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IT 1) CDISC CDISC CDISC 2) IT IT IT EDC(Electronic Data Capture) EDC EDC 3) SDVSource Data Verification() 3
IT 4) IT IT EDC CDISC IT EDC CDISC EDC CDISC 1 CDISC IT 3.2 3.2.1 IT IT IT 3.4.2 4
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IT Quintiles CRO CDISC ARO(Academic Research Organization) CDISC 3.5.3 4 2 FDADuke CRO Quintiles Transnational SAS CDISC FDA 2004 7 21 CDISC SDTMStudy Data Tabulation Model CDISC SDTM 1) B-1 CDISC SDTM CDISC CDISC 2) FDANCI B-2 CDISC FDA CDISC FDA FDA FDA FDA 6
IT FDA CDISC CDISC SDTM FDA FDA CDISC FDA CDISC CDSIC CDISC 3) Duke B-3 Duke CDISC CDMS CDISC CDISC Duke Quintiles SAS CDISC SAS 4) Quintiles B-4 CDISC CDISC Quintiles CDISC CDISC CDISC CDISC CDISC SAS CDISC CDISC LAB 3 CRO LAB Quintiles LAB 5) SAS B-5 SAS FDA 7
IT SAS SAS XPT CDISC SAS CDISC SAS CDISC Duke SAS CDISC CDISC SAS SAS CDISC SAS CDISC SAS 3.6 3.6.1 IT CDISC 3.6.2 1) CDISC C 2) CDISC C 3) CDISC C 4) CRO CDISC C 3.6.3 1) CDISC C-1 CDISC CDISC CDISC FDA CRO CDISC FDA 8
IT 1990 FDA PDF SAS XPT CDISC FDA FDA FDA CDISC CRO FDA FDA FDA CDISC FDA CDISC CDISC CRO CDISC 2) CDISC 18 validatorsas Oracle Clinical CDISC CDISC ODMSDTM CDISC ODMSDTM 3) CDISC CDISC (1) CDISC (2)CDISC (3)CDISC 9
IT (4) CDISC 3000 15-20 3000 15-20 8000 40-50 CDISC 3000 15-20 3000 15-20 2000 15-20 2000 15-20 4)CRO CDMS CDISC ClinitrialOracle Clinical ClinitrialOracle Clinical CDISC MS-Office CRO CDMS CDISC 1) CDMS CDISC 10
IT 2) Clinitrial Oracle Clinical MS-Office IT CDISC IT FDA CDISC CDISC CDISC 11
IT CRO CDISC CDISC CDISC IT CDISC CRO IT CDISC IT IT CRC IT IT CDISC IT IT EDC CDISC IT IT 12
IT IT CCT-IT-1701 CDISC CDISC HL7 SDTM FDA CDISC CRO IT 13
IT PubMed Google ( www.google.co.jp www.google.com) AND AND AND ( OR ) Standard AND clinical AND exchange AND (information OR data) PubMed 31 Google 244,000 (2006 2 10 ) 1) (SGML ) 2) J-MIX 3) MERIT-9 4) MML 5) JAHIS 6) HELICS 7) 8) 9) MedDRA/J 14
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IT Quality Control Quality Assurance HIS HIS SGML (SGML ) ( 33(2): 325S-326S, 2002) 3.1.2 J-MIX (http://www.medis.or.jp/4_hyojyun/dataset/index.html) J-MIX the Japanese Set of Identifiers for Medical Record Information Exchange (MEDIS-DC) XML 3.1.3 MERIT-9 (http://merit-9.mi.hama-med.ac.jp) MEdical Record, Image, Text, - Information exchange 1 1999 2002 16
IT J-MIX HL7 RIM HL7 CDA R2 V3 XML-DTD HL7 DICOMJPEG DB 17 3.1.4 MML (http://www.medxml.net) MML Medical Markup Language MML: Medical Markup LanguageMML XML MML XML MML MML 1995 5 Seagaia Meeting1996 2000 NPO MedXML Vesion3 Version3 HL7 Version3 Standard Clinical Document Architecture (CDA) HL7 Version3 CDA (granularity) MERIT-9 MML 3.1.5 JAHIS (http://www.jahis.jp/index.html) JAHIS (Japanese Association of Healthcare Information Systems Industry)JAHIS 6 (1994 ) 10 (1998 ) 17
