ࡱ>  %bjbj$$ F|F|00========8+>>=~r?:?4@@@BEFpÁŁŁŁŁŁŁŁ=XKBB"XKXKŁ==@@ځ\8N8N8NXK=@=@Á8NXKÁ8N8Njz@[i`p=RL"|26H~|*tLTd=/GG8NHtH[/G/G/GŁŁMp/G/G/G~XKXKXKXK/G/G/G/G/G/G/G/G/G0 <:  Monitoring Plan Table Of Contents  TOC \t "Subtitle,2,Chapter Title,1" Locations 3 Trial Management 4 Case Report Forms & Source Data 5 Quality Assurance & Quality Control 5 Safety Monitoring 7 Monitoring Activities 8 Study Completion 8  Locations {Specify Hospital location in which study will be conducted at} Massachusetts General Hospital 55 Fruit Street Boston, MA 02114-2622 Brigham and Womens Hospital 75 Francis Street Boston, MA 02115 Section Trial Management1 Purpose {Explain Purpose of Monitoring Plan, for example:} The purpose of this Monitoring Plan is to describe the rationale and process for the collection, recording, and verification of data for the {Trial Name} Objectives {Specify objectives, for example:} To establish a monitoring plan to ensure the data is in compliance with Good Clinical Practice (GCP), Partners Institutional Review Board (IRB) policies, and Federal regulations. To standardize the clinical data monitoring To ensure the validity, accuracy and integrity of the data Study Staff Responsibilities and Training {Record any protocol specific training or delegated responsibilities requiring special licensure} CITI Training The investigators and all staff involved in the study will have completed their required Collaborative IRB Training Initiative (CITI). Protocol Procedure Training Study staff delegated to conduct specific study procedures will be trained on these procedures individually or in a group format. Delegation of responsibility will be documented on the  HYPERLINK "http://www.partners.org/phsqi/QIWeb/logs/Site%20Signature%20and%20Delegation%20Log2.dot" Study Staff Signature and Delegation of Responsibility Log. SectionCRFs and Source Data2 Source Documentation and Case Report Forms {Indicate who is responsible for data collection and how often he/she will review the data for accuracy and completion} IRB Documentation {Indicate who is responsible for maintaining IRB Correspondence. Specify which IRB approved documents will be maintained as part of the study} SectionQuality Assurance & Quality Control3 Study Files {Indicate who is responsible for monitoring the study files. Specify how often this individual will monitor the files in order to ensure the appropriate regulatory and IRB documentations are on file and up to date.} {Specify what aspect of the study files will be monitored. For example:} Partners Human Research Committee (IRB): All IRB Correspondence is on file The study staff are IRB approved prior to performing any study procedures Adverse events and deviations are reported to IRB per current guidelines All versions of the IRB protocols and informed consent forms are on file FDA Signed 1571 and 1572 on file (note: Sponsors of device studies must obtain a signed agreement containing information similar to that requested on