ࡱ> mpl gbjbjBrBr 4n  S8IT/(!!!///////1h4&/!!!!!/H/9"9"9"!/9"!/9"9"n+o-ܞ!^, s//0/,5 ".5@o-5o-!!9"!!!!!//9"!!!/!!!!5!!!!!!!!! : Tool Summary Sheet Tool:Site Initiation Visit Agenda TemplatePurpose:This template can be used as a starting point for planning a site initiation visit meeting.Audience/User:Clinical Investigators, site study coordinators, OCTOM, and CROMSDetails:Site initiation visits occur prior to site activation for a specific protocol. These visits have several goals: to orient and train staff on the protocol and study related processes; to confirm readiness for study implementation; and to identify additional requirements that must be satisfied prior to site activation and subject recruitment. This template provides a suggested list of items to be discussed during a site initiation visit. Provided durations are estimates only. Site initiation visits will be supported by the NIDCR as the study sponsor, in accordance with ICH guidelines. Best Practice Recommendations:Define who is responsible for customizing the agenda, leading the meeting, and ensuring that all relevant parties are informed of the meeting date and time commitment well in advance. This can/will be done in collaboration with NIDCR, OCTOM, and/or CROMS. Customize the list of topics, order of presentation, and duration of each discussion item to the specific needs and requirements of the study. Include the name of each individual who will be the owner/presenter of each item. The order of agenda topics is a best practice recommendation. Irrespective of customization, it is recommended that protocol overview and MOP review remain together. It is also recommended that review of roles and responsibilities occur early in the meeting. In the template, the instructions and explanatory text are indicated by {blue italics} (CROMS_Instruction style). Instructional text will also be enclosed in braces to signify this text for screen-readers used by the visually impaired. Delete template-specific instructional text as well as this Tool Summary Sheet when customizing the agenda for the meeting. Text enclosed with <> is a placeholder for a specific detail (e.g., ); replace as appropriate. The following pre-requisites should be completed prior to the site initiation visit: protocol and consent have been reviewed and approved by any required Scientific Review, the DSMB, and the IRB; the case report form and data collection system have been finalized; the Manual of Procedures (or set of study specific Standard Operating Procedures have been prepared); and all necessary site staff have been identified.  Tool Revision History: VersionNumberDateSummary of Revisions Made:1.008DEC2010Approved version2.029NOV2011Added text to best practices bullets, updated ICF to consent document, and included additional discussion topics Site Initiation Visit Agenda Protocol Number: Principal Investigator: Meeting Date/Start Time: Attendees: AffiliationNameRole or Title<(e.g., OCTOM, Clinical Site, CROMS)> {This agenda assumes a two day visit of 9.0 working hours not including lunches or breaks.