ࡱ> _ Jbjbj @l9b9b G@ VVVjjj8ljJ>.X$=======$x@.C@=QVb"=>R8V==:$,>!%p "fR$ y=>0J>$RnDnD!%!%nDV5%D==J>nD B :   REPORT OF AN ADVERSE EVENT OR UNANTICIPATED PROBLEM for Human Subject Research Adverse events and unanticipated problems must be reported to the IRB as soon as they are identified. Adverse event or unanticipated problem defined: Adverse event: Adverse events encompass both physical and psychological harm. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. Unanticipated problem: Any incident, experience or outcome that meets all of the following criteria: Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents (such as the IRB-approved research protocol and informed consent document), and the characteristics of the subject population being studied; Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. 1. ProtocolTitle: FORMTEXT      IRB Number:  FORMTEXT      Today s Date:  FORMTEXT      Principal Investigator:  FORMTEXT      E-mail:  FORMTEXT      Other person to correspond with regarding this report:  FORMTEXT      E-mail:  FORMTEXT       FORMCHECKBOX  I am a student. If a student, please provide information about your faculty sponsor below.Name:  FORMTEXT      E-mail:  FORMTEXT      2. Event/Problem ReportingDate event/problem occurred:  FORMTEXT      Date event/problem was identified:  FORMTEXT      Location of event/problem:  FORMTEXT      Please describe event/problem: FORMTEXT      Has this happened previously?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If  yes, please describe: FORMTEXT      Does this involve a breach of confidentiality?  FORMCHECKBOX  Yes  FORMCHECKBOX  No3. Analysis/Plan of ActionDo you think this changes the risk benefit ratio of the study?  FORMCHECKBOX  Yes  FORMCHECKBOX  No9:;<UVW # | ŵҨwgWHWH8Hh\2h<5CJOJQJaJh\2h<CJOJQJaJh\2h<6CJOJQJaJh\2h<>*CJOJQJaJh6 KOJQJh<OJQJh">OJQJhR^5OJQJh9lXhR^5CJOJQJaJhR^5CJOJQJaJhR^hR^5CJOJQJaJh">5CJOJQJaJhj(5CJOJQJaJ-jhj(5CJOJQJUaJmHnHuh*YE5OJQJV ? W >  $$Ifa$gdqH$a$gdqH $ & Fa$gd\2 $ & Fa$gd<$a$gd<$a$gdj(gdR^| V W 9 =       񴨟u`H`6`"jh,G5CJOJQJUaJ.j hqHh\25CJOJQJUaJ(jhqHh\25CJOJQJUaJhqHh\2CJOJQJaJhqHh\2OJQJhqHh\25CJOJQJaJhqH6OJQJhqHCJOJQJaJh\2CJOJQJaJ"hTM!h\25>*䴳ϴ226Cϴ2<CJOJQJaJh\2h\2CJOJQJaJ  { $$Ifa$gdqHwkd$$Ifl**  t 0644 lap ytqH #hkd}$$Ifl** t0644 