the 1572) All FDA correspondence (amendments, safety reports, annual review, associated 1571 and 1572) is on file Documentation of serious adverse events that are unexpected and related are reported to FDA within 7 calendar days Annual Report is on file and completed in a timely fashion Other documents: CVs for all study staff are on file and updated every 2 years Medical licenses for the Co-Investigators are on file and updated prior to expiration Delegation Log is updated as new staff are added or removed from the study or new procedures are added Financial disclosures for PIs and those listed on the 1572 are on file All other essential documents have been prepared and completed as appropriate Study Documentation {Indicate who will be responsible for ensuring proper study documentation in order to verify compliance with IRB, FDA and Good Clinical Practice (GCP) guidelines in the following areas: Informed Consent - In situations for which written consent is obtained: Ensure that subject identification is on all pages of the ICF There is documentation that the subject is given a copy of the consent form Clinic note documenting informed consent process The subject and study representative signed and dated the consent form for him/herself. The subject initialed and dated all appropriate pages on the informed consent form. Note to file made for any informed consent deviations. Ensure a valid (current version date) copy of the consent form was used Protocol: Confirm that the study staff is conducting the study in compliance with the protocol approved by IRB and if applicable, FDA. The protocol deviations (exceptions and violations) are documented in the subject chart and reported to IRB as required. Source Documents: Review subject charts to ensure that accuracy, completeness and legibility of the data Any correction made to the source documents is dated, initialed, and explained. The original entry should not be obscured. The protocol specific source documents are on file. Source documents are completed in ink Note to files are made for missing or incomplete data and to explain any discrepancies or additional comments. Electronic Case Report Forms (eCRF) if applicable: Ensure the data reported on the eCRF is consistent with the source documents. Discrepancies between the source documents and eCRF are explained in a note to file or captured in a comment in the eCRF. Query Management (If Applicable) {Specify, if there is an outside monitoring group (e.g. sponsors monitor, CRO) who is responsible for ensuring data accuracy and integrity. Indicate how data queries will be generated, processed, and responded to by the site.} Specify what may be queried, for example: Non-compliance to protocol Missing data Out-of-range data Out-of-window visits Data inconsistent with the source documents Data clarification Section Safety Monitoring4 Adverse Event Procedures {Indicate the process for identifying, recording and reporting adverse events (per sponsor, IRB, and FDA reporting guidelines.