} TopicPresenterDuration/Total Time in hoursWelcome and Opening Comments Statement of visit objectives Review of agenda.25/.25Introductions/Roles and Responsibilities Site NIDCR/OCTOM CROMS (Rho) Communication Flow {Consider using the Delegation of Responsibilities Log to guide some of the introductions.}.5/.75Investigator Responsibilities Good Clinical Practice (GCP) Records Retention .5/1.25Protocol Overview Type of study Study objectives Enrollment goals Recruitment Plans Informed Consent Discussion Key inclusion/exclusion criteria Study visit schedule/schedule of events Study procedures1.0/2.25Manual of Procedures (or Discussion of SOPs and General Study Procedures, if no MOP exists) Review/Patient Walk Through Discussion of necessary updates1.5/3.75Safety: Definitions, Collection, and Reporting Adverse Events (AEs) Serious AEs (SAEs) Unanticipated Problems (UPs) Queries resulting from the above.5/4.25Data Collection/Source Documentation Paper or Electronic Data Capture (eDC) CRF discussion Source Documents Definitions of Retention of eDC/RAVE training (if applicable) Query process Differences from Safety queries1.5/5.75Investigational Product (if applicable) Description of Product Review of Investigator Brochure (IB) or Package Insert (if applicable) Storage Dosing Instructions Dispensing Documentation Accountability Return/Destruction Considerations Unblinding Procedures (if applicable).5/6.25Specimen Processing Collection Storage Shipping Lab Tracking Training (if applicable) .5/6.75Clinical Monitoring Contacts Responsibilities of Frequency Close out procedures1.0/7.75Investigator Site File Review Structure of the Regulatory Binder as well as Essential Documents to include: 1572, 1571, Form 1195 (as applicable) IRB approval documents: protocol, patient handouts, advertisements, consent document Document updates.5/8.25Tour of Facilities.5/8.75Closing/Review of Action Items.25/9.0     Template Version 2.0-20111129 Page  PAGE 3 of  NUMPAGES 5 )/?@I      ^ s  ' 1 @ Y Z ڵڵڵ馗ˈ˦yh\NhmH nH sH tH h\Nh,@0mH nH sH tH h\Nh 7mH nH sH tH h\Nh:YmH nH sH tH h\Nh mH nH sH tH  hw hBh\Nh;mH nH sH tH h\NhBmH nH sH tH h\NhB5mH nH sH tH  h+hB)?@I@Tkd`$$Ifl06 '(@ t644 layt+Tkd$$Ifl06 '(@ t644 layt+ $Ifgd+ %$IfgdJvgd+ Z T Tkd$$Ifl06 '(@ t644 layt+ $Ifgd+ %$IfgdJv    S T U t , s t   ' U V YĽ|sf_Rh+h 6B* php h+hd}Fh+hd}F6B* phI}h+h 0J/ h+h/ h+hw h+hq= h+h:Y h+h h+h^= h+hFeh\NhB5mH nH sH tH  hw hBh\NhmH nH sH tH h\NhjNmH nH sH tH h\Nh;mH nH sH tH h\NhamH nH sH tH  T U t t V YH3 "$Ifgd+ %$IfgdJvTkd $$Ifl06 '(@ t644 layt+ 3#$'(12BCDGzkz[h\NhmWi5mH nH sH tH h\Nh(7mH nH sH tH h\Nh mH nH sH tH  h' hB#h' hB5CJOJQJ^JaJh\NhBmH nH sH tH h+hB0J0 hB5>* hRn5>* hw hB h+h/ h+hI* h+h h+h(7 h+hd}F h+h h+hq=# $Ifgd+ $Ifgd+ gd+gdBTkd$$Ifl06 '(@ t644 layt+#{{{ $Ifgd+{kd$$Ifl0 $R  t0644 layt+#$(2Cqhhh $Ifgd+kd$$IflFF $ t06    44 layt+CDHRqhhh $Ifgd+kd6$$IflFF $ t06    44 layt+GHIJQRvwϯϏohYRC< h' h5_h5_5CJOJQJ^JaJ h' hwhw5CJOJQJ^JaJ h' hBh\Nh( 5mH nH sH tH h\Nhb5mH nH sH tH h\Nh[5mH nH sH tH h\NhZ5mH nH sH tH h\Nh5mH nH sH tH h\Nh^=5mH