ࡱ> z|yk Ebjbjz z 4HJbJb :R R 8.%d<! Y$[$[$[$[$[$[$$&)$i$$FY$Y$"#`-"E$$0.%",*r*#*#@A0q"AAA$$drAAA.%*AAAAAAAAAR B : Clinical Research Center (CRC) Amendment Submission Form General Information: All amendments except those dealing with recruitment materials need to be on record with the CRC. The current version of the protocol, consent form(s), and assent form(s) must always be on file with the CRC. Amendments submitted to a central or single IRB - The CRC does not have access to these amendments, so it is the study teams responsibility to submit the amendment and supporting documentation to the CRC. Amendments to RSRB-reviewed protocols that have not indicated in the Click IRB system that CRC resources would be used The CRC does not have access to these amendments, so it is the study teams responsibility to submit the amendment and supporting documentation to the CRC. Amendments to RSRB-reviewed protocols that have indicated in the Click IRB system that CRC resources would be used The CRC has access to the amendments and supporting documentation, but does not receive notification of amendment approval. It is the study teams responsibility to communicate to the CRC when an amendment has been approved. All amendments must be IRB-approved prior to implementation. Please complete the information below, provide supporting documentation, and send to  HYPERLINK "mailto:CTSI@urmc.rochester.edu" CTSI@urmc.rochester.edu or mail physical copies to Box 708. If you have any questions, please contact Karen Grabowski at  HYPERLINK "mailto:Karen_Grabowski@urmc.rochester.edu" Karen_Grabowski@urmc.rochester.edu. PI:  FORMTEXT       CRC #  FORMTEXT       Amendment: #  FORMTEXT       dated  FORMTEXT       Will this amendment impact the CRC?  FORMCHECKBOX  No, this amendment will not impact the CRC and is only for information purposes.  FORMCHECKBOX  Yes, this amendment will impact the CRC. Please indicate below the CRC cores impacted by the amendment and detail in the area provided what the CRC staff will need to know to change current practices with your protocol. (Please do not simply refer to a protocol page.)  FORMCHECKBOX  Bionutrition Impact:  FORMTEXT        FORMCHECKBOX  Nursing Impact:  FORMTEXT        FORMCHECKBOX  This amendment results in additional admissions/outpatient visits:  FORMCHECKBOX  Admissions: Number of Subjects:  FORMTEXT       Per Subject: Number of days per admission:  FORMTEXT       Per Subject: Number of admissions:  FORMTEXT        FORMCHECKBOX  Outpatient Visits: Number of Subjects:  FORMTEXT       Per Subject: Number of visits:  FORMTEXT       Per Subj9:M! " : Q R T  % 7 @ g h - . 