laytqH $$Ifa$gd,Ghkd$$Ifl** t0644 laytqH *,@BDNPpr їїgїO.jhqHh\25CJOJQJUaJ.j]hqHh\25CJOJQJUaJ.jfhqHh\25CJOJQJUaJ"jh,G5CJOJQJUaJ.jhqHh\25CJOJQJUaJhqHh\25CJOJQJaJ(jhqHh\25CJOJQJUaJhqHh\2OJQJhqHh\2CJOJQJaJR.x{kd$$Ifl0H*B t0644 laytqH $$Ifa$gd,G *,.0"$&Jʿٯٯʿl]Gl]+j3hqHh6 KCJOJQJUaJhqHh6 KCJOJQJaJ%jhqHh6 KCJOJQJUaJ.j<hqHh\25CJOJQJUaJ.jhqHh\25CJOJQJUaJhqHh\25CJOJQJaJhqHh\2OJQJhqHh\2CJOJQJaJ(jhqHh\25CJOJQJUaJ"jh,G5CJOJQJUaJ.0xx $$Ifa$gd,G{kdE$$Ifl0H*B t0644 laytqHx $$Ifa$gdqH{kd$$Ifl0H*B t0644 laytqHJ *,@BDNPRT~oW~oLhqHh\2OJQJ.jhqHh6 K5CJOJQJUaJhqHh\2CJOJQJaJ3jhqHh6 K5CJOJQJUaJmHnHu.jhqHh6 K5CJOJQJUaJhqHh6 K5CJOJQJaJ(jhqHh6 K5CJOJQJUaJhqHh6 KCJOJQJaJhqHh6 KOJQJhqHh6 K6CJOJQJaJR $$Ifa$gdqHhkd$$Ifl** t0644 laytqHRTx $$Ifa$gdqH{kd$$Ifl0H*B t0644 laytqHb{{ $$Ifa$gdqHwkd$$Ifl**  t 0644 lap ytqH:<PRT^`bdӹӪӚӹӪwӚ_ӹӪwwӚG.j hqHh6 K5CJOJQJUaJ.j hqHh6 K5CJOJQJUaJhqHh6 KOJQJ.j hqHh6 K5CJOJQJUaJhqHh6 K5CJOJQJaJhqHh6 KCJOJQJaJ3jhqHh6 K5CJOJQJUaJmHnHu(jhqHh6 K5CJOJQJUaJ.j hqHh6 K5CJOJQJUaJbdx $$Ifa$gdqH{kd $$Ifl0* t0644 laytqH#hkdo $$Ifl** t0644 laytqH $$Ifa$gdqHhkd $$Ifl** t0644 laytqH *,.0np&(*,·¤Ž¤x·hP·¤.jThqHh6 K5CJOJQJUaJhqHh6 K5CJOJQJaJ+j] hqHh6 KCJOJQJUaJ+j hqHh6 KCJOJQJUaJ%jhqHh6 KCJOJQJUaJhqHh6 KOJQJhqHh6 KCJOJQJaJ3jhqHh6 K5CJOJQJUaJmHnHu(jhqHh6 K5CJOJQJUaJ.0hkdf $$Ifl** t0644 laytqH $$Ifa$gdqH*,#hkd$$Ifl** t0644 laytqH $$Ifa$gdqHhkd $$Ifl** t0644 laytqH$&DDDDDDDDDZǦLJucaǦLJO#jhqHh6 KOJQJUU#jhqHh6 KOJQJU#j<hqHh6 KOJQJUjhqHh6 KOJQJUhqHh6 K5CJOJQJaJhqHh6 KOJQJ+jhqHh6 KCJOJQJUaJhqHh6 KCJOJQJaJ%jhqHh6 KCJOJQJUaJ+jKhqHh6 KCJOJQJUaJ,$hkd3$$Ifl** t0644 laytqH $$Ifa$gdqH$&D{ $$Ifa$gdqHwkd$$Ifl**  t 0644 lap ytqHDo you think the protocol or informed consent need to be modified in light of this incident?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Please explain: FORMTEXT       What actions have you taken in response to this event/problem? FORMTEXT      What actions, if any, do you think are appropriate to prevent this from occurring again? FORMTEXT       FORMTEXT       FORMTEXT      Principal Investigator Name and SignatureDate NOTE: If this form is e-mailed from the Principal Investigator s Davidson e-mail account, a hand written signature is not needed. Please type in name and date and e-mail to HYPERLINK "mailto:hsirb@davidson.edu?subject=Adverse%20Event"hsirb@davidson.edu as an attachment.       