nH sH tH h\Nh*:5mH nH sH tH h\Nh5mH nH sH tH h\NhB5mH nH sH tH qddW $Ifgdw $Ifgd' kd$$IflFF $ t06    44 layt+qddW $Ifgdw $Ifgd' kd$$IflFF $ t06    44 layt+-Vmqjeeeeee` gd}1gd}gd+kdC$$IflFF $ t06    44 layt+ -EFGVXm"#$ž̷̷̰xndheh\20J/6heh6Q0J/6heh/0J/6heh)A0J/6hehP/0J/6hP/ hh,Oh\Nh,OmH nH sH tH  h+h,O h+h(7 h+hVy9 h+hYb h+hDh}hD0J$h}hYb0J$h}h*:0J$h}hB0J$h+hB5#e\\\ $Ifgd}kd$$IflF ^' K\ t06    44 layt} $$Ifa$gd}qccc$$Ifa$gd+kd$$IflF ^' K\ t06    44 layt+qccc$$Ifa$gd+kdJ$$IflF ^' K\ t06    44 layt+W]gqlg^^^ $Ifgde2gde gd}kd$$IflF ^' K\ t06    44 layt+$%&.23STVWpvz!4;uf_XTM hehP/h*: h+h hd}FhJh\Nh)AmH nH sH tH h\Nh' mH nH sH tH  h+hD h+hF hehF hd}Fh0nh\NhF mH nH sH tH h\NhJmH nH sH tH h\NhDmH nH sH tH heh:l0J/6heh6Q0J/6heh/0J/6hehP/0J/6heh0J/6of]]OF $Ifgded$Ifgd+ 4$Ifgde 3$Ifgdekd$$Ifl4FJ' t06    44 layt+ !4qh____VHd$Ifgd+ 2$Ifgde 4$Ifgde 3$IfgdekdH $$IflFJ' t06    44 layt+3Eb")@bfjklĽ⯨Ľvg`Yg h+hJ hd}Fhi&h\Nhi&mH nH sH tH h\NhrmH nH sH tH  h+h)A h+h:l h+hi& h+h heh h+hF hd}Fh' h+h' hd}FhF h\NhF mH nH sH tH h\Nh)AmH nH sH tH h\Nh' mH nH sH tH h\NhmH nH sH tH "h_VVH? $IfgdJvd$Ifgd+ 4$Ifgde 3$Ifgdekd $$IflFJ' t06    44 layt+ $Ifgde"3Ebqh___V___ 5$Ifgde 4$Ifgde 3$Ifgdekd $$IflFJ' t06    44 layt+ #AabQH 3$IfgdekdC $$IflFJ' t06    44 layt+ $IfgdJvd$Ifgd+ 4$Ifgdebklh_VVVVHd$Ifgd+ 4$IfgdJv 3$IfgdJvkd $$IflFJ' t06    44 layt+ $IfgdJv     fƿ԰ԓԓԂ{l]V hd}Fhi&h\Nhi&mH nH sH tH h\Nh' mH nH sH tH  h+h*: hqa ^J hd}Fh*:h*: h+hi& hd}Fhqa h\Nhqa mH nH sH tH h\NhmH nH sH tH  hJvhJ h+hJ h+h h+hqa hd}FhF h\NhF mH nH sH tH h\NhrmH nH sH tH   1hyh_VVMMV 5$IfgdJv 4$IfgdJv 3$IfgdJvkd $$IflFJ' t06    44 layt+ $IfgdJv0H? 3$IfgdJvkd> $$IflFJ' t06    44 layt+ $IfgdJvd$Ifgd+ 5$IfgdJv 4$IfgdJv0x  $IfgdJvd$Ifgd+ 4$IfgdJv "-5>efnqh____QH $IfgdJvd$Ifgd+ 4$IfgdJv 3$IfgdJvkd $$IflFJ' t06    44 layt+fimno6ͷԊ{tmga]VԨ h+h*:h*: hu^J h^J h+h/ h+huh\NhumH nH sH tH h\Nh mH nH sH tH h\NhGCmH nH sH tH h\Nh' mH nH sH tH h\Nh\2mH nH sH tH  h+hR h+hJ h+hMy hd}FhJh\NhrmH nH sH tH h\NhJmH nH sH tH noqh____QH $IfgdJvd$Ifgd+ 4$IfgdJv 3$IfgdJvkd$$IflFJ' t06    44 layt+6\qh_VVVHd$Ifgd+ 4$IfgdJv %$IfgdJv 3$IfgdJvkd9$$IflFJ' t06    44 layt+h_Qd$Ifgd+ 3$IfgdJvkd$$IflFJ' t06    44 layt+ $IfgdJv  #8@FGMNOPTU`abcdefgԯꨠrrnh PjheUmHnHuh`jmHnHujheU h}heheh\Njh\NU hd}FhDh\NhrmH nH sH tH  h+hEh\NhGCmH nH sH tH h\Nh' mH nH sH tH  h+hMy hd}FhMyh\NhMymH nH sH tH * qhZQ $IfgdJvd$Ifgd+ 3$IfgdJvkd$$IflFJ' t06    44 layt+qlb`b`Y`b`d dgdD gdJvkd4$$IflFJ' t06    44 layt+  !"#defg gdJvgd}d dgdD21h:p+/ =!8"8#8$8% ^$$If!vh5 5#v #v:V l t65(5@yt+^$$If!vh5 5#v #v:V l t65(5@yt+^$$If!vh5 5#v #v:V l t65(5@yt+^$$If!vh5 5#v #v:V l t65(5@yt+^$$If!vh5 5#v #v:V l t65(5@yt+$$If!vh5R 5#vR #v:V l t06,5R 5/  yt+$$If!vh555#v#v#v:V l t06,555yt+$$If!vh555#v#v#v:V l t06,555yt+$$If!vh555#v#v#v:V l t06,555yt+$$If!vh555#v#v#v:V l t06,555yt+$$If!vh555#v#v#v:V l t06,555yt+$$If!vh5 5K5\ #v #vK#v\ :V l t06,5 5K5\ yt}$$If!vh5 5K5\ #v #vK#v\ :V l t065 5K5\ yt+$$If!vh5 5K5\ #v #vK#v\ :V l t065 5K5\ yt+$$If!vh5 5K5\ #v #vK#v\ :V l t065 5K5\ yt+$$If!vh555#v#v#v:V l4 t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+$$If!vh555#v#v#v:V l t06555yt+j6 666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ OJPJQJ_HmH nH sH tH J`J eNormal dCJ_HaJmH sH tH L`L + Heading 1 @&a$5CJmHsHtHDA D Default Paragraph FontRi@R 0 Table Normal4 l4a (k ( 0No List 44 D0Header H$.. D0 Header Char0 `0 }0Footer `'>/!