IT 18 2 339 JAHIS JAHIS JAHIS 10 Web 3.1.6 HELICS (http://helics.umin.ac.jp/) HELICS Board (Health Information and Communication Standards Board) JAHIS (HOT ) JAHIS 8 Web 3.1.7 (http://www.info.pmda.go.jp/) ICH E2b/M2( ) 15 (2003 ) 2005 (http://hanyous.mhlw.go.jp/shinsei/crn/servlet/crntetsuzukiservlet?eventcd=egov&t etsuzukiid=14493) ID HOSPnet UMIN ( University hospital Medical Information Network) UMIN FAX ICH E2b/M2 200 SGML FD CD-ROM 70% 18
IT 15 (2003 )11 ICH MedDRA/J J ICH E2b/M2 URL 3.1.8 (ICMJE http://www.icmje.org/clin_trial.pdf (WHO technical consultation on clinical registration standards meeting http://www.who.int/ictrp/news/ictrp_sag_meeting_april2005_conclusions.pdf) ( https://dbcentre2.jmacct.med.or.jp/ctrialr/) (JAPIC http://www.clinicaltrials.jp/user/cte_main.jsp) (UMIN-CTR http://www.umin.ac.jp/ctr/index-j.htm) 16 (2004 )9 (ICMJE International Committee of Medical Journal Editors) BMJ 11 17 (2005 )7 1 (IFPMAInternational Federation of Pharmaceutical Manufacturers & Associations) WHO() 17 (2005 )4 WHO technical consultation on clinical registration standards meeting (Unique trial number) (Secondary IDs) (Title of the study (Brief title)) (Official scientific title of the study) (Condition) (Intervention(s)) (Primary outcome) (Key secondary outcome) (Key inclusion and exclusion criteria) (Study type)(trial registration date) (Anticipated trial start date) (Target sample size) (Research ethics review) (Funding source(s)) (Primary sponsor) )Secondary sponsor(s)) (Responsible contact person) (Research contact person) (Recruitment status) 19
IT UMIN 16 (2004 ) UMIN-CTR 17 (2005 )6 1 2005 7 1 JAPIC) JapicCTI) 2006 UMINJAPIC 3 UMIN-CTRJapicCTI 3.1.9 (http://www2.medis.or.jp/stdcd/byoumei/index.html) (MEDIS-DC) ICD10 11 (1999 )4 1 13 (2001 ) 14 (2002 )6 2 2 14 (2002 )4 19 MEDIS-DC 3 CD-ROM Version2.43 MedDRA/J (http://www.sjp.jp/~jmo_new2006/) MedDRA(Medical Dictionary for Regulatory Activities Terminology MedDRA 11 (1999 )12 ( ) MedDRA CD-ROM MedDRA/J 12 ASCII 6 20
IT /JLAC10 (http://www.medis.or.jp/4_hyojyun/download/index.html) (JLAC10www.jscp.org/JLAC10/index.htm) JLAC10 38 (1963 ) 61 (1986 ) 2 (1990 ) JLAC10 17 (2005 )11 JLAC10 Ver. 10.a07 JLAC10 LOINC JLAC10 (5 )(3 ) (3 )(4 )(2 ) 17 6 MEDIS-DC JLAC10 MEDIS-DC JLAC10 15 9 Version0.91 JLAC10 MEDIS-DC JAHIS 2 /JLAC10 (MEDIS-DC Web ) (HOT ) 21
IT (http://www.medis.or.jp/4_hyojyun/download/index.html) (MEDIS-DC) 1) 2) 3) 4) HOT HOT 1)2) 3) 4) 1)2) 3) 13 (1) CD(2) (3) (4) 32 Google 17,500,000 (2006 2 10 ) 1) CDISC 2) HL7 3) ICH ectd 4) ICH E2b/M2 (Recommendation Notebook) 5) ISO TC215 6) DICOM 7) SNOMED-CT MedDRA LOINC 22