} Specific Roles for Adverse Event Recording and Monitoring {Indicate each staff members role in the adverse event reporting process} The research coordinator will complete the  HYPERLINK "http://www.partners.org/phsqi/QIWeb/logs/AETrackingLog.xls" AE Tracking Log; assist the PI to notify the IRB, FDA, DSMB of all SAEs, and assist them to prepare SAE reports to IRB, FDA, and/or DSMB. The Project Manager and Principal Investigator will confirm that all AEs are correctly entered into the AE log by the coordinator; be available to answer any questions that the coordinators may have concerning AEs; notify the IRB, FDA and/or DSMB of all SAEs and AEs as appropriate; The Monitor will confirm that the AEs are correctly entered into the Adverse Event log. The Monitor will confirm that the adverse events are consistent with the source documents and are reported to the appropriate regulatory bodies, as required. SectionMonitoring Activities5{Summarize monitoring activities: Who will conduct the monitoring, what will be monitored, frequency of monitoring, and how will findings/observations be documented}. {Consider adding a flow chart to further illustrate the process} SectionStudy Completion6 {Specify how study close-out process will occur (e.g maintenance of study files and data retention}     PAGE  PAGE 8  Partners Human Research Quality Improvement Program  HYPERLINK "http://www.partners.org/phsqi" www.partners.org/phsqi Monitoring Plan Template, version date: November 2008 +,/0UV_`abrstuľnncnnnXh+*P^JmHnHuhKn^JmHnHu'h5;@OJQJmHnHtH uhKnmHnHuhmHnHuh]h^JmHnHujh^ U^Jh^ OJQJ^Jh^ CJT^J h^ ^Jhsh^ 5CJ$^JaJ$h^ OJQJ^JmH sH hJOJQJ^Jhg`OJQJ^Jhg`5CJ$^JaJ$"*+,ga$Ifckd$$If40+&3 af4p$If$If $d0N0$$d0N0a$gdg` $^a$gdg` ,-./bu    - X%, %^Xkd$$If40+&3   af4p $If      # > A b c ٸwpj`j`jSISEƀ <˦^`>gdV & F >Eƀ <˦^`>gdh^hgdpF: @   7 8 9 : H V c d k + 4 N wpfXLCLh0@CJ\h7h'@CJ\hPh^ 5mHnHuhPh'5\ h05\#h;fh;f5B*CJ\aJph#h;fh'5B*CJ\aJphh;5B*CJ\aJphhPh^ 5KH\mH sH  hBh5^JhPh,N5^JhPh^ 5^Jh^ OJQJ^JhmHnHu h.^J h `7^J h^J h0^J 7 8 9 d c d oob dh^`$d^`a$gd0dh^ dh^gd; hdh^V & F >Eƀ <˦^`>gd N ` a b c d 9:»yuqke[QeQeGh'h^ 5^Jh^ OJQJ^JhKnOJQJ^J h^ ^J h;f^Jh^ hJha(hi/CJ\h6h60JCJ\"jh6h%9CJU\jh6CJU\ h6CJ\ hi/CJ\ hUFCJ\hUFhZ6CJ\aJhh;f6CJ \aJ h0@CJ\h7h^ @CJ\h7h@CJ\ rlf$If$Ifakd$$If40% ! %af4p $$Ifa$$Ifdh^$d^`a$gd[w0PQY} $$Ifa$$If ^VkdW$$If40%  !  %af4p  /0DHNOPQXY|}~ɿ븮}s}}l[ h h&@B*CJ\ph h4hJ5^JhOJQJ^J h^ ^J h&^Jh&h `7B*phh&h&B*phh^ h'h^ 5\h'h)(5^J h[5^Jh^ OJQJ^J h^ \ h;faJh&B*aJphh;fh;fB*aJphh'h^ 5^Jh'h f5^J}~64Xkd$$If40O& !  W&af4p $If$Ifckd$$If40O&! W&af4pmnMGO$ & FdEƀ <˦a$gd4hJO$ & FdEƀ <˦a$gd4hJ$d^`a$gd'gd4hJ7<?MNRjklmnpMͼͫzlczZzQzQHQHho@CJ\h}@CJ\h@CJ\h=D@CJ\hh}5@CJ\h4hJ@CJ\ h h4hJ@B*CJ\phh @B*CJ\phh @CJ\ h hyV@B*CJ\ph h hX:@B*CJ\ph h hjB@B*CJ\ph h h}@B*CJ\ph h h @B*CJ\phM_QQ;$ d^`a$gdo$ da$gdoO$ & FdEƀ <˦a$gd4hJO$ & FdEƀ <˦a$gd4hJ^k+>f;<=>?