> }0 Footer CharCJOJQJaJj3j D Table Grid7:V0<@B< F List Paragraph^H RH F  No SpacingCJ_HaJmH sH tH Z bZ i&0 Balloon Text dCJOJQJaJmHsHtHN/qN i&0Balloon Text CharCJOJQJ^JaJB' B I*0Comment ReferenceCJaJ<< I*0 Comment TextCJaJ:: I*0Comment Text CharLj L I*0Comment Subject5\mHsHtHF/F I*0Comment Subject Char5\`O` d}FCROMS_Instructiondh<x6B* OJQJphI}@/@ +Heading 1 Char 5CJaJhh Body Text Right Aligndxa$5CJOJQJ^JLB`L !+0 Body Text dxOJQJmHsHtHD/D +0Body Text CharCJOJQJaJH0@"H +0 List Bullet" FdxOJQJB/1B  Blue Font6B* CJOJQJphI}*W`A* `Strong5\JP`ARJ &Jv0 Body Text 2%OJQJmHsHtHH/aH %Jv0Body Text 2 CharCJOJQJaJBQ rB (0 Body Text 3'CJmHsHtHT/T '0Body Text 3 Char6B* CJOJQJaJphI}J1AJ 0 List Number )^CJOJQJ^JN:AN 0 List Number 2 *^CJOJQJ^JN;AN 0 List Number 3 +^CJOJQJ^JXC AX -0Body Text Indent,CJOJQJmHsHtHV/V ,0Body Text Indent CharCJOJQJ^JaJD D0Revision.CJ_HaJmH sH tH 8o8 + BlueItalic 6B* phI}0o0 + Underscore>*<O< }Center 1a$ OJQJ^JBO"B eBlueItalicParagraph24/@A24 e0List 3 FOJQJ<2@AB< e0List 2 4 & FOJQJ<3@AR< e0List 3 5 & FOJQJPK![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] gn RRRU G$fg"%*/3T #Cb0 ng !#$&'()+,-.0124563:<AMOU!T  # @H 0(  0(  B S  ?SV !"#FPTceh !"#ehFPTch |x&}}l~hJߺss@6F^NCb!TR"3,AtS9345^`.^`.88^8`.^`. ^`OJQJo( ^`OJQJo( 88^8`OJQJo( ^`OJQJo(hh^h`. hh^h`OJQJo( ^`OJQJo(^`OJQJ^Jo(o p^p`OJQJo( @ ^@ `OJQJo(^`OJQJ^Jo(o ^`OJQJo( ^`OJQJo(^`OJQJ^Jo(o P^P`OJQJo(^`.^`.pL^p`L.@ ^@ `.^`.L^`L.^`.^`.PL^P`L.^`.^`.pL^p`L.@ ^@ `.^`.L^`L.^`.^`.PL^P`L. AtS3,Cb!~}| . i                 [LnDZ"      {Ua7( qa Fe[Jv\N l i& F W$& (1(JX.P//,@0me5(7_7Vy9*:Z7:;[<^=q=Ed}Fl J,O6QAR6WY:Y bOfmWi0nhxbz0-z} P\2L6Rn = >U6GFB=' wrsG0Y)A`je 7I* ?RMyZz_YbI5_bre StPD "k=J+gowwGC9R\\H(y}jN[:lu@g@UnknownG*Ax Times New Roman5Symbol3. *Cx Arial7.@ Calibri5. .[`)Tahoma?= *Cx Courier New;WingdingsA$BCambria Math"1hC C  $ $!88nr0  CHX  (G2xx%Site Initiation Visit Agenda TemplateTool Summary Sheet=site, initiation, data, source, documentation, accountabilityNIDCRCathy@         Oh+'04H Xd   (Site Initiation Visit Agenda TemplateTool Summary SheetNIDCR@site, initiation, data, source, documentation, accountability Normal.dotmCathy2Microsoft Office Word@@@՜.+,0 hp   RHO, Inc.$   &Site Initiation Visit Agenda Template Title  !"#$%&'()*+,-./012345679:;<=>?@BCDEFGHIJKLMNOPQRSTUVWXYZ[]^_`abcefghijknosrtvwxyz{|}~Root Entry FI'LqData 81TableA5WordDocument 4nSummaryInformation(\DocumentSummaryInformation8dMsoDataStoreI'LI'LL3F1V1E30PHLWA==2I'LI'LItem  PropertiesUCompObj yYEEBT4Q==2 I'LI'L    F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89q Item  uP"Properties QZ4NUA5OA==2 I'LI'LItem Properties This value indicates the number of saves or revisions. The application is responsible for updating this value after each revision. DocumentLibraryFormDocumentLibraryFormDocumentLibraryForm