ࡱ> `d_ ,bjbj)) n@rCAgrCAg   $P,F*f(:::U*W*W*W*W*W*W*$<-/{*:::::{*H*TTT:U*T:U*TT&x( kdj5("A**0*W(j0&.0D((0(l::T:::::{*{*T:::*::::0::::::::: X l: Tool Summary Sheet Tool:Delegation of Responsibilities Log Purpose:To record all study staff members significant study-related duties. Audience/User:Principal Investigators (PIs), Study Coordinators, other site staff, clinical monitorDetails:This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator. It is required for both observational and interventional clinical research studies.Best Practice Recommendations:List the names of study staff members and record the responsibilities that have been assigned to them using the Responsibilities Legend. Revise the Responsibilities Legend as needed to reflect study-specific needs, such as signing CRFs and reviewing/signing laboratory reports. Each study staff member listed should initial and sign to indicate understanding of the responsibilities assigned. The site PI should initial and date each line of the form as entries are recorded. The PIs signature at the bottom of each form is required at the conclusion of the study. Update the log as needed following any change in site study personnel. Number each page and maintain this log in the Essential Documents Binder, behind the Delegation of Responsibilities (DoR) Log tab. (Synonyms for this binder include Investigator Binder, Regulatory Binder, Investigator Site File (ISF), and Study File.) Store pages in reverse chronological order, with the newest pages of the log placed at the front of the section. At the conclusion of the study, identify the final page of the log by checking the box in the footer. Remove this Tool Summary Sheet before use of the log.Tool Revision History: VersionNumberDateSummary of Revisions Made:1.005Feb2010First approved version2.002Mar2010Removed automatic page numbering3.004Jan2012Added Tool Summary Sheet; minor updates to Responsibilities Legend4.014Mar2012Updated Tool Summary Sheet; added * cross-reference and Query Management to Responsibilities Legend; added check box to footer  Delegation of Responsibilities Log Investigator Name:Protocol: Site Number:List staff to whom the Principal Investigator (PI) has delegated significant study-related duties. NameResponsibilities* Initials SignatureStart DateEnd DatePI Initials/Date By initialing above, I, the PI, declare that during the conduct of the above study, I have delegated the following study-related activities: *Responsibilities LegendAdminister Consent Screen Subjects Obtain Medical History Perform Physical Exam Determine EligibilityRandomize Subjects Dispense Study Drug Drug Accountability Assess Adverse Events Complete Source DocumentsComplete Study Forms Provide Discharge Instructions Make Follow-up Phone Calls Query Management Signature of Principal Investigator: __________________________________________________ Date: _______________________     Version 4.0 - 2012-03-14 Page _________ Check if final page of log: (  Page  PAGE 1 of  NUMPAGES 1 >?HV         > + X ^ ` u Z੩hXh@[/h8hP h&Kh&K h&KhD7 h-Mh[M h-MhD7hm h%hD7hD7 hhD7 hw hD7 h]hD7 hmhD7A>?HTkd$$Ifl0$(@ t644 laytKK $Ifgdm $Ifgdmgdm ETkd$$Ifl0$(@ t644 laytKK $Ifgdm $IfgdmTkdP$$Ifl0$(@ t644 laytKK   > Z $Ifgd% $IfgdmTkd$$Ifl0$(@ t644 laytKK  $IfgdKK $$Ifa$gd%gd%Tkd@$$Ifl0$(@ t644 laytKK./04>Yjl 567JVcdߴƴߠ~ h7hQh%hQ0J h%h%hQ hFEhQh ~5CJ^JaJh%h0J h%h'0J h%h%0J h%h/0J hcOhh%h0J hcOhD7hcOhD75h%hD70J h%hD70J!.yyy $Ifgd%}kd$$Ifl0 $"F t0644 layt%offf $Ifgd%kd+$$IflF $fF t06    44 laytD7/offf $Ifgd%kd$$IflF $fF t06    44 laytD7/04>offf $Ifgd%kdU$$IflF $fF t06    44 laytD7offf $Ifgd%kd$$IflF $fF t06    44 laytD767JVco_ZZQQQ $Ifgd%gd%$ xha$gdQkd$$IflF $fF t06    44 laytD7cdojaaaaaaa\Ff $Ifgd%"gd%kd$$IflF]2)(5 t076    44 layti d !"#$%&'()*+,-./0123456789:;<=>?@AB $:PcwhKlhcaJ hFEhQ h7hQh%h0J h!chQh7hQ5^Jh7hQ^J h7hoGh%hQ0J h%hQD !"#$%&'()*+,-./01234Ff Ff Ff xx$Ifgdi456789:;<=>?@AB $Ifgd%"gd%Ff?Ff& xx$Ifgdi $:Pcw zzzzzzzzzzzzz $Ifgd%|kdD$$IfTl4:bO57  044 laf4p ytiT ǿ}o j*h <h@[/CJaJh@[/5CJaJhN%h@[/CJaJh@[/CJaJhFEhCJhCJaJhFEh@[/CJh Uh^hWjhWUhQ hhQ hchQhhQ5aJhh5aJ haJ hFEhQ hcaJ+ fa\Z\ZZZgdN%"gd%kd$$IfTlKFb"O50    44 laytiT $Ifgd% ()*+,"gd%$a$$ P20]0a$gdFE$ HP0]^0a$gd 2gdN%  $%&'()*+,hQhWhG5mHnHu h@[/5jhJH5CJUaJh@[/joh UUh UhFEh@[/CJ5 01h:p ~/ =!"#$% 51h0:pFE= /!"#$% N$$If!vh#v(#v@:V l t65(5@ytKKN$$If!vh#v(#v@:V l t65(5@ytKKN$$If!vh#v(#v@:V l t65(5@ytKKN$$If!vh#v(#v@:V l t65(5@ytKKN$$If!vh#v(#v@:V l t65(5@ytKK$$If!vh#v"#vF:V l t06,5"5F/  yt%$$If!vh#vf#v#vF:V l t065f55FytD7$$If!vh#vf#v#vF:V l t065f55FytD7$$If!vh#vf#v#vF:V l t065f55FytD7$$If!vh#vf#v#vF:V l t065f55FytD7$$If!vh#vf#v#vF:V l t065f55FytD7$$If!vh#v#v#v :V l t076555 ayti$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd$$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd$$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd $$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd$$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd$$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#vs #v#v8#v #v#v:V l t0,5s 5585 55apFytiTkd+$$IfTl֞%  $)0s 8  t044 lapFytiT$$If!vh#v7:V l4:  0,57af4p ytiT$$If!vh#v#v:V lK055aytiTDd:  S A?ünidcr_logoNIDCR - 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