IT ICH M5 3.2.1 CDISC (www.cdisc.org) CDISC Clinical Data Interchange Standards Consortium FDA HL7 CDISC CDISC 1997 2000 2 CRO2001 2003 1 (JCG) Interchange CDISC ODM(Operational Data Model) Lab (Laboratory Data Model) SDS(Submission Data Standards) SEND (Standard for Exchange of Non-clinical Data) ADaM (Analysis Data Modeling) Terminology Protocol Representation ODM XML FDA 21CFR Part11 LAB CDISC LOINC LAB ASCIISASXMLHL7Ver3 SDS Case Report Tabulation (CRT) SDS Study Data Tabulation Model (SDTM) Version 3.11SDTM ectd FDA ADaM 3 3.2.2 HL7 (http://www.hl7.org/) HL7 Health Level Seven 1987 20 2000 1998 23
IT 3. CDISC ISO ANSI EHR(Electric Health Record) HL7 ISO-OSI 7 Version 2.x () 3 3 () ID PID001 1950 11 27 PID PID OPC-001 PID001 ^ ^^^^^D^I~ ^ ^^^^^D^P~NIHON^Tarou^^^^^D^A 19501127 M<cr> Version3 Version 2.x (Unified Modeling Language : UML) RIM (Reference Information Model) HL7 XML 24
IT CDA(Clinical Document Architecture) Release2.0 CDA Hl7 Version3 CDISC 3..3 ICH ectd (http://estri.ich.org/ectd/) ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use EU ICH EU WHO ectd Electronic Common Technical Document Common Technical Document ectd CTD QualityEfficacy Safety 3 M4 2001 6 M2 2002 9 ectd () CTD 2 ( 2) 5 ( 5) 1 XML DTD(Version3) ectd CDISC 4.CTD 25
IT 3.2.4 ICH E2b/M2 (Recommendation Notebook) (http://estri.ich.org/icsr/) ICH E2b (ICSRIndividual Case Safety Report) 1997 M2 2001 200 SGML 2000 EU 2001 12 2003 10 2001 EU E2b 2003 2006 E2b/M2 M2 2005 5 Recommendation Notebook ver. 3.0 Recommendation Notebook XML E2b SGML XML 3.2.5 ISO TC215 (http://www.iso.ch/) ISO International Organization for Standardization 1947 JISC() TC(Technical Committee) Health Informatics TC215 1998 ANSI WGWG1 Data structurewg2 Data interchangewg3 Semantic contentwg4 SecurityWG5 Health cardswg6 Pharmacy and medicines businesswg7 DevicesWG8 Business requirements for Electronic Health Records 2 3.2.6 DICOM (http://medical.nema.org/dicom/2004html) Digital Imaging and Communications in Medicine 1980 The American College of Radiology (ACR) The National Electronic Manufactures Association (NEMA) () PACS(Picturearchiving and communication systems) 2004 26
IT DICOM 3.2.7 SNOMED-CT (http://www.snomed.org/) SNOMED Systematized Nomenclature of Medicine (CAP:The College of American Pathologists) 34 1965 (SNOP:Systematized Nomenclature of Pathology)1974 SNOMED 2002 NHS(National Health Service) Clinical Terms Version 3(ReadCode) SNOMED-CT (Clinical Terms) 1 2003 7 NLM 3240 5 SNOMED-CT Core Content US Drug Extension NLM UMLS SNOMED-CT SNOMED-CT (Fully Specified Name)(Preferred)(Synonym) 3 SNOMED CT Concept MedDRA (http://meddramsso.com/mssoweb/index.htm) MedDRA(Medical Dictionary for Regulatory Activities Terminology)ICH M1 1997 SOCHLGT HLTPT LLT 5 5 8 Tree MedDRA ICH MSSOMaintenance and Support Service Organization 2 2006 3 Version9.0 WHO-ART(Adverse Reaction Terminology) J-ART( WHO-ART)ICD-9 ICD-10 MSSO JMO Change request 27
