CDISC標準の概要 - umin.ac.jp

1 CDISC UMIN CDISC SAS CDISC CDISC CDISC EDC CDISC SAS CDISC CDISC CDISC EDC CDISC CDISC Clinical Data Interchange Standards Consortium CRO ARO IT CDISC CDISC (CDISC Standards) CDISC SDTMS tudy Data Tabulation Model SENDS tandard Exchange for Non-clinical Data ADaMAnalysis Dataset Model CRT-DDS Case Report Tabulation and Data Definition Specification PDF XML ODMO perational Data Model XML LAB Clinical Laboratory Model XML PRProtocol Representation CDASH Clinical Data Acquisition Standards Harmonization ( CDISC LabLab)

2 XML ODM XML sdtm ( SEND ADaM SAS xpt CRT-DDS PDF XML sdtm ( SEND ADaM ) sdtm ( SEND ADaM )CDASH PR XML CDISC ICH EU ICH (International Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use) EU CDISC CDISC ICH (EMEA) (PMDA) (FDA)ICH CDISC A B C CDISC CDISC EHR Communication HL CDISC EHR Communication HL (ISO13606) EDC CDISC CDISC EHR Communication HL HL7 ver.)

3 RIMHL7 ver. BRIDG Model CDISC sdtm CDISC CDISC BRIDG EHR EHRC ommunication CDISC CDISC EHR Communication HL HL7 ver. BRIDG Model CDISC sdtm CDISC CDISC EHR EHR EHRC ommunication ANSI CDISC CDISC EHR Communication, HL EHR Communication HL7 CDISC HL7 EHR CommunicationCDISC CDISC CDISC HL HL7 CDISC ISO CDISC HL7 CDISC ISO Liaison A status ISO CDISC CDISC ANSI ISO International Organization for Standardization) [ ]JIS[C](Japan Industrial Standards [Committee])

4 ANSI (American National Standards Institute) CEN (Comite Europeen de Norm) CDISC ID Visit ID CDISC CDISC IT CDICS

5 IT CDISC CDISC SAS CDISC CDISC CDISC EDC SAS sdtm XML DTD Schema SAS SASFDA -1997 FDA 1997 FDA: 1997 DIA Special Interest Group CDISC (FDA ) 1999 FDA: SAS xpt, PDF 2004 FDA: e-CTD Study Data Specification ver.

6 CDISC sdtm 2005 FDA: e-CTD Study Data Specification ver. CDISC sdtm SASFDA SAS version 5 xpt PDF SAS version 5 xpt PDF (CDISC sdtm ) SASFDA CDISC sdtm FDA (Reference) FDA (Recommendation) FDA Obligatory) SASFDA CDISC EDCCDISC FDA CDISC CDISC-friendly) CDISC CDISC EDC Electronic Data Capture CDISC SASFDA CDISC EDCCDISC FDA CDISC CDISC CDISC CDISC CDISC EDC CDISC sdtm CDISC SDTMCDISC SDTMCDISC ODM SASSAS version 5 Version 8 32 Version 8 32 1

7 200 Version 8 32,767 SASSAS version 5 SAS version 5 CDISC CDISC CDISC CDISC SAS CDISC CDISC CDISC EDC CDISC CDISC (CDISC Standards)CDISC SDTMS tudy Data Tabulation Model SENDS tandard Exchange for Non-clinical Data ADaMAnalysis Dataset Model CRT-DDS Case Report Tabulation and Data Definition Specification PDF XML ODMO perational Data Model XML LAB Clinical Laboratory Model XML PRProtocol Representation CDASH Clinical Data Acquisition Standards Harmonization XML ( CDISC LabLab XML)

8 ODM XML sdtm ( SEND ADaM SAS xpt XML CRT-DDS PDF XML sdtm ( SEND ADaM ) sdtm ( SEND ADaM )CDASH PR XML CDISC (Concomitant Medications) (Exposure) (Adverse events) (Medical history) (Disposition) (Protocol deviation) (Substance use) (Questionnaires) (Physical Examinations) (Laboratory Tests) (ECG Tests) / (Inclusion/ExclusionExceptions) (Drug Accountability) (MicrobiologySpecimens) (MicrobiologySusceptibility) PC (Pharmacokinetics Concentration)PP (Pharmacokinetics Parameters) (Demographics) (Comments) (SupplementalQualifiers) (Comments) SVTATITESE (Subject visits) (Trial elements) (Trial Arms) (Subject elements) (Trial Inclusion/Exclusion Criteria) TV (Trial visits) (Trial Summary)TSEXSUCMAEMHDSDVDMCO suppqual CDISC.)

9 --TRT Char --MODIFY DECOD --MODIFY Char --DECOD Char* --CAT Char* --SCAT Char* --OCCUR Char* Y N)--STAT Char* null NOT DONE --REASND Char--STAT NOT DONE --INDC Char --CLAS Char* --CLASCD Char* --DOSE Num --DOSTXT Char --DOSU Char* --DOSFRM Char* --DOSFRQ Char* BID,TID,QID--DOSTOT 1 Num DOSU 1 --DOSRGM Char --ROUTE Char* ORAL, INTRAVENOUS --LOT Char --LOC Char* --TRTV Char* SALINE--ADJ Char* CDISC.

10 EXTRT Char EXMODIFY EXDECOD EXMODIFY Char EXDECOD Char* EXCAT Char* EXSCAT Char* EXOCCUR Char* Y N)EXSTAT Char* null NOT DONE EXREASND CharEXSTAT NOT DONE EXINDC Char EXCLAS Char* EXCLASCD Char* EXDOSE Num EXDOSTXT Char EXDOSU Char* EXDOSFRM Char* EXDOSFRQ Char* BID,TID,QIDEXDOSTOT 1 Num DOSU 1 EXDOSRGM Char EXROUTE Char* ORAL.