ࡱ> NPM` .bjbjss 5<98l&(  *&,&,&,&,&,&,&'h*^,&Q" "",&}&.$.$.$"*&.$"*&.$.$.$t x#^.$f$&0&.$u*#u*.$u*.$8 ;!h.$!T! ,&,&#X &""""   SEQ CHAPTER \h \r 1Adverse Drug Reactions (ADRs) for Clinical Trials Expedited Reporting Summary Form  SEQ CHAPTER \h \r 1Drug Code, Generic, or Brand Name: Sponsor of Clinical Trial: (CR) File Number:Report Submitted By: Contact Name and Telephone Number:Protocol Title / Protocol Number (if applicable): Sponsor's Identification Number for the case: Date of ADR Onset: l Fatal or Life-Threatening Unexpected ADR l All other serious and unexpected ADRsIs there an ongoing clinical trial for this drug in Canada? Yes No l l FOR DETAILED INFORMATION ON ADVERSE DRUG REACTIONS SUBJECT TO EXPEDITED REPORTING REFER TO PART C DIVISION 5 OF THE FOOD AND DRUG REGULATIONS AND E2A 'CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING' HC / ICH GUIDELINES, 1995Is this a followup to a previous report? Yes No l l If yes , date of previous report (s): Reported ADR occured in: l Phase I - III study l Phase IV study l Spontaneous ADR ADR Country of Origin l Canada l Other Has the drug been or is it currently marketed in Canada? If yes, provide DIN.DIN: Has the drug ever been released under the Special Access Programme/ Emergency Drug Release? Yes l No l Is there a clinical trial application for this drug under review in Canada? Yes lmn  F I w x  V Z ^ X <>B&*|VXùѹѹѹѹѹѹѹѹѹѹѯѹѹѹѹѯѩѯѯѯѯѩѹ hlCJhlCJ mH sH hlCJmH sH jhlCJUmH sH  hl5CJ hl5CJhlmH sH jhlUmH sH hljhlUBKlmLkd/$$IfTu40E,`^\4 uaf4T$If$If$a$ ,.  F H WLkdU$$IfTu40E,^\4 uaf4T$If$IfLkd$$IfTu40E, ^\4 uaf4TH I w x X Z hV Fu$If^`uLkd_$$IfTu40E,^\4 uaf4T$If$If;kd$$IfTu4bE,,4 uaf4TZ " & X @B_kd$$IfTu4F E,@  \    4 uaf4T$If$If ^^$If^^` "$JLx|oi] 0F$If$If 08$If S@$If $If +@$If d$If d$IfLkd $$IfTu40E,^\4 uaf4T xzXbdf d$If d$If$If +d$If +$If $If$IfXdj"$,:<>DPRX(( ( ((( (&(((((((((((Z)^))**,+.+0+Z+^+`+b++++,,,,,,,,,,,,ŹŠhAzXjhAzXU hl5hlhlmH sH jhlUmH sH  hlCJhlCJmH sH  hlCJ hl5CJUhlCJ mH sH hlCJmH sH  hl5CJ=fhj"$,>DT$If $$Ifa$$If_kde $$IfTu4F$E,`^,0    4 uaf4TTVX (("(ysys$If $$Ifa$$Ifrkd* $$IfTu4\$-(E, ^,4 uaf4T l No l Is there a new drug submission for this drug under review in Canada? Yes l No l ADR Reports must be provided by the following deadlines: Fatal and Life Threatening Unexpected ADRs 1. Initial Report within 7 calendar days 2. Comprehensive