Case Report Form - University Of Leicester

Case Report FormSTUDY TITLEChief / Principal Investigator:CRF Version Number: V//20UoL Reference Number:UHL/CRN Reference Number:Subject ID Number:Subject Initials:Sponsor:University of LeicesterResearch Governance OfficeResearch & Enterprise DivisionFielding Johnson BuildingUniversity RoadLeicesterLE1 7RHENTER SHORT STUDY TITLECase Report Form Template– Appendix 1 to SOP S-1039, v2, Nov 2016Page 1 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Demographic DataDate of BirthDEthnicityWhite Mixed RaceWhite BritishWhite & BlackCaribbeanAsian or AsianBritishIndian Black or BlackBritishChinese or otherethnicityCaribbeanChineseGenderCompleted by:White IrishWhite & BlackAfricanD MMYYWhite & Asian Pakistani Black Other White OtherBangladeshi African Other (please specify)MaleSignature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Other mixedbackgroundOther AsianbackgroundFemaleDate:Page 2 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Informed Consent ProcessInformed Consent ProcessDate & Timesubject/relative/witness givenParticipant Information SheetDateTimeDDate & Timesubject/relative/witness signedWritten Consent FormDMYYHDateHMMHMMTimeDDate & Version Number ofParticipant Information Sheetconsented toName of person takingInformed ConsentMDMMYHYDateDDMMYYVersionv NameHas a copy of the signedconsent form/participantinformation sheet been given tothe subject?Yes No Yes At time of consentPosted to subjectDate postedDHas a copy of the signedconsent form/participantinformation sheet been filed inthe medical notes?Has a written entry detailingthe consent process been madein the main body of the medicalnotes?Completed by:Yes No Yes No No YesDNoMMYYIf not please explain .If not please explain . .If not please explain . Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 3 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Inclusion CriteriaDate of AssessmentDDMMYYInclusion Criteria1.INSERT INCLUSION CRITERIA AS PER PROTOCOL2.3.4.5.6.7.8.9.10.YESNON/A If any of the above criteria is answered NO, the subject is not eligible for the trial and must not be included in thestudy.Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 4 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Exclusion CriteriaDate of AssessmentDDMMYYExclusion Criteria1.INSERT EXCLUSION CRITERIA AS PER PROTOCOL2.3.4.5.6.7.8.9.10.YESNO If any of the above criteria is answered YES, the subject is not eligible for the trial and must not be included inthe study.Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 5 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Medical HistoryMedical HistoryHas the subject had any relevant medical history?No Yes complete belowIf not please explain . Date of AssessmentDCondition/Illness / Surgical ProcedureCompleted by:DMMYStart Date(DD/MM/YYYY)/ /Stop Date(DD/MM/YYYY)/ // // // // // // // // // // // // // // // // // // // // // // // // /Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016YOR tick if on goingat screening visit Date:Page 6 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Physical ExaminationPhysical ExaminationWas a physical examination performed?No Yes complete belowIf not please explain . .Date of examinationDSystemGeneral AppearanceSkinEyes, Ears, Nose &ThroatHead, Neck & GenitaliaAnorectalLymph NodesMuscular-SkeletalNeurologicalOthers (please specify)*AbnormalNormalNot Done Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016DMMYYif ABNORMAL, please provide brief descriptionand record if clinically significant or not(CS/NCS)Date:Page 7 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Vital Signs & ECGVital Signs & ECGWere vital signs performed? NoYes complete belowIf not please explain . .Date of Vital SignsDDMHMMYYTime of Vital SignsHBlood Pressure gTemperature. cHeight.mWas an ECG performed? No Yes complete below If not please explain . .Date ECG performedDDMMYYTime ECG performedHThe ECG is Within normal limits Abnormal, NOT clinically significantHMM Abnormal, Clinically Significant, please specify: . .Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 8 of 26

Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 9 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 (SCREENING) HaematologyHaematologyClinical Haematology Laboratory tests performed?No Yes complete belowIf not please explain . .Date of SampleDDHHMMYYTime of SampleHaematologyValueUnitWBCMIf indicated as out of normal range onreport, please state if NoBASOPHILSNoRETICULOCYTESCompleted by:MNoSignature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016 YesYesYesYesYesYesYesYesYesYesYesYesYes Date:Page 10 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING BiochemistryBiochemistryClinical Biochemistry Laboratory tests performed?No Yes complete belowIf not please explain . .Date of SampleDDHHMMYYTime of SampleBiochemistryValueUnitSODIUMMIf indicated as out of normal range onreport, please state if ONATENoUREANoCREATININENoTOTAL PROTEINNoTOTAL BILIRUBINNoALBUMINNoALK PHOSNoALTNoASTNoCALCIUMCompleted by:MNoSignature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016 YesYesYesYesYesYesYesYesYesYesYesYesYes Date:Page 11 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Insert AssessmentINSERT ASSESSMENTClinical INSERT ASSESSMENT Laboratory testsperformed?No Yes complete belowIf not please explain . .Date of SampleDDHHMMYYTime of SampleINVESTIGATOR TOINSERT OTHERASSESSMENTValueUnitMMIf indicated as out of normal range onreport, please state if pleted by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016 YesYesYesYesYesYesYesYesYesYesYesYesYes Date:Page 12 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Screening Concomitant MedicationConcomitant MedicationsDate of AssessmentDDMMYIs the subject taking any concomitant medications?MedicationReason foruseDose &UnitsFrequencyNoRouteY Start Date(DD/MM/YYYY)Yes complete belowStop Date(DD/MM/YYYY)OR tick if ongoing attime ////////////////2.3.4.5.6.7.8.9.10.11.12.Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 13 of 26