@DRԹ԰~rkaZSZ h.sO5^J h5^Jh^ OJQJ^J h^ 5\hYh^ @CJ\h98hY@CJ\h @CJ\h98ho5@CJ\h98h985@CJ\h98@CJ\hx4@CJ\h=D@CJ\h@CJ\ho@CJ\hyV5@CJ\hoho5@CJ\hyV@CJ\_O$ & FdEƀ <˦a$gdoO$ & FdEƀ <˦a$gdo^_II$ d^`a$gd98O$ & FdEƀ <˦a$gd98O$ & FdEƀ <˦a$gdo?_O$ & FdEƀ <˦a$gd98O$ & FdEƀ <˦a$gd98?_O$ & FdEƀ <˦a$gd98O$ & FdEƀ <˦a$gd98;=>?S WXyyff$d^`a$gd?)$d^`a$gdpF`gd5x$  d^ `a$gdYO$ & FdEƀMFa$gd98 RS  !TUVX BC±¨|sjsasjsXOXH h^ 5>*h{80@CJ\h @CJ\hx4@CJ\hu@CJ\ho@CJ\h `75@CJ\h85@CJ\h?)5@CJ\h:A5@CJ\h:A@CJ\ hch @B*CJ\ph hch:A@B*CJ\ph hch@B*CJ\ph hchc@B*CJ\phhYh^ 5^JXMO$ & FdEƀ <˦a$gd:AO$ & FdEƀMFa$gd:A$ & F da$gd?)l_O$ & FdEƀ <˦ a$gd:AO$ & FdEƀ <˦a$gd:ABCM_YF8$ & Fda$gdo$d^`a$gdo^O$ & FdEƀ <˦ a$gd:AO$ & FdEƀ <˦ a$gd:ACKM6BDEFVX*8_`+-{|úñ}t}i^PGhLn;@CJ\h}hP55@CJ\hc5@CJ\hP55@CJ\hJw\@CJ\h3@CJ\hP5@CJ\ha@CJ\h}hw5@CJ\hw5@CJ\hw@CJ\h?)@CJ\h `7@CJ\h@V@CJ\ho@CJ\h/:@CJ\h}ho5@CJ\h/:5@CJ\DFX+`-|$ da$gdw$ & Fda$gdP5$d^`a$gdP5$ da$gdP5$d^`a$gdw$ 8d^8`a$gd?)$ & Fda$gdw| )JOPV` $,-.cgh~~sk`\X\hq1h(ohhB*phh(oB*phhhCB*phhhaB*phhB*phhB*phhhf&&B*phhhcB*ph h5^Jhaha5^Jhah^ 5^J h5x5^Jh^ OJQJ^Jhw@CJ\hP5@CJ\hJw\@CJ\hLn;@CJ\"-.IV`I & FEƀ <˦gd(oI & FEƀ <˦gd(o^gdpFVh}k!I & FEƀ <˦gd(oI & FEƀ <˦gd(oI & FEƀ <˦gd(oh}z{|   »̻paQK h{>CJh7h75B*CJ\phhpFh{>B*CJ\phhpFh7B*CJ\phh{>hm5^J hph@5^JhCh^ B*PJphhChCB*PJph h..c5^Jhmh^ 5^J h5x5^Jh^ ^JmH sH hmOJQJ^Jh^ OJQJ^J h" L^J h^ ^Jhy]hJw\h(ohrhq1 $$Ifa$$If ^gdm^gdy]I & FEƀ <˦gd(o:88Vkd$$If40% c!  &af4p $If$Ifakd$$If40%c! &af4p{|  !!$"%"### #!#!$ )`0p@ P !$`'0*-^a$gd{> hgd d7$8$^gdph@ $d7$8$a$gd7 d7$8$gdpF  hh^hgd5x`gdm^gdpF  1 2 z { |  ! !! !6!p!s!!!!!#"%")"*"0"""""###### #!#ƻ៩wh{>CJOJQJ^JaJh{>CJaJ hoiCJ hCJ hCJhhph@5CJ hph@CJ hCJ h7CJh4ch4c0JCJh4ch{>0JCJjIh4chE CJU h4cCJjh4cCJU h{>CJh{>5CJ\*!#"###$#+#,#7#A#B#C#E#G#H#R#r#y#####2$4$6$7$>$?$E$O$P$Q$S$V$泧zvoi_UhL_~OJQJ^Jh4OJQJ^J hpF^J h:5\hJvhpFhpFB*ph hpFhpFhpFhpFB*CJ\phhB*CJ\phh5gRB*CJ\phhpFh B*CJ\phh^ OJQJ^Jh+*POJQJ^JhgWOJQJ^J h%-~^J h^ ^Jh^ CJOJQJh'CJOJQJ!###,#B#C#E#F#zt$If$Ifakd0 $$If40%c! &af4p $$Ifa$$If  ^`F#G###2$3$4$5$6$?$P${mg^ $$Ifa$$Ifh1$]h^gdOL h1$]h^^gdJv^gdL_~^gdpFgdpFVkd $$If40% c!  &af4p  P$Q$S$T$U$V$$DB<^Qkd $$If40! 3  af4p $If$If\kd` $$If40!3 af4pV$$$$$$$$$$$$$$$$$$$$$$$$$$$/%0%[%\%]%˶š}h}Ph/j hrhHCJOJQJU^JaJ)jhrhHCJOJQJU^JaJ hrhHCJOJQJ^JaJhHCJaJh24hHCJaJ(jh24hHCJUaJmHnHuh{0J"mHnHuhm hm0J"jhm0J"UhxVjhxVUhh^ B*phhB*phhhB*ph$$$$$$$$$$$$$$%%%%%^&gdH&&&`#$]%s%t%%%%%%%%%%ǹǹǧhh^ B*phhxVhmh'gCJOJQJ^JaJhHCJOJQJ^JaJ hrhHCJOJQJ^JaJ)jhrhHCJOJQJU^JaJ$hrhH0JCJOJQJ^JaJ (/ =!"#$% F }P;XJ,JFIF``C    #%$""!&+7/&)4)!"0A149;>>>%.DIC;C  ;("(;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;" }!1AQa"q2#BR$3br %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz w!1AQaq"2B #3Rbr $4%&'()*56789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz ?j( ( *:}2IE`ZVxH% T)yM6$y1 d; A+#у9՝xoV EԨ,pƭ&b祴f(1F=~U: MZ5 $Fܥz5׈5&{Uxˌ`u'ڷ|MSclMȜwIz[:l#bp*xh sɗ sc!Z뉦,_gy 6nz+E5S3FSǭQ;w$2DfP+ӡG=l3^9hD9WRWO,klTi V[]r*=-jTL_ljd:#<{m4 'P QY$,p:sN5KM[6DXS^Ok5qkk, rF?}InEP&h4Xqː?stﯙ Wԉc< j\[*PZDOa1S?k|?# **G''v3Y!^wLC~\NtYϩ!T8d]4m?YoRe# CRvXr[c;F.%v1A?qPj:?k=)20Xüb0HғCԧXJlpesNytX r~5-&xT񿉣쵺HszTzm<lG-|]: ;; a |;T)ߑ 7_OEu}\?