Report within an additional 8 calendar days All Other Serious and Unexpected ADRs 1. Comprehensive Report within 15 calendar daysSignature: Date:   SEQ CHAPTER \h \r 1For Pharmaceutical Drugs: Please fax to: (613) 941-2121: For Biologics and Radiopharmaceuticals: Please fax to: (613) 957-0364     Adverse Drug Reaction (ADR) Expedited Reporting Summary Form (01-03) ________________________________________________________________________________________________ Adverse Drug Reaction (ADR) Expedited Reporting Summary Form (01-03) "($(&(((((((ysys$If $$Ifa$$Ifrkd= $$IfTu4\$-(E, ^,4 uaf4T(((\)^))**ypgZE RSd$If^S` _d$If d$If d$If d$If$IfrkdP $$IfTu4\$-(E, ^,4 uaf4T***.+0+F+H+Z+\+$IfNkdc$$IfTu4Y0E, ^`\4 uaf4T R@d$If d$If\+^+`+,,,,,,,,,,, ) D T $d41$akd)$$IfTu4F E,@   \    4 uaf4T ,,,,,8-:--....Q<Q ) D T $d41$ ) D T $d4d1$ ,,:--.... hlCJhAzXhlCJmH sH hlmH sH  hlCJhl3 0@PBP/ =!T"T#$T%e /Dd T  c 0A hc_bwb!H©{7n4OscDn[!H©{7n4OsPNG  IHDR#PLTE{{{333ŭRRRBBBsss(((fffJJJ:::!!!ZZZd$tRNSX, bKGDHgIFg>U cmPPJCmp0712HsIDATXGWr8 b1k@=&!i3Z2Gґ ~sO2t>{.|dnWˣ^+h>mZNGծшHpm MM@,~gqίpRf%.+c(cBez>FISܱ("<߯M>[X~?KR'Nko#)YN o8X*GHqcL<8ai6svyfDZ3b?qq0o@%Mj>Ko+E~N@_Еڒ֚P8lcyX#}#uUGǍDlf|# wkKimMwy60O~'2̐'ĜIZÀ,}']E/ jhha?sʡT#c&, (yEuz/5ӂD`OncGX#CY<ùQ_zHM58 jN[l7Q WfDUﷄ~QGrH[Q=]% r[^ЋkS>Ss;!Puj8z_f}^y'D/tIs0Y2UJWdJwt?9)*̢tHkqkӺ ɇ#VǣJBKE]^Z*.8Cl>AE=lc@j4^?hUW,^NMT|4hZ&%A> tڙ0e)&;N_汑>;i}/{I+MvJ#Kpb..h SQ7 o1uȇAMӕKIBqtUhw#kA(mU]F]pvY9A"3g8a1R~G(d 8Dzt ϹRaur'xKaU0BW]k~&eGe`| bUC_w< ƹ/|~/O>NiDjIENDB`$$If!vh5^5\#v^#v\:V u4+5^5\/ /  44 uf4T$$If!vh5^5\#v^#v\:V u4+5^5\/ /  44 uf4T$$If!vh5^5\#v^#v\:V u45^5\/ /  44 uf4Tz$$If!vh5,#v,:V u4b5,/ /  44 uf4T$$If!vh5^5\#v^#v\:V u45^5\/ /  44 uf4T$$If!vh5@ 5 5\#v@ #v #v\:V u45@ 5 5\/ /  /  / / /  44 uf4T$$If!vh5^5\#v^#v\:V u45^5\/ / /  44 uf4T$$If!vh5^5,50#v^#v,#v0:V u4+5^5,50/ /  / /  44 uf4T$$If!vh5^5,55#v^#v,#v:V u4+5^5,5/ / / / / / /  / / 44 uf4T$$If!vh5^5,55#v^#v,#v:V u4+5^5,5/ / / / / / /  / / 44 uf4T$$If!vh5^5,55#v^#v,#v:V u4+5^5,5/ / / / / / /  / / 44 uf4T$$If!vh5^5\#v^#v\:V u4Y++5^5\/ / / /  / 44 uf4T$$If!vh5@ 5 5\#v@ #v #v\:V u4+5@ 5 5\/ / / 44 uf4TR<@< NormalCJ_HmH sH tH DA@D Default Paragraph FontVi@V  Table Normal :V 44 la (k(No List HH [x Balloon TextCJOJQJ^JaJ6O6 Document[1]CJ$54O4 Document[2]5>*2O!2 Document[3]54O14 Document[4]56.OA. 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