PAGE \* MERGEFORMAT 1 Rev. 1/21/2019 For IRB Office Use IRB No.: _______ Rec d.: _______ DDEE@ETEVEXEbEdEfEhEnEEEEnj[P;(jhqHhqH5CJOJQJUaJhqHhqHOJQJhqHhqHCJOJQJaJhqH3jhqHh6 K5CJOJQJUaJmHnHu.jhqHh6 K5CJOJQJUaJhqHh6 K5CJOJQJaJ(jhqHh6 K5CJOJQJUaJhqHh6 KCJOJQJaJ#j hqHh6 KOJQJUjhqHh6 KOJQJUhqHh6 KOJQJEfEhE#hkdx$$Ifl** t0644 laytqH $$Ifa$gdqHhkd$$Ifl** t0644 laytqHhEjEnEEEFrrkd$$Ifl** t 6P0644 laytqH$$&P#$/Ifa$gdqH$a$gdqHEFFFFFFFFFFFFFFFFFFFFGG¨™v¨™aQ9.jh,Gh,G5CJOJQJUaJh,Gh,G5CJOJQJaJ(jh,Gh,G5CJOJQJUaJ.j4hqHhqH5CJOJQJUaJhqHhqHOJQJhqHhqHCJOJQJaJ3jhqHhqH5CJOJQJUaJmHnHu(jhqHhqH5CJOJQJUaJ.jhqHhqH5CJOJQJUaJhqHhqH5CJOJQJaJFFFz$$&P#$/Ifa$gdqHrkd$$Ifl** t 6P0644 laytqHFFFz$$&P#$/Ifa$gdqHrkd$$Ifl** t 6P0644 laytqHFFFz$$&P#$/Ifa$gdqHrkd$$Ifl** t 6P0644 laytqHFF"GJGzz$$&P#$/Ifa$gdqHrkd?$$Ifl** t 6P0644 laytqHGGG G"G$G8G:GJ@Jq`Kq(jhqHhqHCJOJQJUaJ*!hTM!CJOJQJaJmHnHuhqHhqHCJOJQJaJ%jhqHhqHCJOJQJUaJhqH jhIoShqHUmHnHuhTM!hF/jhF/Uh,G5OJQJh6OJQJhUFhl^80J6OJQJ jhl^86OJQJUhl^86OJQJjhl^86OJQJUIIIIIIJJJJ^J`JbJdJfJhJjJlJJJJJJJJJ$a$gdj($a$$ H$#a$gdqHgd9lX@J\J^JbJdJfJhJlJJJJJJJJJʺʺʶ٭h,G5OJQJhj(h*YEhj(>*CJOJQJaJh*YEhj(CJOJQJaJhF/hTM!hqHhqHhqHCJOJQJaJhTM!CJOJQJaJJJ$a$gdqH>PP&P1h:pqH/ =!"#$% $$If!vh#v*:V l  t 065*p ytqHs$$If!vh#v*:V l t065*ytqHtDText1s$$If!vh#v*:V l t065*ytqHtDText1tDText1$$If!vh#v#vB:V l t0655BytqHtDText1tDText1$$If!vh#v#vB:V l t0655BytqHtDText1tDText1$$If!vh#v#vB:V l t0655BytqHtDeCheck1s$$If!vh#v*:V l t065*ytqHtDText1tDText1$$If!vh#v#vB:V l t0655BytqH$$If!vh#v*:V l  t 065*p ytqHtDText1tDText1$$If!vh#v#v:V l t0655ytqHtDText1s$$If!vh#v*:V l t065*ytqH$$If!vh#v*:V l t065*/ ytqHtDText1$$If!vh#v*:V l t065*/ ytqHtDeCheck1tDeCheck1$$If!vh#v*:V l t065*/ ytqHtDText1$$If!vh#v*:V l t065*/ ytqHtDeCheck1tDeCheck1s$$If!vh#v*:V l t065*ytqH$$If!vh#v*:V l  t 065*p ytqHtDeCheck1tDeCheck1s$$If!vh#v*:V l t065*ytqHtDeCheck1tDeCheck1$$If!vh#v*:V l t065*/ ytqHtDText1$$If!vh#v*:V l t065*/ ytqH$$If!vh#v*:V l t 6P065*/ ytqHtDText1$$If!vh#v*:V l t 6P065*/ ytqH$$If!vh#v*:V l t 6P065*/ ytqHtDText1$$If!vh#v*:V l t 6P065*/ ytqH$$If!vh#v*:V l t 6P065*ytqHtDText1tDText1$$If!vh#v#v:V l t 6P0655ytqH$$If!vh#v#v:V l t 6P0655ytqHDyK yK |mailto:hsirb@davidson.edu?subject=Adverse%20EventyX;H,]ą'cDd  vA?DavidsonPicture 0Davidson.bmpb셧xyj"n셧xyjPNG  IHDRs ;sBIT3 sRGB}IDAThC͚_hw'E80_!"H! )L I*C>&>ɱB:ɰV+j6<3ag{,A&ɟ3]dBso>vbDqfwݻL]{f9ӥ +i`)dwOApx7Q(<߳̂GT@,/*ͼ< 6ε!