%|G +GTw-͵ `mpYzq^[G uK(j5z2PkW;;"|Έ$&@mArێ=E{Ga"=FLq$mn¾wƓ=R M5 f~kϤ;r-%s2~5Rj>➳m-0pͺVMCt MyqڣG"{u}F+5sPU A_LWk׃zzWo+ǗrVڌIdv_&]~'Yi"%aم\QRdh+ģ:OeaFkbLYfR)敷1z = 5 I| ῑi]Т( ( OI>2OLsVnK_eWd40ڭÛKH# g'|}eoUB=]Nqƾg 0EvRw𧋴o 1%v4.6p^/xSR[wkFskzƼkoo[T8ܒj>k$:.?vc{=vEi"^0`bNAcx7w&&Ͻ!X!ݜ$v 4cԥR-4k[WE>>,vk^i-D(11v^cJFEgOq[w^-y#x4|C[SRAZ"1c#@Լ7av.ՇK. OVY B%'>\(g?ֹV I3+c@(!>,+cl0^^QB|Am0'|]D>=ڿDԲz^ 6A?:[FV򾟩k ֤kv/r88aַ5?>.dHR}܆`x"/{}FvvL7 ?oq ~k>)WFoҬj_C\$xϥfizM?z<׀q cn8f+^)dd+̥zvcx#*,l"fҼ By+#)_Ak~,H݇Ezwďj>Ү4"h o].1xj>gFUF |w_W}M ()c`їIψe Mg 1J3gAZa0:ݏGLjK>d snO3D 0rGYJMU V=0IHZp2) I?SV`]3=q[KPucZ$6qتTUd"/sמixOFp[ynK)`Mxgjh [;c!mDjVv$ȫiU[ě 8H?kkW59lia`ctki!+IܓuU>;.542@by2z u|"LKoiõeouou:Ɠki7:en B={[Y)b1t<%DB+*#-<[@5+PZnB}tAFS)j~5GV@+~-[u8?`wrWVG<;4OG-s5a[H#;Te9l*mm-_Klčo) T:d3\I#ɬMsI ;9 ɭi63ōĒI;G $GzXHlh`{c$vukqLh8a֬P3_iXXBLq2r}y} ĖYiz\[ߴ౎`*ǜV爴!YCͼCz99X&9@riVzIn$S : 2Юc+ۣ<zvzlښ54rúdQ]kֺbLBO,H$ #Y g -z _W}eYjPlC8Ձx H֋LlOY! }zxL̰n@acGj/878O!k 0n=NZ+^]ew>p0Jbhz5HuM`Fv*8<@ i* ( pl3<%lw3P{a񦏤ڼ:%R\ tڼǪvem iȒyAՏwSKBBqj?.4WTp018_ZMK'>CfQ$wY~)Kh-ݤ͆`K5 ].Kل6rNqڼsvmUS Sǡ38i^3AF溜d+o*\ڪY^"l5 M_u# Z9@goi:ז5Ҿɚl2#=knEO kvs\imq dq $PNO#❀o28<W_%oݼg7uZ 'Z-#X{[Jn|n#Y[A].?.5 )ih.krIo:4Ӭ| 8\h[hd4{ $ Hdr]QQT`ڟEHQ@Q@Q@Q@ *ɡ钬*l @ GGOִ( kSjX]lRH}MrZσ/X^Vn!}Ʋ,ۀ]z]囤K On'p+ecEDUҟE ( ( (?$$If!vh535 #v3#v :V 4 +,535 4af4p$$If!vh535 #v3#v :V 4  +535 4af4p $$If!vh553#v#v3:V 4; +,5534af4p$$If!vh553#v#v3:V 4  +5534af4p $$If!vh55 !#v#v !:V 4 %+,55 !4af4p$$If!vh55 !#v#v !:V 4  %+55 !4af4p DyK yK http://www.partners.org/phsqi/QIWeb/logs/Site Signature and Delegation Log2.dot$$If!vh55 !#v#v !:V 4 %+,55 !4af4p$$If!vh55 !#v#v !:V 4  %+55 !4af4p $$If!vh55!#v#v!:V 4 W&+,55!4af4p$$If!vh55!#v#v!:V 4  W&+55!4af4p $$If!vh55c!#v#vc!:V 4 &+,55c!4af4p$$If!vh55c!#v#vc!:V 4  &+55c!4af4p DyK yK vhttp://www.partners.org/phsqi/QIWeb/logs/AETrackingLog.xls$$If!vh55c!#v#vc!:V 4 &+,55c!4af4p$$If!vh55c!#v#vc!:V 4  &+55c!4af4p $$If!vh553#v#v3:V 4 +,5534af4p$$If!vh553#v#v3:V 4  +5534af4p DyK www.partners.org/phsqiyK <http://www.partners.org/phsqi^ 2 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 P`P Normal 8^8 @OJQJ_HmH nHsH tH@ Heading 1,H1-Sec.Head_xd$d0%d&d-D@&M N0OP^x@B*CJKHOJQJphJ@J  Heading 2$<@&56CJaJHH  Heading 3$<@& 5CJaJPP  Heading 4$<@&5CJOJQJaJHH  Heading 5 <@&56CJaJNN  Heading 6 <@&5CJOJQJaJll  Heading 7$$@&]^a$!5>*@CJ(OJQJ\aJtH \\  Heading 8$$@&^a$5@CJ\^JaJtH 6 6  Heading 9 @&CJDA`D Default Paragraph FontVi@V  Table Normal :V 44 la (k (No List POP Heading Base$$d @CJKH.B@. Body TextjOj Part Label*$d-D0$M ^a$@B*CJphrO"r Part Title*$dl-D0$M ^a$@B*CJTOJQJph`2` Company Name$$d0$^@CJ KHOJQJhOBh Chapter Title$dlx^a$@B*CJTOJQJphO Title Cover7$$ d$d0N0^5@CJ@KHOJQJrbr Return Address4$ pd(&#$+DH0$^@CJ^J@^ Subtitle'$$$dT<x@& ^a$ 5@aJH>@H Title$<@&a$5CJ KHaJ TT Header !^@CJOJQJaJtH pOp NIHD$ # p@ P  d^` a$ @CJtH 6U@6 Hyperlink >*B*ph.. mw-headlineb^@b Normal (Web)dd[$\$^@CJOJQJaJtH jOjData Field 11ptd7$8$^@CJ^JmHnHtH uDD  Balloon TextCJOJQJaJXPX Body Text 2 ^5@CJOJQJ\aJtH $$ spelle.)