4 ŻűŻϻ{pbXbMbh>*OJQJ^JhOJQJ^Jhh_>*OJQJ^Jhu>*OJQJ^Jhh_5>*OJQJ^Jh-tOJQJ^Jh_h_>*OJQJ^Jh_hq>*OJQJ^Jh6 OJQJ^Jh_OJQJ^JhqOJQJ^JhOJQJ^Jhh>*OJQJ^JhU|OJQJ^JhhU|5OJQJ^J9:O" e vx<>  h^hgdG.gd{gdOh^hgd & F ^gd_ & Fgd$a$4 8 J S {  a d | % & = > ? B G ^ õëë͡}pbbSbÊh^h-t0JOJQJ^Jjh-tOJQJU^Jh_hAFOJQJ^Jh_hG.OJQJ^Jh_hU|OJQJ^JhbyOJQJ^JhOJQJ^Jh6 OJQJ^Jh6 h-t5OJQJ^Jh-tOJQJ^Jh_OJQJ^Jhu>*OJQJ^Jhh_>*OJQJ^Jhh_5>*OJQJ^J^ a } ~   µš~q`OBhOhU|OJQJ^J hdhdCJOJQJ^JaJ hdhU|CJOJQJ^JaJh$BhU|OJQJ^Jhrh$B0JOJQJ^Jh$Bh$BOJQJ^Jjh$BOJQJU^JhhU|OJQJ^JhhOOJQJ^Jh$BOJQJ^Jh_hOOJQJ^Jh_hEpOJQJ^Jh_hU|OJQJ^Jh_hl5OJQJ^J   "$.08>JL`bdnpvx߅t^H*j\hOhU|>*OJQJU^J*jhOhU|>*OJQJU^J h uhU|CJOJQJ^JaJ*jthOhU|>*ϴO.ϴOUϴ'OU>*Ա*OU>*ϴOU>*ϴ$OU>*ϴ<>@\^`   ̻xhXN= h uhG.CJOJQJ^JaJh{OJQJ^Jh{hG.5>*OJQJ^JhdhG.5>*OJQJ^J'jh{hG.OJQJU^J!jh{hG.OJQJU^J hhG.CJOJQJ^JaJh{hG.OJQJ^J h uh{CJOJQJ^JaJhOhU|OJQJ^J'jhOhU|>*U^JmHnHu$jhOhU|>*OJQJU^J%37FGOQnou56789GHIkͰ͙ͦ~l^Il^)jhCJOJQJU^JaJhCJOJQJ^JaJ#jhCJOJQJU^JaJ h uhU|CJOJQJ^JaJhOJQJ^Jh{hOOJQJ^Jh{OJQJ^JhdhG.5>*OJQJ^Jh{h{OJQJ^Jh{hG.OJQJ^J!jh{hG.OJQJU^J'j8h{hG.OJQJU^J H67WDLbt444>5`gd ^`gd5|i ^`gd m h^`hgd5|ih^hgd m`gdt=h^hgdgdQH @^@`gd{gd{klvw  .02BDln祖pbOAhlCJOJQJ^JaJ$jh>*OJQJU^Jht=CJOJQJ^JaJ)jhCJOJQJU^JaJhCJOJQJ^JaJ#jhCJOJQJU^JaJh{OJQJ^JhCJOJQJ^JaJ)jh>*OJQJU^JmHnHu$jh>*OJQJU^Jh>*OJQJ^Jjh>*OJQJU^JHJLPRnprtֳ֥֓~m\mJ\#h5|ih m5CJOJQJ^JaJ h5|ih5|iCJOJQJ^JaJ h5|ih mCJOJQJ^JaJ)jh mCJOJQJU^JaJ#jh mCJOJQJU^JaJhCJOJQJ^JaJh mCJOJQJ^JaJ)jtht=CJOJQJU^JaJht=CJOJQJ^JaJ#jht=CJOJQJU^JaJht=OJQJ^J:<PRT׽~mVD*V2jh5|ih m>*CJOJQJU^JaJ#h5|ih m>*CJOJQJ^JaJ,jh5|ih m>*CJOJQJU^JaJ h5|ih mCJOJQJ^JaJ#h5|ih5|i5CJOJQJ^JaJ h5|ih5|iCJOJQJ^JaJ7jh5|ih5|i>*CJOJQJU^JaJmHnHu2j\h5|ih5|i>*CJOJQJU^JaJ#h5|ih5|i>*CJOJQJ^JaJ,jh5|ih5|i>*CJOJQJU^JaJT^`h̻oU9$)jh5|iht=CJOJQJU^JaJ7jh5|ih5|i>*CJOJQJU^JaJmHnHu2jHh5|ih5|i>*CJOJQJU^JaJ#h5|ih5|i>*CJOJQJ^JaJ,jh5|ih5|i>*CJOJQJU^JaJ h5|ih5|iCJOJQJ^JaJ#h5|ih5|i5CJOJQJ^JaJ h5|ih mCJOJQJ^JaJ,jh5|ih m>*CJOJQJU^JaJ7jh5|ih m>*CJOJQJU^JaJmHnHu "LNbdfprtﱚnR@/ h5|ih mCJOJQJ^JaJ#h5|ih5|i5CJOJQJ^JaJ7jh5|ih5|i>*CJOJQJU^JaJmHnHu2j2h5|ih5|i>*CJOJQJU^JaJ#h5|ih5|i>*CJOJQJ^JaJ,jh5|ih5|i>*CJOJQJU^JaJ h5|ih5|iCJOJQJ^JaJ)jh5|iht=CJOJQJU^JaJ/jh5|iht=CJOJQJU^JaJ h5|iht=CJOJQJ^JaJ4 4 4H4J4^4`4׽~|~kTB(2jh5|ih5|i>*CJOJQJU^JaJ#h5|ih5|i>*CJOJQJ^JaJ,jh5|ih5|i>*CJOJQJU^JaJ h5|ih5|iCJOJQJ^JaJU#h5|ih5|i5CJOJQJ^JaJ h5|ih mCJOJQJ^JaJ7jh5|iht=>*CJOJQJU^JaJmHnHu2jh5|iht=>*CJOJQJU^JaJ#h5|iht=>*CJOJQJ^JaJ,jh5|iht=>*CJOJQJU^JaJect: Approximate length of visit:  FORMTEXT       hours  FORMCHECKBOX  Re-open a previously closed study Impact:  FORMTEXT        FORMCHECKBOX  Other Impact:  FORMTEXT       Supporting