Subject ID:Subject Initials:Visit Date:DVISIT 1 SCREENINGDMMYSmoking / AlcoholDate of AssessmentDSmoking / AlcoholHas the subject ever smoked? Current Smoker NoYes MMYYcomplete belowSubject’s average daily use:Number smoked per daySmoked forFormer Smoker Dmonths / yearsDate when smoking ceasedDDMMYYParticipants alcohol consumptionWineunits per week / monthBeerunits per week / monthSpiritsunits per week / monthCompleted by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 14 of 26Y

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Subject Eligibility ReviewDate of AssessmentDDMMYYParticipant Eligibility Review1.Does the subject satisfy the inclusion/exclusion criteria?2.Have the medical history and concomitant medication pages beencompleted?Is the subject still willing to proceed in the trial?3.Subject’s eligibility Investigator sign-offIs the subject eligible to take part in the Clinical Trial?YESNO YESPrincipal Investigator’s (or delegated individual*) Signature:Date: NO Please give reason below/ / (DD/MM/YYYY)Investigator’s Name:*Must be reflected in the Delegation of Authority LogReason(s) for screen failure1.2.3.Subject Randomisation/EnrolmentSubject Study Number AllocatedSubject IDDate of Randomisation/EnrolmentDCompleted by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016DMMYYDate:Page 15 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT 1 SCREENING Investigational Medicinal ProductDate of AssessmentDDMMYYInvestigational Medicinal Product1.2.YESNOHas the subject been issued with the TrialMedication as per protocol? Has the subject received instruction /guidance on how to take the TrialMedication? RandomisationSubject randomised to:Completed by:If NOT explain If NOT explainArm INSERT AS PER PROTOCOL Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Arm INSERT AS PER PROTOCOL Date:Page 16 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT INSERT VISIT NAME OR NUMBER AS PER PROTOCOL ChecklistVisit Checklist1.2.3.Did the subject experience any new or changes to existing adverse events since thescreening visit/previous visit? If YES, please complete adverse event page(If an AE is marked as serious this must be reported to the Sponsor within 24 hours ofthe research team being made aware of the event, utilising the Sponsor SAE form as perSponsor SOP S-1009)Have there been any changes to existing medication, or the subject has taken anynew medication since the screening visit/previous visit? If YES, please completeconcomitant medication pageINVESTIGATOR TO ADD OTHER REQUIRED ASSESSMENTS AS PER PROTOCOL4.Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016YESNO Date:Page 17 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT INSERT VISIT NAME OR NUMBER AS PER PROTOCOL Physical ExaminationPhysical ExaminationWas a physical examination performed?No Yes complete belowIf not please explain . .Date of examinationDSystemGeneral AppearanceSkinEyes, Ears, Nose &ThroatHead, Neck & GenitaliaAnorectalLymph NodesMuscular-SkeletalNeurologicalOthers (please specify)*AbnormalNormalNot Done Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016DMMYY*if noted ABNORMAL, please provide briefdescription and comment if clinicallysignificant or not (CS/NCS)Date:Page 18 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT INSERT VISIT NAME OR NUMBER AS PER PROTOCOL Vital SignsVital Signs & ECGWere vital signs performed? NoYes complete belowIf not please explain . .Date of Vital SignsDDMHMMYYTime of Vital SignsHBlood Pressure gTemperature. cHeight.mWas an ECG performed? No Yes complete below If not please explain . .Date ECG performedDDMMYYTime ECG performedHThe ECG is Within normal limits Abnormal, NOT clinically significantHMM Abnormal, Clinically Significant, please specify: . .Completed by:Signature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016Date:Page 19 of 26

Subject ID:Subject Initials:Visit Date:DDMMYYVISIT INSERT VISIT NAME OR NUMBER AS PER PROTOCOL HaematologyHaematologyClinical Haematology Laboratory tests performed?No Yes complete belowIf not please explain . .Date of SampleDDHHMMYYTime of SampleHaematologyValueUnitWBCMIf indicated as out of normal range onreport, please state if NoBASOPHILSNoRETICULOCYTESCompleted by:MNoSignature:ENTER SHORT STUDY TITLECase Report Form Template – Appendix 1 to SOP S-1039, v2, Nov 2016 YesYesYesYesYesYesYesYesYesYesYesYesYes Date:Page 20 of 26