@!. Page NumberFV1F FollowedHyperlink >*B* phTCBT Body Text Indent$@CJOJQJaJtH `RR` Body Text Indent 2 %^@CJOJQJaJtH T @bT Footer& !^@CJOJQJaJtH `Sr` Body Text Indent 3 '^@CJOJQJaJtH ^^ Bulleted Normal!( 8^gd&/>*NN Bullet Normal 2) & FgdCR6]*W* Strong5\VQV  Body Text 3+x^@CJOJQJaJtH @@@ TOC 1,h^5;CJaJ>@> TOC 2-^ 5OJQJ66 TOC 3 .^OJQJ66 TOC 4 /^OJQJ66 TOC 5 0X^XOJQJ66 TOC 6 1 ^ OJQJ66 TOC 7 2^OJQJ66 TOC 8 3^OJQJ66 TOC 9 4x^xOJQJR Block Quotationw5$Xd$d  %d &d 'd -DM N  O P Q ]^Xa$OJQJ<b< Body Text Keep6$DD Picture7$ & F8^8`P"qP Caption8 & Fd<@CJOJQJ<q< Chapter Subtitle9J' J Comment ReferenceCJOJQJkHDD Footnote Base ;$dCJ44  Comment Text<@@ Table Text=<^CJ8Q8 Document Label><X < Emphasis@CJOJQJkH>* > Endnote ReferenceH*4+4  Endnote TextAN"N Header BaseB$ !d;CJza2z Footer Even(C$8dX$dN^8";@CJOJQJaJnHtHu|aB| Footer First(D$8dX$dN^8";@CJOJQJaJnHtHuxaRx Footer Odd(E$8dX$dN^8";@CJOJQJaJnHtHu@& @ Footnote ReferenceH*6r6  Footnote TextG Header EvenH$ & F8dX&d>T PTf^8";@CJOJQJaJnHtHu~~ Header First*I$$8d$dN^8a$";@CJOJQJaJnHtHu Header OddJ$ & F8dX&d>T PTf^8";@CJOJQJaJnHtHuJJ Index BaseKhd^h`CJ* * Index 1L8 8 Index 2Md^8 8 Index 3N8d^88 8 Index 4Od^88 Index 5Pd^`!`  Index HeadingQ$d^@CJKHOJQJL/!L Lead-in Emphasis@CJOJQJkH2( 2 Line NumberCJ4/B4 ListT^`02AR0 List 2 U^03Ab0 List 3 Vp^p04Ar0 List 4 W ^ 05A0 List 5 X@ ^@ @0A@ List BulletY & F >6> List Bullet 2 Z^>7> List Bullet 3 [p^p>8> List Bullet 4 \ ^ >9> List Bullet 5 ]@ ^@ DA List Continuen^ & F>T.Tf`BEB List Continue 2 _p^pBFB List Continue 3 ` ^ BGB List Continue 4 a@ ^@ BH"B List Continue 5 b ^ :1A2: List Number c & F>:1B> List Number 2 d^>;1R> List Number 3 ep^p><1b> List Number 4 f ^ >=1r> List Number 5 g@ ^@ RR Table Headerh$<^a$ CJOJQJhIh Message Header*i$ H@@pdx]p`@CJ>> Normal Indent j^NN Part Subtitle k$hx 6CJKH:: Section Headinglhh Section Label#mh&dP^@CJ6OJQJ00 Slogan 6@CJQ Subtitle Cover8o CCd$dN]C^C5@CJ0OJQJ4/4 Superscript5H*\,\ Table of Authoritiesq  ^`F"F TOC Baser P d^L#!2L Table of Figuress^`P.P  TOA Heading t$d5@KHOJQJPRP Bold Titleu^@CJKHaJb/bb Default v7$8$H$-B*CJOJ QJ ^J _HaJmH phsH tH LZrL Plain Text w^@OJ PJ QJ tH vv Preformatted0x # ~= z9!v%^@OJ QJ htH ^Y^  Document Mapy-D M ^@OJ QJ tH \\ Texto de balo z^@CJOJ QJ ^J aJtH P/P txni{$d1$a$CJOJ QJ _HmH sH tH NLN Date|7$8$^@CJOJ QJ ^J aJtH XX Quick A.} & F1$7$8$@CJOJ QJ ^J aJtH  Reminder List 1!~ & F hdx7$8$'5@B*CJOJQJ\aJphtH  Reminder List 2+ & F hd<7$8$^!@B*CJOJQJaJphtH vv Reminder List 3% & F h88<7$8$^8@CJOJQJaJtH fOf Data Field 11pt-Single7$8$^@CJ^JtH O" !Document Char Char Char Char CharE 8`0p@ P !$`'0*-^@CJOJQJtH T2T Data Field 10pt7$8$^ @^JtH h/h Title 2 - Small$7$8$a$"5OJQJ\^J_HmH sH tH FF Style1 h^h5CJPJ\FqbF Style2 h^h5CJPJ\FqrF Style3 h^h5CJPJ\FqF Style4 h^h5CJPJ\>> Style5d^CJ]BB Style6d^ CJ\aJPK![Content_Types].xmlj0Eжr(΢Iw},-j4 wP-t#bΙ{UTU^hd}㨫)*1P' ^W0)T9<l#$yi};~@(Hu* Dנz/0ǰ $ X3aZ,D0j~3߶b~i>3\`?/[G\!-Rk.sԻ..a濭?PK!֧6 _rels/.relsj0 }Q%v/C/}(h"O = C?hv=Ʌ%[xp{۵_Pѣ<1H0ORBdJE4b$q_6LR7`0̞O,En7Lib/SeеPK!kytheme/theme/themeManager.xml M @}w7c(EbˮCAǠҟ7՛K Y, e.