CDISC標準入門セミナー（3） 目次 - umin.ac.jp

1 1 cdisc SEND Standard for Exchange of Nonclinical Data Implementation Guide umin SAS SDTM SEND SEND SEND SEND / SEND SEND SAS SEND SAS SAS cdisc SAS SAS FDA XML cdisc LabLab XML ODM XML SDTM( SEND ADaM SAS xpt XML CRT-DDS PDF XML SDTM( SEND ADaM )SDTM( SEND ADaM ) XML CDASH XML PR XML cdisc LabLab XML ODM XML SDTM( XML SEND XML ADaM ) XML SDTM( XML SEND XML ADaM ) XML CDASH XML PR (XML XML ODM XML 2 SAS xpt SAS 2007 09 19 07 14 44 23 OBS seimeibh bwbmi1 kiuchitakahiro172 75 suzukiichiro185 75 matsuihideki177 77 jojimakenji181 78 SAS version 5 Version 8 32 Version 8 32 1 200 Version 8 32,767 SEND SDTM SDTM SEND SDS (2000/10) SDS (2001/12) SDS (2003/06)SDTM (2004/06) SDTM Implementation Guide (2004/06 )SDTM (2005/04) SDTM Implementation Guide (2005/08 ) SEND (2005/11 )))

2 Implementation Guide SDS Submission Data Standards Submission Data Domain Models SDTM Submission Data Tabulation Model SDTM Implementation Guide = SDS SEND Standard for Exchange of Nonclinical DataSDTM SDTM Implementation Guide SDS SEND Implementation Guide SEND SEND SEND (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) (RelatedRecords) SVTATITESE (Subject visits) (Trial elements) (Trial Arms) (Subject elements) (Trial Inclusion/Exclusion Criteria) TV (Trial visits) (Trial Summary) EXSUCMAEMHDSDVDMCO suppqual (Subject Characteristics) (Vital Sign)SEND (Exposure) / CPEGFWBWDLGCMI (Clinical Pathology) (Body Weights) (Drug/Metabolites Level) (ECG Tests) Clinical Signs, Physical And Opthalmoscopic Examination) (Microscopic Findings) (Food and Water Consumption) (Group Characteristics) DS (Disposition)MA (Macroscopic Findings) (Comments) (RelatedRecords) (Organ Weight) (Subject Characteristics) (Vital Signs)SS (Study DesignSummary)

3 (Concomitant Medications) / / QSMBPELBMSIE (Substance use) (Questionnaires) (Physical Examinations) (Laboratory Tests) / (Inclusion/ExclusionExceptions) (MicrobiologySpecimens) (MicrobiologySusceptibility) PC (Pharmacokinetics Concentration) (Demographics) SVTATITESE (Subject visits) (Trial elements) (Trial Arms) (Subject elements) (Trial Inclusion/Exclusion Criteria) TV (Trial visits) (Trial Summary) (Drug Accountability)PP (Pharmacokinetics Parameters) (SupplementalQualifiers) (Adverse events) (Medical history) (Disposition) (Protocol deviation) SEND (Exposure) / EG (ECG Tests) DS (Disposition) (Comments) (Related Records) (Subject Characteristics) (Vital Signs) / CPFWBWDLGCMI (Clinical Pathology) (Body Weights) (Drug/Metabolites Level) Clinical Signs, Physical And Opthalmoscopic Examination) (Microscopic Findings) (Food and Water Consumption) (Group Characteristics) PP (Macroscopic Findings) ow (Organ Weight) (Study DesignSummary) SEND / QSEGMBPELBMSDA (Questionnaires) (Physical Examinations) (Laboratory Tests) (ECG Tests) (Drug Accountability) (MicrobiologySpecimens) (MicrobiologySusceptibility) PC (Pharmacokinetics Concentration)PP (Pharmacokinetics Parameters)

