd& ( , . J L N P -.огꨳ|g\XNEhn;5CJ\hn;5>*䴳ڱ[䴳(ڱ䴳Ա#?ڱ䴳ڱ䴳ڱ䴳*䴳䴳#䴳䴳䴳d䴳󰨱䴳.;$%%&&&''':(<(>(@(B(D((((Ĺwj[TNHNH hcCJ hn;CJ hbbhn;h^hcB* CJaJphh^hc0JCJaJ,jh^h 9B* CJUaJphh 9B* CJaJph&jh^hcB* CJUaJphh^hcCJaJh^h?fCJaJh^h?f5CJaJUh^hI5CJaJh^hn;5CJaJh^hn;CJaJh^hICJaJhysicians should carefully consider the likelihood of future use of the test article and submit an IRB Application for review and approval if subsequent use is reasonably likely. Also note that SLU IRB requires a status of treatment update every six months until the treatment is complete. For additional information please refer to the HYPERLINK "https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_emergency_use.doc"Guidance for Emergency Use of a Test Article. ______________________________ _____________________ Signature of Treating Physician Date ______________________________ _____________________ Signature of IRB Designee Date     PAGE 1 PAGE 1 Version 12/2013 (((( ))J)L)|)~)))))))))))))))))))))))**** ****(***,*.*0*{u hIfpCJ hIfpCJ hcCJ h?fCJ hhCJh 90JmHnHuhIfphIfp0JmHnHu hIfp0JjhIfp0JUh6!<jh6!<U h[CJ h?fCJh\Hwhn;CJ hcCJ hn;>*CJ hICJ hn;CJhchn;CJ,)))))))))) ***,*.*0*h]hh]h&`#$/ 0BP/ =!"#$% tDText5$$Ifs!vh#v_#v:V s  ``0(,5_544 sasp$$Ifs!vh#v_#v:V s4  ``0(,5_5/ 44 sasf4p/$$Ifs!vh#v/ #v0 #v:V s4  ```0(,5/ 50 5/ /  / / 44 sasf4ptDText1tDeCheck1tDText2DyK yK 8https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_emergency_use.docyX;H,]ą'c^  002 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH H`H Normal5$7$8$9DH$_HmH sH tH B@B  Heading 1$$@&a$5CJ>@>  Heading 2$$@&a$CJR @R od Heading 9 <@&CJOJPJQJ^JaJDA`D Default Paragraph FontVi@V  Table Normal :V 44 la (k (No List 44 Header  !4 @4 Footer  !.)@. 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