Documentation must accompany all amendments. The following are included with this amendment:  FORMCHECKBOX  Revised Protocol: version/date  FORMTEXT        FORMCHECKBOX  IRB Certificate/Letter of Approval for the Amendment  FORMCHECKBOX  Revised consent`4b4l4n4p4|4~44444444445黪zhZEhZ7ZhQHCJOJQJ^JaJ)jhCJOJQJU^JaJhCJOJQJ^JaJ#jhCJOJQJU^JaJht=>*OJQJ^Jht=OJQJ^Jh mht=OJQJ^Jh mCJOJQJ^JaJ h5|ih mCJOJQJ^JaJ#h5|ih5|i>*CJOJQJ^JaJ7jh5|ih5|i>*CJOJQJU^JaJmHnHu,jh5|ih5|i>*CJOJQJU^JaJ55,5.505:5<5>5@5B5^5`5b555555祖p`UB`$j h u>*OJQJU^Jh u>*OJQJ^Jjh u>*OJQJU^J)j~ h uCJOJQJU^JaJh uCJOJQJ^JaJ#jh uCJOJQJU^JaJh{OJQJ^JhCJOJQJ^JaJ)jh>*OJQJU^JmHnHu$j h>*OJQJU^Jh>*OJQJ^Jjh>*OJQJU^J>5@5p555660770DDDDDDDDDDDEEEh^hgdgd u`gd u55555666666667 77 7"7,7.707иo`Io4o)jhU|>*CJU^JaJmHnHu,j hU|>*CJOJQJU^JaJhU|>*CJOJQJ^JaJ&jhU|>*CJOJQJU^JaJhCJOJQJ^JaJ)jh hU|CJOJQJU^JaJ#jhU|CJOJQJU^JaJhU|CJOJQJ^JaJh uOJQJ^JhU|OJQJ^Jjh u>*OJQJU^J)jh u>*OJQJU^JmHnHu0727N7P7R777777777778D.D0D2DNDPDRDdDfD߼߮ߜyߎwbN&jhU|>*CJOJQJU^JaJ)j hU|CJOJQJU^JaJU)j hCJOJQJU^JaJhCJOJQJ^JaJ#jhCJOJQJU^JaJhCJOJQJ^JaJhdCJOJQJ^JaJ)jD hU|CJOJQJU^JaJhU|CJOJQJ^JaJ#jhU|CJOJQJU^JaJ form(s)/assent form(s)  FORMCHECKBOX  Other:  FORMTEXT           Amendment Submission Form - Version 091421 fDzD|D~DDDDDDDDDDDDDDDDEEEŰŢzlhhqh/rCJOJQJ^JaJh"dCJOJQJ^JaJhqCJOJQJ^JaJhMWjhMWUhU|CJOJQJ^JaJ)jhU|>*CJU^JaJmHnHu&jhU|>*CJOJQJU^JaJ,j| hU|>*CJOJQJU^JaJhU|>*CJOJQJ^JaJ21h:pt=/ =!"#$% tDText2tDText3tDText5tDText6hDehDetDeCheck1vDText12tDeCheck1vDText12tDeCheck1tDeCheck1vDText12vDText12vDText12tDeCheck1vDText12vDText12vDText12tDeCheck1vDText12tDeCheck1vDText12hDetDText7hDehDehDevDText11s2 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@_HmH nH sH tH @`@ NormalCJ_HaJmH sH tH DA`D Default Paragraph FontRiR  Table Normal4 l4a (k (No List 44 Header  !4 4 Footer  !HH k Balloon TextCJOJQJ^JaJ6U`!6 _ Hyperlink >*B*phB' 1B Comment ReferenceCJaJ<B<  Comment TextCJaJ:Q: Comment Text Char@jAB@ Comment Subject5\F/qF Comment Subject Char5\PK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭Vc:E3v@P~Ds |w< H 999<4 ^ kT`45507fDE  # >5E %=%17JV\eqw 8Hkw} 0 U a g  * 0 R ^ d     ( K W ]    W g XXFFFFG$G$G$FG$FG$G$FFFG$FFFG$FG$FG$FG$G$G$F8@0(  B S  ? OLE_LINK1Text2Text3Text5Text6Text7Text11O&Kf 8]x !!!   =*urn:schemas-microsoft-com:office:smarttags PlaceType=*urn:schemas-microsoft-com:office:smarttags PlaceName9*urn:schemas-microsoft-com:office:smarttagsplace   3!""T7@JSaccee|?BG & & E V !""T7@JSaccee|?BG & & E V PFp0^`pCJOJQJo(hH^`OJQJ^Jo(hHopp^p`OJQJo(hH@ @ ^@ `OJQJo(hH^`OJQJ^Jo(hHo^`OJQJo(hH^`OJQJo(hH^`OJQJ^Jo(hHoPP^P`OJQJo(hHPFS        JIo/_Ls$6 n2 u/r(c^^"=(kh-G.w.0?1 F4l57t=$BEAFQHJ4O^U&#Xd5|i&iUj m(er-t uby3zX{U|.