英文版CRF.docx
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英文版CRF.docx
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英文版CRF
英文版CRF
PROTOCOLNUMBER:
“APhaseI,OpenLabel,SingleDose,Dose-EscalationStudyToEvaluatethe
SafetyandTolerabilityofdrugin
HealthyMaleVolunteers”
InvestigatorNo.PatientNo.CohortNo.Patientinitial
____________________________________
-1-
STUDYFLOWCHART/TIMEANDEVENTSSCHEDULE
AssessmentsBaseline24hrsDay3Day7Day14Screening
Day0Day-14Postdosing
InformedConsentXMedicalHistoryXDemographicsXVitalSignsXXXPhysicalExaminationXXXCBCwithdifferentialX
andplateletcountsX
ASerumChemistryXUrinalysisXX
BBloodculture(clinicallyX
indicated)
StoolExamX
ECGXAdministrationofStudyDosing
DrugPer
cohort
C,DDDAdverseEventsXXXXX
A.Sodium,Potassium,BUN,SerumCreatinine,Chloride,Bicarbonate,Calcium,
Phosphorus,Glucose,Bilirubin,ALT,AST,AlkalinePhosphatase,GGT,LDH
oB.Bloodculturewillbedoneifclinicallyindicated,suchasforanyfebrilecase(>101F).
C.AnyAEswillbefolloweduntilsatisfactoryresolutionormedicallystable.
D.Phonecontactwitheachsubjectforadverseevents.
-2-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
InclusionCriteriaandExclusionCriteria
YESNOInclusionCriteria
,1.MaleCaucasiansubjectsaged18-55years;
,2.Wwithoutdocumentedchronicdiseasehistory;
,3.Normalwholebloodcountandurinalysis;
,4.Normalliverandkidneyfunction;
,5.NormalECG;
,6.Withoutmedicationsinthepasttwoweeks;
,7.Abletocomplywiththestudyandfollow-upprocedures;
,8.Written(signed)InformedConsenttoparticipateinthestudy,and;
,9.Withoutparticipationinanyclinicaltrialwithin30days.
AresponseofNOdisqualifiesthesubjectfromparticipationinthestudy
NOYESExclusionCriteria
1.concurrenttreatmentwithfollowingmedicinalagents:
,,Antiacidagents;
,,Antibiotics;
,,Bismithpreparation;
,,Tannicacid;
,,MedicalCharcoal;
,,Tincture.
2.Thestudywillexcludeofhouseholdswithimmunosuppressedpatients,,,foodhandlers,healthcareworks;
3.VolunteersmustbetestednegativeforHIV,HepatitisBandC,andhave,,nohistoryofgastrointestinaldisease.
4.Volunteerswhousedanyprescriptiondrugs,includingantibiotics,with
,14days,orover-the-counterdrugs,includingherbalremedies,with7
dayswillbeexcludedfromthestudy.
5.Administrationofanyinvestigationaltestarticlewithin30dayspriorto,,dosingthestudydrug.
6.Anyconditionthat,inthejudgmentoftheinvestigator,wouldplacea
,subjectatunduerisk,orpotentiallycompromisetheresultsor
interpretationofthestudy.
AresponseofYESdisqualifiesthesubjectfromparticipationinthestudy
-3-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
Demography:
Dateofbirth:
Sex(Markone)
__/__/____
ddmmyyyy,1Male,,2Female
Race/Ethnicity(Markone)
1Asian
2Black/Non-Hispanic
3White/Non-Hispanic
4NativeAmerican
5Hispanic
99Other,specify:
___________________
Productivitystatus
FemaleFertilityStatus:
Females(markone):
1Pre-Menarche,3Post-Menopausal
2Sterile,4Potentiallyabletobearchildren
-4-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
ConcomitantMedications
Areanymedicationsusedatpresent?
1No2Yes,pleaserecordin“ConcomitantMedicationform”
AllergyHistory
Doesthesubjecthaveanyallergyhistory?
1No2Yes,documentbelow
_________________________________________________________________________
_________________________________________________________________________
-5-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
MedicalHistory
AnysignificantSystemBodysystemmedicalhistory?
If“Yes”pleasegivedetailsNo.YesNo
Skin1.1,0,
Head,Eyes,Ears,Nose,throat2.1,0,
Respiratory3.1,0,
Cardiovascular4.1,0,
Gastrointestinal5.1,0,
Endocrine/Metabolic6.1,0,
Genitourinary7.1,0,
Neurological8.1,0,
Blood/Lymphatic9.1,0,
Musculoskeletal10.1,0,
hepatic11.1,0,
Allergies12.1,0,
Psychological/Psychiatric13.1,0,
99.Other,specify:
_____________1,0,
-6-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
ClinicalLaboratoryvalues:
HematologyDateofspecimencollection:
_____/_____/_____
ddmmyyyyReferenceLaboratory:
______________________TimeofspecimenCollection;____:
____
24hr.Clock
IsAbnormalValueUnitResultnotclinicalSignificant?
