ࡱ> wytuv %bjbjHH 6*j*j5 8t0(==={{{///////25/{YY"{{/==/ {R==/ {/ r,T- =LmMo^r,//00,?6+?6*-?6*-h{{ {{{{{// {{{0{{{{?6{{{{{{{{{ :  Source Document List Sponsor Trial Reference:Site:Principal Investigator:Version no: Examples added in italics below review and delete before finalising * These items may not be delete/amended ** note if paper, electronic or with the aid of a worksheet Name of assessment -delete/revise/add according to your study specific needs Responsible Team to ensure source information is recorded/ uploaded/ filed/printed in place Output/Content of Source Document- revise according to your study specific needs Type of Source Document- select as applicable: Medical records in hospital- please specify if in Cerner or other type of medical records. Source worksheets/paper CRFs- please specify if needed and cannot/will not be captured in medical records.  Location of Source Document (physical department/ electronic location) 1Informed Consent* Trial staffInformed Consent form A copy of the signed consent form/s to be filed in Investigator site file and patients medical records 2Informed Consent ProcedureTrial staffRecord of consent procedureMedical records in hospital, source worksheets/paper CRFs3Inclusion and exclusion criteria*Trial staffInclusion/exclusion checklist Medical records in hospital, source worksheets/paper CRFs4Confirmation of eligibility* Trial staffConfirmation of eligibility signed by relevant investigator Medical records in hospital, source worksheets/paper CRFs5Date of study visit Trial staff Date of Visit and number/type of visit to be recorded Medical records in hospital, source worksheets/paper CRFs6Dates of inpatient careTrial staffMedical records in hospital source worksheets/paper CRFs7Demographic dataTrial staffMedical records in hospital, source sheets/paper CRFs8Smoking/Alcohol HistoryTrial staffMedical records in hospital, source worksheets/paper CRFs9Medical HistoryTrial staffMedical records in hospital, source worksheets/paper CRFs 10Physical examinationTrial staffMedical records in hospital, source worksheets/paper CRFs11Vital signs: blood pressure/heart rateTrial staffMedical records in hospital, Source worksheets/paper CRFs12Oral temperature  Trial staffMedical records in hospital, source worksheets/paper CRFs13WeightTrial staffMedical records in hospital, source worksheets/paper CRFs14HeightTrial staffMedical records in hospital, source worksheets/paper CRFs15Pregnancy test (urine or serum) Trial staff Lab report Medical records in hospital, source worksheets/paper CRFs16Haematology Trial staffLab report Medical records in hospital, source worksheets/paper CRFs17Biochemistry Trial staff Lab report Medical records in hospital, source worksheets/paper CRFs18Urinalysis: Urea &ElectrolytesTrial staffLab report Medical records in hospital, source worksheets/paper CRFs19Virology Trial staffLab report Medical records in hospital, source worksheets/paper CRFs20 X-rayTrial staffX-ray report Medical records in hospital, source worksheets/paper CRFs21ECGTrial staffECG output in Medical noteMedical records in hospital, source worksheets/paper CRFs22Bone chemistryTrial staffLab report 23Chimerism samplesTrial staffLab report 24Tissue typingTrial staffLab report Medical records in hospital, source worksheets/paper CRFs25Donor Venesection Trial staffMedical records in hospital, source worksheets/paper CRFs26Disease status at transplantTrial staffMedical records in hospital, source worksheets/paper CRFs27Transplant conditioning chemotherapyTrial staffDrug chart/ Chemocare systemMedical records in hospital, source worksheets/paper CRFs28Concomitant medicationTrial staffDrug chart/log including start & end date/ongoingMedical records in hospital, source worksheets/paper CRFs29IMP administration: Start & Stop time, Dose and volume of IMP, Trial staffMedical records in hospital, source worksheets/paper CRFs30PCRTrial staffLab report 31Research sample analysis: specify name of samples Trial staffLab reportsMedical records in hospital, source worksheets/paper CRFs32PK samples: date, time volumeTrial staff33PK results:Trial staff34Adverse eventsTrial staffAdverse event log including categories, start & end date/ongoingMedical records in hospital, source worksheets/paper CRFs35Date of Last Visit Trial staffMedical records in hospital, source worksheets/paper CRFs36Trial Completion StatusTrial staffConfirmation of end date and reason (study completed, participant withdrawn consent, investigator withdrawn participant) Medical records in hospital, source worksheets/paper CRFs Principal Investigator: RGIT Monitor:Signature:  Signature: Date: Date:       RGIT_TEMP_088 Source Document List Template, V3.0 17 Dec 2025 Page  PAGE \* Arabic \* MERGEFORMAT 4 of  NUMPAGES \* Arabic \* MERGEFORMAT 4 *356<=>VWbcdefϾtp^L:L#hL`hL`6CJOJQJ^JaJ#hL`h06CJOJQJ^JaJ#hL`h#6CJOJQJ^JaJh#!h85CJOJPJQJ^JaJ'h ?h85CJOJPJQJ^JaJ!hvH5CJOJPJQJ^JaJ'h ?h#5CJOJPJQJ^JaJ h'(5CJOJQJ\^JaJhL`hF5OJQJ\^J&h=h!v55CJ OJQJ\^JaJ hW5OJQJ\^J56<= $Ifgdf $IfgdD$a$gd!v5gdW=>VW& $IfgdDkd$$Ifl44\Lz] 4.    t(0444 laf4p(yt'XWcdekd($$Ifl44\Lz] 4. &  t(0444 laf4p(yt8 $IfgdDef   % _ ` l    ? @ * + $$Ifa$gdf | $$Ifa$gd ?    $ % X ^ _ ` l m p q  ϾtcccOOO'hlh_d5CJOJPJQJ^JaJ!h}v5CJOJPJQJ^JaJ'hL`ht5CJOJPJQJ^JaJ!ht5CJOJPJQJ^JaJ!h_d5CJOJPJQJ^JaJ'hL`h_d5CJOJPJQJ^JaJ hL`hkWCJOJQJ^JaJ#hL`h6CJOJQJ^JaJh6CJOJQJ^JaJh06CJOJQJ^JaJ     ' ? @   ( * + A V W X Y ɵn]LLLLLL!h='5CJOJPJQJ^JaJ!hf |5CJOJPJQJ^JaJ!h] CJOJPJQJ\^JaJ!h`UCJOJPJQJ\^JaJ!h,"CJOJPJQJ\^JaJ'h,"htCJOJPJQJ\^JaJ'h,"h_dCJOJPJQJ\^JaJ!h,"5CJOJPJQJ^JaJ'hL`h_d5CJOJPJQJ^JaJ!h_d5CJOJPJQJ^JaJ+ A W X Y Z \ o { $Ifgd414 $$Ifa$gdY^ $Ifgd Ff $$Ifa$gdf | Y Z \ o {  & B ` a ~   , - 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