<k{Kh4`&3O04MW ,]3EpWFloq>"d }s# @yyyydxx x x x @ @46DUnknownG.[x Times New Roman5Symbol3. .[x Arial5. .[`)Tahoma?= .Cx Courier New;WingdingsA$BCambria Math"1h6b':b'f  4  3QIP ?2!xx3V Clinical Research Centernneedler Mary Little Oh+'0[ (4 T ` l xClinical Research Center nneedlerNormal Mary Little3Microsoft Office Word@^в@d{@$,@0    2 XF0    2 XN0  ---  2 XV0  - @ !(Z- - @ !(Z.-  - - -   2 i`0   --- @2 {`#0 Will this amendment impact the CRC?       2 {o0   - - -   2 `0   ------  0---  0 '- -pa-- '--- 2 r0   (2 0 No, this amendment   --- 2 0 will  2 60 not ---  2 O0   L2 S+0 impact the CRC and is only for information             2 0  - @ !8-  --- 2 x0   2  0 purposes.     2 0   - - -   2 x0   ---  0---  0 '- -pa-- '--- 2 r0   2 0 Yes, t   2 0 his amendment   --- 2 0 will ---  2 80    2 =0 impact the CRC     2 0 .  2 0  - @ !-  --- 2 `0   2 0   72 0 Please indicate below the CRC            2 e0   2 i0 cores    C2 %0 impacted by the amendment and detail            2 0 in   &2 0 the area provided        ^2 70 what the CRC staff will need to know to change current               M2 ,0 practices with your protocol. (Please do no               @2 #0 t simply refer to a protocol page.)            2 0   - - -   2 `0   @"Arial- - - ---  2 )`0  0  0- - -   0 '--*--'- - -   2 )0   2 ) 0 Bionutrition   2 )0   @"Arial---- - - - - -  2 ;x 0   2 ; 0 Impact:  ---  2 ;0    2 ;0    2 ;0    2 ;0    2 ;0  ---  2 ; 0  - @ !-=- ---  2 M`0   - - -   0  0 '--_Q--'- - -   2 ^0   2 ^0 Nursing   2 ^0   - - -  2 px 0   2 p 0 Impact:  ---  2 p0    2 p0    2 p0    2 p0    2 p0    2 p 0  - @ !-r- ---  2 x0   - - - ---  2 x0   2 0    0- - -   0 '----'- - -   2 0   22 0 This amendment results in    F2 k'0 additional admissions/outpatient visits   2 a0 :  2 e0   @"Arial---- - - ---- - -   2 x0    2 0  0  0  0 '----'- - -   2 0    2 0   2  0 Admission    2 0 s 2 %0 : ---  2 ,0  - - -  +2 00 Number of Subjects:     2 0    2 0    2 0    2 0    2 0    2 0  @ Arial---- @ !(- ---- - - --- 2  0 Per Subject:   - - -   2 F0   2 J0 Nu  72 \0 mber of days per admission:    2 0    2 %0    2 -0    2 50    2 =0    2 E0  - @ !(-  "Systemvd^/--  00//..?: ՜.+,D՜.+,X hp  University of Rochester  Clinical Research Center TitleH 8@ _PID_HLINKSA [ *mailto:Karen_Grabowski@urmc.rochester.edu:Amailto:CTSI@urmc.rochester.edu  !"#$&'()*+,./0123456789:;<=>?@ABDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnoprstuvwx{Root Entry FPW-}Data %1Table-*WordDocument4HSummaryInformation(C@[DocumentSummaryInformation8qCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q