|,H,lxɴIsQ}#Ր ֵ+!,^$j=GW)E+& 8PK!Ptheme/theme/theme1.xmlYOo6w toc'vuر-MniP@I}úama[إ4:lЯGRX^6؊>$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! I_TS 1?E??ZBΪmU/?~xY'y5g&΋/ɋ>GMGeD3Vq%'#q$8K)fw9:ĵ x}rxwr:\TZaG*y8IjbRc|XŻǿI u3KGnD1NIBs RuK>V.EL+M2#'fi ~V vl{u8zH *:(W☕ ~JTe\O*tHGHY}KNP*ݾ˦TѼ9/#A7qZ$*c?qUnwN%Oi4 =3ڗP 1Pm \\9Mؓ2aD];Yt\[x]}Wr|]g- eW )6-rCSj id DЇAΜIqbJ#x꺃 6k#ASh&ʌt(Q%p%m&]caSl=X\P1Mh9MVdDAaVB[݈fJíP|8 քAV^f Hn- "d>znNJ ة>b&2vKyϼD:,AGm\nziÙ.uχYC6OMf3or$5NHT[XF64T,ќM0E)`#5XY`פ;%1U٥m;R>QD DcpU'&LE/pm%]8firS4d 7y\`JnίI R3U~7+׸#m qBiDi*L69mY&iHE=(K&N!V.KeLDĕ{D vEꦚdeNƟe(MN9ߜR6&3(a/DUz<{ˊYȳV)9Z[4^n5!J?Q3eBoCM m<.vpIYfZY_p[=al-Y}Nc͙ŋ4vfavl'SA8|*u{-ߟ0%M07%<ҍPK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 +_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!Ptheme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK]    : N RC|h !#V$]%%"%'-136:;?A,  # }M?XV!#F#P$$% !#$&()*+,./0245789<=>@/U91{ XX  u!!Xt  ,R$ }P;XJ,*@ 0(  B S  ?v(  >  s A . \\SFA6\SFA\vss2\Local Settings\Temporary Internet Files\OLK7A8\QI_color_mac.jpguR`TuR`T#" `?"l@ _Toc475290317 _Toc475901425 _Toc475902158 _Toc160263151 _Toc179019464 _Toc179019465 _Toc179019466 _Toc179019467 _Toc179019468 _Toc470496386 _Toc483995665 _Toc179019470 _Toc483995666 _Toc179019471 _Toc470496387 _Toc179019472 _Toc179019473 _Toc179019474 _Toc179019475 _Toc483995681 _Toc179019476 _Toc179019477 _Toc179019478 _Toc179019479 _Toc483995692 _Toc179019480 _Toc1790194859QY?|,GG? )))c.|R 722Ob< b b| b b b| b b< b8 b8 b9 b; b: b\: ddz     y   = *urn:schemas-microsoft-com:office:smarttags PlaceType=*urn:schemas-microsoft-com:office:smarttags PlaceName>*urn:schemas-microsoft-com:office:smarttags PostalCode; *urn:schemas-microsoft-com:office:smarttagsaddress9*urn:schemas-microsoft-com:office:smarttagsState: *urn:schemas-microsoft-com:office:smarttagsStreet9 *urn:schemas-microsoft-com:office:smarttagsplace8 *urn:schemas-microsoft-com:office:smarttagsCity    9MQ1u#d9Q CMFX+}1#G6V91Ř7y|`\v6Ipb~X'Q,xF.]!Ba3(ʮ~C5@GH#WcKJYSTUxq@%cL_*+T`3rʀ- g:Rz g [ h`W - jvX)'pNx}#q_"Zw.ˈqk`~*+*hh^h`OJQJ^Jo(d808^8`0o( ^`hH. pLp^p`LhH. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.h^`OJQJo(hHh^`OJ QJ ^J o(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHohPP^P`OJQJo(hHh^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hHh^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hHhh^h`OJQJ^Jo(rh^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hHh^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hH^`CJOJQJo(nh^`OJQJo(hHh  ^ `OJ QJ ^Jo(hHoh  ^ `OJQJo(hHhxx^x`OJQJo(hHhHH^H`OJ QJ ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^Jo(hHoh^`OJQJo(hH@h^`56CJOJQJo()h808^8`0o( ^`hH. pLp^p`LhH. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.hh^h`B*OJQJ^Jo(phh ^`5hH.h^`.- 0 ^ `0o(h@ @ ^@ `.h^`.hL^`L.h^`.h^`.hPLP^P`L.h^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hH88^8`OJQJo(hHpp^p`OJ QJ o(hHo@ @ ^@ `OJQJo(hH^`OJQJo(hH^`OJ QJ o(hHo^`OJQJo(hH^`OJQJo(hHPP^P`OJ QJ o(hHo  ^ `OJQJo(hHh ^`OJQJo(h^5o(()h L ^ `L.h  ^ `.hxx^x`.hHLH^H`L.h^`.h^`.hL^`L. @0^`0.