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소스 선택 도메인 선택 항목 Site Subject Visit
  • 전체 선택
  • CRF
  • IWRS
  • NonCRF(Audit Trail)
  • NonCRF(Master)
  • NonCRF(Status)
  • REPORT
      • 전체 선택
      • 1A.PM Hospital
      • 1S.TESSA Hospital
      • 1Z.CRSCUBE HOSPITAL
      • 2A.PM Clinic
      • 2Z.TEST02
      • 3Z.TEST03
      • 4Z.Validation
      • 59.P5
      • 5Z.World Hospital
      • 70.PM_0927
      • 71.송도용
      • 72.김민정
      • 73.김민지16
      • 74.윤희남
      • 75.공우석
      • 76.송나경
      • 77.민지아
      • 78.신서란
      • 79.김민지17
      • 7Z.M 테스트기관
      • 80.서예석
      • 81.KHJ
      • 82.TESTHJ
      • 83.TESTHJ2
      • 84.SKH
      • 88.TEST JAMIN
      • 8Z.Intellim
      • 99.Cube Hospital Name Changed
      • 9A.에이디엠코리아병원
      • 9X.CTMS Test
      • AT.AWS 부하 테스트 사이트
      • CA.CRScube America
      • DD.dMED Hospital
      • EB.은별TEST병원
      • HW.Planning&Marketing Dept.1_chw
      • JP.東京大学医学部附属病院
      • JT.JPTEST
      • KT.국립암센터
      • LT.Linical Test
      • M1.MPI Test
      • MJ.北京大学附属医院
      • ST.HISHI
      • TA.TEST
      • US.US test hospital
      • ZA.TEST_IDS_GIS
      • ZZ.TESTS
      • 전체 선택
      • S-1Z-001
      • S-1Z-002
      • S-1Z-003
      • S-1Z-005
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        미리보기
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        Filter Settings
        Filtering DomainFiltering VariableFiltering Visit
        • Select all
        • DG.등록
        • SV.방문일&방문일2&방문일3
        • DM.인구학적 정보
        • MY.병력
        • MH.병력
        • CC.선행/병용약물 확인
        • PE.신체검진
        • VS.활력징후 및 신체계측
        • XR.흉부 X-ray
        • XF.Image Evaluation 1
        • EG.심전도
        • PG.임신 검사
        • LY.실험실적 검사
        • LB.실험실적 검사
        • CX.Central Lab
        • CL.Central Lab
        • FR.Framingham Risk Score
        • IE.선정/제외기준
        • SE.적합성
        • EF.유효성 평가
        • AC.이상반응 확인
        • DA.임상시험용 의약품 투여
        • UY.예정되지 않은 방문
        • UV.예정되지 않은 방문
        • AY.이상반응
        • AE.이상반응
        • CY.선행/병용약물
        • CM.선행/병용약물
        • DS.임상시험 종료
        • SN.시험책임자 서명
        • Select all
        • AE.AETERM(Adverse event)
        • AE.AESDTC(Start Date)
        • AE.AEOUT(Outcome)
        • AE.AEENDTC(End Date)
        • AE.AESER(Serious)
        • AE.AESEV(Severity)
        • AE.AEREL(Relationship)
        • AE.AEACN(Action Taken with Study Treatment)
        • AE.AECONTRT(Medication Treatment)
        • CM.CMTRT(Medication)
        • CM.CMDOSE(Total Daily Dose)
        • CM.CMDOSU(Unit)
        • CM.CMDOSUO(OTHER)
        • CM.CMROUTE(Route)
        • CM.CMROUTEO(OTHER)
        • CM.CMSTDTC(Start Date)
        • CM.CMING(Ongoing)
        • CM.CMENDTC(End date)
        • CM.CMINDC(Indication)
        • CM.CMINDCAE(AE_Other)
        • CM.CMINDCMH(MH_Other)
        • CM.CMINDCO(Other_Other)
        • CM.MPID(WHODD_DM_Medication Product ID)
        • CM.DRNUM(WHODD_DM_Drug Record Number)
        • CM.WHOSEQ1(WHODD_DM_Sequence Number 1)
        • CM.WHOSEQ2(WHODD_DM_Sequence Number 2)
        • CM.DRUGCD(WHODD_DM_Drug Code)
        • CM.DRUGNAM(WHODD_DM_Drug Name)
        • CM.NAMSP(WHODD_DM_Name specifier)
        • CM.DNAMSP(WHODD_DM_Drug Name specifier)
        • CM.INGRE(WHODD_DM_Ingredients)
        • CM.GENYN(WHODD_DM_Generic Y or N)
        • CM.PREFYN(WHODD_DM_Preferred Y or N)
        • CM.CTRCD(WHODD_DM_Country Code)
        • CM.WCOUNTRY(WHODD_DM_Country Name)
        • CM.WHOMAH(WHODD_DM_Marketing Authorization Holder)
        • CM.WHOPFRM(WHODD_DM_Pharmaceutical form)
        • CM.WHODOSE(WHODD_DM_Strength)
        • CM.WHOPNAM(WHODD_DM_Preferred name)
        • CM.WSATCCD(WHODD_DM_Selected ATC Code)
        • CM.WSATCLV1(WHODD_DM_Selected ATC Name Lv1)
        • CM.WSATCLV2(WHODD_DM_Selected ATC Name Lv2)
        • CM.WSATCLV3(WHODD_DM_Selected ATC Name Lv3)
        • CM.WSATCLV4(WHODD_DM_Selected ATC Name Lv4)
        • CM.WHOATCCD(WHODD_DM_ATC Code)
        • CM.WHOATCNM(WHODD_DM_ATC Name)
        • CM.WHODVER(WHODD_DM_Dictionary Version)
        • CM.WHODSVR(WHODD_DM_Dictionary Short Version)
        • CM.WHODCO(WHODD_DM_Comments)
        • DA.DACAT(Study Treatment)
        • DA.DANA(NA)
        • DA.DADIS(Dispensed Amount)
        • DA.DARET(Returned Amount)
        • DA.DAUSE(Used Amount)
        • DA.DAMIS(Missed Amount)
        • DG.DGYN(Was informed consent obtained?)