*+/\M,B0KUĢ3ԯϽ1Cd9++i?[RlqYd~g1$-Fv/*‡%ms㫍/jfw;|Us>]>BGxPbx ,+QHĝUб(sA/ΈoSc T5^M0%:|+"=BYD]c5ۭm''({A1 eD,=P<]T].,+T>T l(bbj82-rbtL>/0ʒxOĶ^YY^a!-pPddkvĊ K9t^3 '~jYJ7$TudJli.J0Z|{6ZMjyqvF"MJH@8QgPE슺x~Eq@ %Q#IVd}}S>and [KgKW*1hҽ7LInA@dD^li4SWHzW_,G j|)M'\W53FsC&>.10Y,",gU7>ժy\IjW0Y* 2( 0dY2{"rm"k/gN4Ea7R1 i^\P!Φqe˚Y2k i\˟,ivAGӦ2HӨ֋ oe8;Z0{yoUYѴ=O0A6 eVX+EPCHNT]:Q8%Y .KDA`,Te->a[iVAu=I5r>ʁi/O]Ƌ_C z62xe=B2Ғ9.ET@śd o잰s 䱾ُT1;g@Lo|L=/E<˼E8ȶ;FYf7W 7u@ "h"㔽 wBܾݎATu_!_e#QD* p94~[G.㳃NQյgEr$KŚf*uֿ^GyJξZnGXf׉v? 'Uv$k5AzV)iS,^D5=4ƭ1-W>n5ĎlZ0ʷ%'˞JDj*"eڲ;H2d٠ϒU^4N$(*N( ǝDL$t(AIfz@>e)t`/xf\6Jz jm/K[(P?3>|ϭ)߸q<*IR`|lJE]HȋмnExO$MwpBNܻ3%-59Fx0e_i*U ORjr-.k_Pڷ<y2mSq-9}h|V%7LPe[F?aFc3J#t5.`ǖ=X@#`ԀB hP[Y]|O1.o">H9 ?J'f,.ȚYڃQIi v*Iyu9%xd̓u p0}M!_הU-.2lwv.M͍ ;"č@ǵUgTBjCqjv۟G۷w0ˈ@'O$ߌ曷aWuN18NGh"̩Mq?dy f+7i2S/֠>0/ۖ݅$NX9yj#C,i|a0}x71JUx̜"3 ,5W8;*ʉ̳S3^4Z泵uMqg^n/8#I%E gQD,gē|:A7 8o$'$RSՙuD~Cw$!_Zwm燕 yU0cx눂 =Y0U8\j|D'IGrVgLDR|\{ָREh]2I$VPHk4DZjEnƭrIk)cp~wGemew{An:]f9{nrFs]‹?JO-fκyW q`$[yV|ud%EÊuh4e=D0~b1HMW{{9ŮYɑN6#LD82ezpnsX!đѮDi)"tDAzpQ>g3YNFh;4(Љx!Z?hzH!d*Ohm@E`I2l;B>v7~qޮ|t8 Ȥ\(C'ی볅+Nۅv'K( ښ[ez(?iD_S  ~Z VGZuQ_&DG7_7;> 2&4HB05/R52#dFFGJ+ev(눷RoxKKӉY\ؐ)NQw;hC&T1#9seݣP3cq$dPFطRە(BL^8_'$/1> 9lX Header CharCJOJQJaJ4 @B4 9lX0Footer  H$>/Q> 9lX0 Footer CharCJOJQJaJDbD *YE List Paragraph ^m$HrH *YE Balloon TextCJOJQJ^JaJN/N *YEBalloon Text CharCJOJQJ^JaJ6U`6 R^ Hyperlink >*B*phFV F l^8FollowedHyperlink >*B*phPK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vc:E3v@P~Ds |w< ? ?B l BDFI|  JDEGI@JJ '*/24 .Rb,$D# -HN mm } A Z ] ]| !!(/!61!=!p?!TM!P!S!W![![! "_"v"#""t#"." 3"\4"G"aI"P"["]w"|"M#/#?7#?#Zh#<,$<$Tc$%F%B%*Q%b%:x%&,&;&Q&C~&'x''8'LF'IH'RX';x'((8(j(0t(z( )))))O)EV),v)T* *(*3*hE*++++3 +Q&+a9+P+`+Xd+k+ m+/p+,J,T ,1,',,+$,Y?,EF,G,O,X,Z, c, n,5-7-9-?-iE-EG-M-RR-3_-fz-}-.-6.>. F.I.$L.ET.T.i.8F/F/P/Yb/z/0j00$0?1080Oc0M(1c12_2*222x:2:H2L2Z2g3&363l3"(4S64\<4O4t45= 5-5[#6C6]6f6s67*67V7l7|s7)w78$8 8s8 ,8-8;8bT8l^89~8W(9F59<9@9gH9M9y9x.:>:L:s:>{:W ;a4;?;H;P;W;'\;r;$<,<< =0=i>=m=u>">T3>T>A?[?hb?