@0^`0.@p0^p`0.@@ 0^@ `0.@0^`0.@0^`0.@0^`0.@0^`0.@P0^P`0h^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hHh^`OJQJo(hHhpp^p`OJ QJ ^J o(hHoh@ @ ^@ `OJQJo(hHh^`OJQJo(hHh^`OJ QJ ^J o(hHoh^`OJQJo(hHh^`OJQJo(hHhPP^P`OJ QJ ^J o(hHoh  ^ `OJQJo(hHh808^8`0o( ^`hH. pLp^p`LhH. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.ST- g- j+!cKUk`~'pya3(T`[ h\vZw g.]!X'QGH#qpL_C5$ @x^`CJOJQJo(^YЬ                                                              r 6W               zt        `~                                 iOsr; ) ^ 9Bh{'[)(HV\Y8[T"c;#}#f&&U&?)./i/{80[W246b6 `7dH8%9.<9:/:X:Ln;{>V??ph@A:AjBUFpF HJ4hJ" LOLO.sO+*POP5gRxV $Wl|Wv2Y[Jw\y]g`a..c4c f;f8g'gPgj\lmKno(oqu[w5x%-~L_~yVc,Nn@Va(0Px4 02oZ6}&98 }k/XLgWR*'wj7a'c'O`q1 oi7_Z=D(vj E o - u&P53|rF- gJv>bt^CCs@P@Unknowndlb23Partners Information SystemsG*Ax Times New Roman5Symbol3. *Cx ArialG5  jMS Mincho-3 fg7.@ Calibri?. Arial BlackCbwLucida GrandeA. Arial Narrow5"SystemMCentury Schoolbook?= *Cx Courier New3*Ax Times5. .[`)TahomaGACaslon Regular;. *Cx Helvetica;WingdingsEMonotype SortsACambria Math 1hI{%I{%FIq4Iq44d 2qHX ?^ 2!xx Travis BesangerPartners Information Systemsd                 Properties 196-84e7-ad13f8230006;#3;#BWH|85502b99-e70f-4ed3-b38f-d2fd5f669377;#36;#Guidance/Instructions|18e2a486-65c4-42b7-817a-8598be7c5098;#1;#MGH|afa34695-9b57-45e7-acca-909cfb8c3888]]>eDescription="Create a new document." ma:contentTy s/metaAttributes"> ;http://www.partners.org/phsqi/QIWeb/logs/AETrackingLog.xlsp+Phttp://www.partners.org/phsqi/QIWeb/logs/Site Signature and Delegation Log2.dotX_http://www.partners.org/phsqiK\P\\SFA6\SFA\vss2\Local Settings\Temporary Internet Files\OLK7A8\QI_color_mac.jpgwFDA SI checklistSWHITE12@PARTNERS.ORGWhite, Sarah Aliciafϕ47Gomez, MicheleQ31;#Human Research Quality Improvement (QI)|71f16483-8b45-4039-b174-4a4f7fc56e61;Guidance/Instructions|18e2a486-65c4-42b7-817a-8598be7c5098.Partners|2dd0f40d-214d-4a0c-9a7d-35ef1a4b577c?36;#Guidance/Instructions|18e2a486-65c4-42b7-817a-8598be7c5098213;#Partners|2dd0f40d-214d-4a0c-9a7d-35ef1a4b577cMHuman Research Quality Improvement (QI)|71f16483-8b45-4039-b174-4a4f7fc56e6131;#Human Research Quality Improvement (QI)|71f16483-8b45-4039-b174-4a4f7fc56e61;#13;#Partners|2dd0f40d-214d-4a0c-9a7d-35ef1a4b577c;#10;#Spaulding|e185c94c-b3eb-4e19-b308-5825abe292ed;#7;#McLean|5c1ced02-1ff6-4196-84e7-ad13f8230006;#3;#BWH|85502b99-e70f-43;#BWH|85502b99-e70f-4ed3-b38f-d2fd5f669377;#7;#McLean|5c1  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLNOPQRSTVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root Entry Fm- Data M1TableUxWordDocumentSummaryInformation(DocumentSummaryInformation8dCompObjyMsoDataStore Fm-m- !"#  F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89qDocumentLibraryFormDocumentLibraryFormDocumentLibraryForm This value indicates the number of saves or revisions. The application is responsible for updating this value after each revision. w>