TestUnit(ifdifferent)availableValue
YesNo
63RBC(x10/mm)___.__1,1,0,
HGB(g/dL)___.__1,1,0,
33Platelets(x10/mm)___.__1,1,0,PLT
HCT(%)___.__1,1,0,
33WBC(x10/mm)___.__1,1,0,
Differential:
___.__1,1,0,Polys(%)
Lymphocytes(%)___.__1,1,0,Segmented(%)___.__1,1,0,Neutrophils
Band(%)___.__1,1,0,Neutrophils
Monocytes(%)___.__1,1,0,Eosinophils(%)___.__1,1,0,Basophils(%)___.__1,1,0,Ifabnormallabvalueisconsideredtobeclinicallysignificant,pleaseindicateonthe
MedicalHistory
-7-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
ClinicalLaboratoryvalues:
BloodChemistryDateofspecimencollection:
_____/_____/_____
ddmmyyyyReferenceLaboratory:
____________________TimeofspecimenCollection;____:
____
UnitUnitResultnotIsAbnormalValue24hr.Clock(ifdifferent)availableValueclinicalSignificant?
TestYesNoCalcium(mg/dL)___.__1,1,0,
Phosphate(mg/dL)___.__1,1,0,
Sodium(mEq/L)___.__1,1,0,Potassium(mEq/L)___.__1,1,0,Chloride(mEq/L)___.__1,1,0,LDH(IU/L)___.__1,1,0,AST(IU/L)___.__1,1,0,Total(mg/dL)___.__1,1,0,Bilirunbin
ALT(IU/L)___.__1,1,0,ALK.(IU/L)___.__1,1,0,Phosphatase
Totalprotein(g/dL)___.__1,1,0,Albumin(g/dL)___.__1,1,0,BUN(mg/dL)___.__1,1,0,Creatine(mg/dL)___.__1,1,0,UricAcid(mg/dL)___.__1,1,0,
Ifabnormallabvalueisconsideredtobeclinicallysignificant,pleaseindicateonthe
MedicalHistory
-8-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
ClinicalLaboratoryvalues:
UrinalysisDateofspecimencollection:
_____/_____/_____
ddmmyyyy
ReferenceLaboratory:
____________________TimeofspecimenCollection;____:
____
24hr.Clock
TestUnitUnitResultnotIsAbnormalValue
(ifdifferent)availableValueclinicalSignificant?
YesNo
Specific(mg/dL)
Gravity___.__1,1,0,
pH(mg/dL)___.__1,1,0,
Color(mEq/L)___.__1,1,0,
Appearance(mEq/L)___.__1,1,0,
Protein(mEq/L)___.__1,1,0,
Glucose(IU/L)___.__1,1,0,
Ketone(IU/L)___.__1,1,0,
Ifabnormallabvalueisconsideredtobeclinicallysignificant,pleaseindicateonthe
MedicalHistory
-9-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
ClinicalLaboratoryvalues:
StoolanalysisDateofspecimencollection:
_____/______/_____
ddmmmyyyy
ReferenceLaboratory:
__________________TimeofspecimenCollection;____:
____
24hr.Clock
Ova/parasite
1,notdone
Dateofassessment:
_____/_______/_____
ddmmmyyyy
Results:
1negative
2Positive
ClostridiaDifficileToxinAssay
1,notdone
Dateofassessment:
_____/_______/_____
ddmmmyyyy
Results:
1negative
2Positive
CultureforEntericpathogens
1,notdone
Dateofassessment:
_____/_______/_____
ddmmmyyyy
Results:
1negative,2PositivePathogenResults
Campylobacter,1negative
2Positive
PathogenicE.Coli,1negative
Salmonella,2Positive
Shigella,1negative
YersinaEnterocolitica,2Positive
Other,1negative
2Positive
-10-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
VitalSigns
Visitdate:
_____/_______/_____
ddmmmyyyy
Temperature:
______.__1,?
C2,?
FBloodpressure:
______/______mmHg
SystolicDiastolic
Pulse:
__________beatsperminHeight:
_________.____1,cm2,in
Respirations:
__________breathsperminWeight:
_________.____1,kg2,Ib
BodysurfaceArea:
___.______m?
12-LeadElectrocardiogram
Wasa12-LeadECGperformed?
1No
2Yes(documentbelow)
DateandtimeofECG:
_____/_______/_________:
____
ddmmmyyyyhhmm
(00:
01-23:
59)
-11-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
PhysicalExam
SystemBodysystemNotOnlySpecifyNormalAbnormalNo.doneAbnormality
Skin1.0,1,97,
Head,Eyes,Ears,Nose,2.0,1,97,throat
Respiratory3.0,1,97,
Cardiovascular4.0,1,97,
Gastrointestinal5.0,1,97,
Endocrine/Metabolic6.0,1,97,
Genitourinary7.0,1,97,
Neurological8.0,1,97,
Blood/Lymphatic9.0,1,97,
Musculoskeletal10.0,1,97,
Neck11.0,1,97,
Breast12.0,1,97,
Pelvic13.0,1,97,
Rectal14.0,1,97,
Other,99.0,1,97,specify:
_____________
-12-
ProtocolNo.InvestigatorNo.CohortNo.PatientNo.PatientinitialVisit
_________Screening
VitalSigns
Visitdate:
_____/_______/_____
ddmmmyyyy
Temperature:
______.__1,?
C2,?
FBloodpressure:
______/______mmHg
SystolicDiastolic
Pulse:
__________beatsperminHeight:
_________.____1,cm2,in
Respirations:
__________breaths
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