IT SOC10021881 HLGT10047438 HLT 10019972 Pt 10019958 LLT: 10011019 LLT: 10019945 LLT: 10019955 LLT: 10023334 HLT 10030045 HLGT: 10021877 SOC10015919 5. MedDRA SNOMED-CT National Cancer Institute CTC-AE(Common Terminology Criteria for Adverse Event) LOINC (http://www.regenstrief.org/loinc/) Laboratory Observation Indetifier Names and Codes Logical Observations Identifiers Names & Codes 1994 1995 Regenstrief Institute Version2.16 2005 12 13 ID HbA1c CPT 83036 LOINC 4548-4 4549-2 17855-8 17856-6 RELMA 6RELMA LOINC 28
IT ICH M5 (http://www.ich.org/cache/compo/2196-272-1html#m5) ICH M5 2003 11 ICH E2b M2 ICH M5 EU 2005 5 2006 (MedID) (PhPID)MedID ID -- JP-123456789-Y JAN HOT NDC PhPID Pharmaceutical Product Identifier ID 4 PhPID1 PhPID2 PhPID3 PhPID4 (Controlled Vocabulary) DRG DPC CDISC CDISC HL7 SDTM FDA V2 SGML CDISC 10 29
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IT CDISC CDISC HL7 SDTM FDA HL7 CDISC 31
IT IT CCT-IT-1701 EDC(Electronic Data Capture) EDC EDC 32
IT A 3. 31 AA AA A A-1 33
IT 32 Electronic Data Capture(EDC) Electronic Data Capture EDC EDC Web Web Web URL EDC EDC ID EDC CRF 34
IT EDC EDC CRF EDC EDC EDC 2000 1 EDC EDC EDC CRC 3 35
IT 1 CDISC FDA CDISC 36
IT CDISC CRO CDISC 1 2 37
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IT FDA CDISC CRO CDISC CDISC CDISC CDISC CDISC CDMS EDC CRO EDCCDMS CDISC EDC CRO(Clinical Research Organization) CDMS: Clinical Data Management System EDC(Electronic Data Capture) CDMS CDISC EDC 3.1 3.1.1 CRO 46
IT (CRF: Case Record Form) EDC 3.1.2 3.1.2.1 CRF 3.1.1.2 400 11.7% 2.6% HL7 HL7 version 2.x version 3.x version 3.x version 3.x 200 SDV(Source Data Verification) 3.1.2.3 47
IT CRF CDISC 3.1.3 CRO CRO e-ctd Clinitrial Oracle Clinical 3.1.4 EDC EDC(Electronic Data Capture)EDC CDMS EDC 3.l.5 CDISC FDA CRO CDISC CDISC CDISC CDISC SDTMSENDLAB SDTMLABODMdefine.xml 48
IT 2006 CDISC EDC HL7 3.x CDISC PR CDISC SDTMLABODMdefine.xml 2006 CDISC CDISC 3.2 3.2.1 HERHIS HL7 HL HL HL7 3.x CDISC CDISC CDISC CDISC CDISC CDISC 49
IT HL7 CDISC LAB HL7 3.x CDISC ODM 3.2.2 EDC EDC EDC CDISC ODMCDISC ODM EDC EDC CDISC CDISC ODM EDC CDISC ODM EDC EDC Web EDC CDISC EDC EDC EDC CDISC CDISC CDISC 50
IT EDC CDISC EDC CDISC CDISC ( CDISC ) EDC EDC 3.3 CRO CDMS CRO CDMS CDISC CDMS CDMS CDMS CDMS DCRIQuintiles CDMS CDMS CDISC CDMS SDTM CDMS SDTM SDTM DCRI CDMS SDTM 60-70% SDTM CDMS CDMS CDMS CDISC 51
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IT CDISC HL7 HL HL7 version 3.x HL7 version 3.x CDISC CDISC / Clinitrial Oracle Clinical CDISC CDISC 53
IT 2005 2005-2006 2006 2007-2010 CDISC EDC CDISC EDC CDISC SDTMSEND LAB ODM define.xml ADaM PR Terminology 2005 2005-2006 2006 2007-2010 SDTMSEND LAB SDTMSEND LAB ODM define.xml SDTMSEND LAB ODM define.xml ADaM SDTMSEND LAB ODM define.xml ADaM PR HL7 HL7 2.x HL7 3.x CDISC HL7 HIS/ HL7 HL7 HIS/ HL7 CDISC ODM HIS/ HL7 HIS/ 54
IT HL7 CDISC HL CDISC / / HL7 2.x / HL7 2.x CDISC LAB / CDISC LAB CDISC ODM HL7 3.x 55
IT HIS/ HIS/ CDISC ODM CDISC ODM HIS/ CDISC ODM CDISC ODM HIS/ CDISC ODM CDISC ODM HIS/ CDISC ODM HIS/ 5 EDC 56
IT CDMS CDMS SDTM SDTM ODM CDMS CDMS SDTM SDTM ODM CDMS SDTM SDTM SDTM SDTM ODM CDISC 57