英文版CRF文档格式.docx

英文版CRF文档格式.docx

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A.Sodium,Potassium,BUN,SerumCreatinine,Chloride,Bicarbonate,Calcium,

Phosphorus,Glucose,Bilirubin,ALT,AST,AlkalinePhosphatase,GGT,LDH

oB.Bloodculturewillbedoneifclinicallyindicated,suchasforanyfebrilecase（>

101F）.

C.AnyAEswillbefolloweduntilsatisfactoryresolutionormedicallystable.

D.Phonecontactwitheachsubjectforadverseevents.

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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

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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

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ConcomitantMedications

Areanymedicationsusedatpresent?

1No2Yes,pleaserecordin“ConcomitantMedicationform”

AllergyHistory

Doesthesubjecthaveanyallergyhistory?

1No2Yes,documentbelow

_________________________________________________________________________

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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,

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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

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BloodChemistryDateofspecimencollection:

____________________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

-8-

UrinalysisDateofspecimencollection:

ddmmyyyy

ReferenceLaboratory:

TestUnitUnitResultnotIsAbnormalValue

（ifdifferent）availableValueclinicalSignificant?

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,

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StoolanalysisDateofspecimencollection:

_____/______/_____

ddmmmyyyy

__________________TimeofspecimenCollection;

Ova/parasite

1,notdone

Dateofassessment:

_____/_______/_____

Results:

1negative

2Positive

ClostridiaDifficileToxinAssay

CultureforEntericpathogens

1negative,2PositivePathogenResults

Campylobacter,1negative

PathogenicE.Coli,1negative

Salmonella,2Positive

Shigella,1negative

YersinaEnterocolitica,2Positive

Other,1negative

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VitalSigns

Visitdate:

_____/_______/_____

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）

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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:

_____________

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__________breaths