        • DG.ICDTC(Date of Informed Consent obtained)
        • DM.BRTHDTC(Birth Date)
        • DM.AGE(Age)
        • DM.SEX(Sex)
        • DM.DEMO_4_Y(체크박스 테스트 Y)
        • DM.DEMO_4_N(체크박스 테스트 N)
        • DS.EXSTDTC(First date of IP administration)
        • DS.EXENDTC(Last date of IP administration)
        • DS.DSYN(Did subject complete trial?)
        • DS.DSDTC(Stop date)
        • DS.DSREA(Reason for Withdrawn)
        • EF.EFRS(Satisfaction of CRScube System)
        • EG.EGND(ND)
        • EG.EGDTC(Date of Test)
        • EG.EGYN(Was the new ECG result clinically significant after last visit?)
        • IE.IN01(1. Subject who signed on informed consent.)
        • IE.IN02(2. Subject whose age is equal to or greater than 20, and less than 80 years old.)
        • IE.IN03(3. Subject whose serum glucose is less than 200 mg/dL)
        • IE.IN04(4. Subject without anti-diabetic treatment within 3 months.)
        • IE.IN05(5. Subject without cardiac disease)
        • IE.EX01(1. Subject who is pregnant.)
        • IE.EX02(2. Subject who participated in other trial within 30 days)
        • IE.EX03(3. In the opinion of the investigator, Subject who is unsuitable for the study.)
        • IE.EX04(4. Subject who has any condition of BMI>=25kg/m2 or Total Cholesterol>=UNL*2 or CHD 10 year risk>=20%)
        • LB.LBTEST(Test Name)
        • LB.LBORRES(Outcome)
        • LB.LBNOR(Normality)
        • LB.LBCS(Clinical Significance)
        • MH.MHTERM(Disease/Surgery)
        • MH.MHING(Ongoing on screening)
        • PG.PGYN(Was pregnancy test performed?)
        • PG.PGDTC(Date of Test)
        • PG.PGRE(Test Result)
        • SE.SEYN(Is the subject eligible to participate to participate in the study?)
        • SE.SEREA(Reason for NOT eligible)
        • SN.SNSIGN(SIGNATURE)
        • SN.SNDTC(Date of signature)
        • SV.SVDTC(VISIT DATE)
        • UV.UVDTC(VISIT DATE)
        • UV.UVREA(Reason for Visit)
        • UV.UVREACO(Other Specify)
        • UV.UVCOM(Comments)
        • VS.VSND(ND)
        • VS.SBP(Systolic Blood Pressure)
        • VS.DBP(Diastolic Blood Pressure)
        • VS.HR(Pulse)
        • VS.RR(Respiratory Rate)
        • VS.BT(Temperature)
        • VS.WT(Weight)
        • VS.HT(Height)
        • XR.XRND(ND)
        • XR.XRDTC(Date of Test)
        • XR.XRYN(Was the Chest X-ray result clinically significant?)
        • XR.XRUPLOAD(File Upload)
        • AC.ACYN(Is there any newly occurred AE since last visit?)
        • CC.CMYN(Is there any new medication?)
        • AY.AENONE(None)
        • CY.CMNONE(None)
        • LY.LBND(ND)
        • LY.LBDTC(Collection Date)
        • MY.MHNONE(None)
        • PE.PEYN(Was the new physical examination result clinically significant after last visit?)
        • UY.UVNONE(None)
        • CX.CLND(ND)
        • CX.CLDTC(Collection Date)
        • CL.CLTEST(Test Name)
        • CL.CLORRES(Outcome)
        • CL.CLNOR(Normality)
        • CL.CLCS(Clinical Significance)
        • FR.FRAGE(Age)
        • FR.FRTC(Total Cholesterol(mg/dL))
        • FR.FRSMOKE(Smoke)
        • FR.FRHDL(HDL Cholesterol(mg/dL))
        • FR.FRSBP(SBP(mmHg))
        • FR.FRHTTRT(Hypertension Treatment)
        • FR.FRYSCORE(CHD 10 years risk)
        • FR.FRRISK(Risk Group)
        • XF.XFFILE(File Download)
        • XF.XFEVAL(Image Evaluation)
        • Select all
        • 0.ENROL
        • 1.Cycle Label - V1
        • 1001.IE
        • 2.V2
        • 3.V3
        • 4.V4
        • 2001.Unscheduled Visit 1
        • 2002.Unscheduled Visit 2
        • 2003.Unscheduled Visit 3
        • 2004.Unscheduled Visit 4
        • 2005.Unscheduled Visit 5
        • 2006.Unscheduled Visit 6
        • 2007.Unscheduled Visit 7
        • 2008.Unscheduled Visit 8
        • 4001.임상시헝용 의약품 투여
        • 4002.UNSCHEDULED VISIT
        • 4004.ADVERSE EVENT
        • 4007.Survey for subjects
        • 4003.PRIOR/CONCOMITANT MEDICATION
        • 4008.Survey for guardians
        • 4005.End of Trial
        • 4006.SIGNATURE
        AuditTrail Date : ~
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