ࡱ> AC@ ,bjbj>> ;0pTpTnn8,@<f|||||WWW_aaaaaa$4QWWWWW||W||_W_|)[ERK0hWWWWWWW=WWWWWWWWWWWWWWWWn : Adverse Event Log Has the subject experienced any adverse events? m YES NO (Complete at End of Study) Record all Adverse Events that occur during the study period (may be defined as  from signing consent to conclusion of study participation . Elicit adverse event information by asking open-ended questions, e.g. What unusual symptoms or medical problems have you experienced since the last study visit? Record any new or change in ongoing signs and/or symptoms as well as any event that has resolved since the last evaluation. IF EVENT IS A SERIOUS ADVERSE EVENT (SAE), you may need to complete additional reporting and/or documentation for the IRB or Sponsor. Consult approved protocol and applicable policies to determine reporting responsibility. AE #Adverse Event DescriptionStart/Stop DatesSeverityAction taken with Study DrugOutcomeRelation To Study Drug (to be completed by Investigator)Is this a Serious Adverse Event?Investigator Signature and Date1 ___/___/____ Start ___/___/____ Stop  Mild ___ Moderate ___ Severe ___ None ___ Discontinued ___ Interrupted ___  RECOVERED w/o sequela ____ RECOVERED w/ sequela ____ Ongoing ____ Fatal ____ UNK ____ Definite ___ Probable ___ Possible ___ Not Likely ___ Unrelated ___ % Yes * % No 2 ___/___/____ Start ___/___/____ Stop  Mild ___ Moderate ___ Severe ___ None ___ Discontinued ___ Interrupted ___  RECOVERED w/o sequela ____ RECOVERED w/ sequela ____ Ongoing ____ Fatal ____ UNK ____ Definite ___ Probable ___ Possible ___ Not Likely ___ Unrelated ___ % Yes * % No3 ___/___/____ Start ___/___/____ Stop  Mild ___ Moderate ___ Severe ___ None ___ Discontinued ___ Interrupted ___  RECOVERED w/o sequela ____ RECOVERED w/ sequ"$V b B F p ھڕtddTddddhLLhLL5CJOJQJaJh1h{u5CJOJQJaJhA1h1CJOJQJaJ"hA1h^b56CJOJQJaJhA1h^bCJOJQJaJh^b5CJOJQJaJhLL5CJOJQJaJhWDhWD5CJOJQJaJhWDhsa5CJaJhWDhsa5CJOJQJaJhLL5OJQJh{uhLL5OJQJ$   , 5 R Z $If $$Ifa$Ff$H$If^Ha$gdLL $$Ifa$gdLL $$Ifa$gd1h^hgdLL$a$gdLL     & ( 1 ? @ F V  "&,.248:VX^`|h{uh{u5CJOJQJaJh{uh{uCJaJh{uhL-CJOJQJaJhL-CJOJQJaJh1CJOJQJaJh{uh{uCJOJQJaJE    ' ( 2 3 E F W X Y u $IfgdL-$If $$Ifa$gdLL  "$&*,.HTVpz|~ $Ifgd7 $$Ifa$gdLL $$Ifa$Ff$If $IfgdL-(02NRXZlpz| &*@DVrt$$&$:$F$N$R$n$p$$$$$$$$$UhZ(hL-CJOJQJaJh{uhL-5CJOJQJaJh{uhL-CJaJh{uhL-CJOJQJaJhL-CJOJQJaJI*,.f:Zxz $$Ifa$Ffa $Ifgd7  (*BDXZ~$0$H$ $Ifgd7 $$Ifa$gdLL$Ifela ____ Ongoing ____ Fatal ____ UNK ____ Definite ___ Probable ___ Possible ___ Not Likely ___ Unrelated ___ % Yes * % No     University of Rochester Subject Initials & ID # _________________________ Protocol Name &/or #:________H$\$^$z$$$$$$%%%%%%%%"%$%(%*%.%0%`%%%",$a$gd{ugdWDFf3 $Ifgd7$$$$$%%%%%%%%%% %$%&%*%,%0%`%%%%%%%%񬤠ym]J$h{uh&CJOJQJaJmHsHhWDCJOJQJaJmHsHh1CJOJQJaJhZ(CJOJQJaJh{uh{uCJOJQJaJh{uCJOJQJaJh{Nkjh{NkUh{uhsaCJOJQJaJhZ(hL-CJOJQJaJh{uhL-5CJOJQJaJh{uhL-CJaJhL-CJOJQJaJh{uhL-CJOJQJaJ%%%%&, ,",$,,,,,,,,,,,,,~ok\h{uhsaCJOJQJaJh{NkhWDh&CJOJQJaJhLLCJOJQJaJhCJOJQJaJhWDCJOJQJaJhWDh.vCJOJQJaJhWDhWDCJOJQJaJhWDh&$h{uh&CJOJQJaJmHsHUh1CJOJQJaJmHsH$h{uh{uCJOJQJaJmHsH________________ Page ____ of ____ 01APR16 ",$,,,,,gdWD$a$gdLL9&P1h0:pLL= /!"#$% $$If!v h#v#v\#v#v#v\#v ]:V l t0n555\555\5 ]yt{Tkd$$IfTl |!I(.5\\\\\] t0n5$$$$44 layt{T$$If!v h#v#v\#v#v#v\#v ]:V l t0n555\555\5 ]yt{T kd$$IfTl |!I(.5\\\\\] t0n5$$$$44 layt{T$$If!v h#v#v\#v#v#v\#v ]:V l t0n555\555\5 ]yt{T kd$$IfTl |!I(.5\\\\\] t0n5$$$$44 layt{T$$If!v h#v#v\#v#v#v\#v ]:V l t0n555\555\5 ]yt{T kdn$$IfTl |!I(.5\\\\\] t0n5$$$$44 layt{T^ 02 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 FontVi@V  Table Normal :V 44 la (k (No List 6o6 .v0 Footer CharCJaJ4@4 Header  !4 @4 0Footer  !H@"H  Balloon TextCJOJQJ^JaJPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭V$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! 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