@@8@;E@L@Y@i@bn@O|@@ A5AhDAU[A B)B3B KBdBinB&CG"C^(CtNChvCB!D%DYDDVuDE'E~AE*YEEFKFA"F'+F:F=FPFEGG&G-GjGGVGjoGH 1H2HDHqHII{NIcIJGJ{/JUJhJ6 K`K'KLKfKiKU{K L%L"LcLKhLlnLsqLowLMPIM3bMxM~M{/N\N oNO0Ot0OVO;XOgOPyBPCPQ;/QAQEQLQOQ\Q]QdQ<RRRRRR#RV)RcRmRnRA1Sd@SlbS|ST#Ty+T3T8TOTFVT U U7OU3gU V)V\VydVqVxVzVmWW0W$9WX2?XGX?RX9lXYjY"YMYkYDZ!Z,Z6ZFZueZ{Z[,[7[8[DH[b[Hh[g~[d\4\}\^]]4(]1*]*]t] ^^<^#^g4^6^I^R^l^.l^Pw^ _g _G_p_`H`"`Dakab b6b2Vb^bebsbb{bc-c2c}DcVc`c?{c[Fd^d&jdqdsd,yd es.e>ede>te^}e,f*f-f5f7frf\yfzfxgkg?ga2gAg4rg tgMtghbh hHhOhYhghiuiEOizij9@jFkkkQ;keky ll#lKlLlbl2dlQm-Um2lmpmmnxnRn1n:nFn#HnOnhnZ{nb$o,oy6o`ofoUgoropUpDsp{p#qqEqqq)qGq]qfqXqqqq2vq\2rzr$s:s\OsSsxst t(t[;tCtttuu`~g~m~GM22gltvxW@*=\d+,.+N-RUWp2(*@NQvZG P5dP)41_QWj?y5MpUZM\+ f~q.V77:kCq[>DLMnLQ c'VDL+4L=">TAsy\%3>qAVX ac8L=RUY]cgXh/" 4hIJ\y(% W/6xk7DSa7s,8>? KeoxS-jBWYbFccXws$[5j>. AQSAn  *+5q;T=Ul#=97;FM"1\g]g\[Y}>hXuyu D q~~#$%JJ?/b=IK8ST ^W2"7W[!ikyR\*`w5cz}1'JRkpm*/DtOhi{|'G}Zh` }:Xf-Tdn&o&)67k:+?X~ (PE]_MG~Oy$-W0LV*!9cZisWZW=J5TTf %_myf f#@CMDti HG\acfhi7z~(a^:k[?bP$^c{nA=EF/S#~iH"46vRq"2#).%/68B7qr+#`FjZ'ADEJR2x,?OUrV'j88;^WXa;jjj #8I|~ X#l/6>_I\`bd|a =xL,UVGeUg fy|z[4Nk{"#(E4i<=U\o p  >0J2\] ^hbzc '<,2Vo;sC!hYZA*8WkgpV~R_q| -TQq <W]s? n'E+2vx![/60Zd_Y$+7Plwzl&3oB\ -PKL\pa:dk}1,8ILI[ B Dt ;uF*J5gMnk/CR[\R99?Hotze 0uB )U,={JNe4B$T_|j)(9f$}z "18B1F{g nz%DDKXgj7W:yh-D?B4t|=HUe # 5qWw9WqX.P4d8a;;RWW g 7'C0Kp$HPT{mZ%^aq c8!(*ZWq{|Idff~ YFfrMlzxB6 M4U5R!^,GHYOI=I_p>.3IFa l5NN RIklJz|'dDH=^Eh  pB]pau]F[8]:{B`qyd:UY 3g Dd-z su#1aVdrGx<1Dq/r .Q1,E7ec 5Ma%<<PS2sk%.63lfknncpxzF|(K448L[lp?GDgVj1/ @L @DUnknown G*Ax Times New Roman5Symbol3. *Cx Arial7.@CalibriK@Palatino Linotype5. .[`)Tahoma?= *Cx Courier New;WingdingsA$BCambria Math"1hUq'Uq'= = qx0  B  2QHP?9lX*!xxX #Adverse Event Form-Davidson CollegeGAdverse Event Form, Davidson College, Davidson, form, unexpected eventsDavidson CollegeWinecoff, Beverly  Oh+'04H dp   $Adverse Event Form-СƵСƵHAdverse Event Form, СƵ, СƵ, form, unexpected events Normal.dotmWinecoff, Beverly2Microsoft Office Word@@NU@NU= ՜.+,D՜.+,` hp  СƵ.  $Adverse Event Form-СƵ Title 8@ _PID_HLINKSA<SK2mailto:hsirb@davidson.edu?subject=Adverse%20Event  !"#$%&'()*+,-./012345689:;<=>?@ABCDEFGHIJKLMNPQRSTUVWXYZ[\]^_`abcdefghijklmnopqstuvwxy{|}~Root Entry F"Data 7.1TableODWordDocument@lSummaryInformation(rDocumentSummaryInformation8zCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q