4 (Subject Characteristics) (Vital Signs)SCVSCPEGFWBWDLMI (Clinical Pathology) (Body Weights) (Drug/Metabolites Level) (ECG Tests) Clinical Signs, PhysicalAnd OpthalmoscopicExamination) (Microscopic Findings) (Food and Water Consumption) MA (Macroscopic Findings) (Organ Weight) (SubjectCharacteristics) (Vital Signs) SDTM SEND SEND -> -> SEND 4 SEND (Exposure) / CPEGFWBWDLGCMI (Clinical Pathology) (Body Weights) (Drug/Metabolites Level) (ECG Tests) Clinical Signs, Physical And Opthalmoscopic Examination) (Microscopic Findings) (Food and Water Consumption) (Group Characteristics) DS (Disposition)MA (Macroscopic Findings) (Comments) (RelatedRecords) (Organ Weight) (Subject Characteristics) (Vital Signs)SS (Study DesignSummary) (Intervention class (1) (2) Event class) / Finding class) SEND - Role)1) Identifier variables )

5 Timing variables / / --TRT - -- --TRT EX EXTRT STUDYID Char DOMAIN Char* 2 USUBJID ID Char ID--SEQ Num --GRPID ID Char --REFID ID Char ID ECG UUID--SPID ID Char STUDYID: DOMAIN: USUBJID --SEQ --REFID --GRP --SPID SDTM SEND STUDYID DOMAIN USUBJID LBSEQ LBTESTCD LBTEST LBCAT LBSCAT LBORRES LBORRESU LBORNRLO LBORNRHI 1 ABC LB ABC-001-001 1 ALB Albumin Chemistry 34 g/L 35 50 2 ABC LB ABC-001-001 2 ALKP Alkaline Phosphatase Chemistry 398 IU/L 40 160 3 ABC LB ABC-001-001 3 ALKP Alkaline Phosphatase Chemistry 350 IU/L 40 160 LBSTRESC LBSTRESN LBSTRESU LBSTNRLO LBSTNRHI LBSTAT LBREASND LBBLFL LBFAST LBDRVFL VISIT VISITNUM LBDTC 1 (cont) g/dL 5 Y Y BASELINE 1 1999-06-192 (cont)

6 398 398 units/L 40 160 Y BASELINE 1 1999-06-193 (cont) 350 350 units/L 40 160 Y BASELINE 1 1999-06-20 5 SEND cdisc SEND / cdisc SEND (Exposure) / CPEGFWBWDLGCMI (Clinical Pathology) (Body Weights) (Drug/Metabolites Level) (ECG Tests) Clinical Signs, Physical And Opthalmoscopic Examination) (Microscopic Findings) (Food and Water Consumption) (Group Characteristics) DS (Disposition)MA (Macroscopic Findings) (Comments) (RelatedRecords) (Organ Weight) (Subject Characteristics) (Vital Signs)SS (Study DesignSummary) SEND EX EX (Exposure) --TRT Char --MODIFY DECOD --MODIFY Char --DECOD Char* --CAT Char* --SCAT Char* --OCCUR Char* Y N)

7 --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,QD--DOSTOT 1 Num DOSU 1 --DOSRGM Char --ROUTE Char* ORAL, INTRAVENOUS --LOT Char --LOC Char* --TRTV Char* --ADJ Char* SEND EX EX (Exposure) SUBDYID Char USUBJID Char ARMCD Num DOMAIN Char* EXGRPID ID Char IDEXSEQ Num EXTRT Char EXTRTV Char* EXDOSE Num EXDOSU Char* EXDOSFRM Char* EXDOSFRQ Char* BID,TID,QIDEXDOSTOT 1 Num DOSU 1 EXROUTE Char* ORAL.

8 INTRAVENOUS EXLOT Char EXSTDTC Char EXENDTC Char EXDUR Char EXELTM Char EXTPTREF Char EXRFTDTC Char EX UM1490 STUDYID ARMCD USUBJID EXTRT EXDOSE EXDOSU EXDOSFRM EXDOSFRM EXDOSTOTEXROUTE EXSTDTC EXENDTC ( ) 58902 1 201 UM1490 500 mg capsule once a day 500 oral 2008-07-11 2008-07-1158902 1 202 UM1490 500 mg capsule once a day 500 oral 2008-07-11 2008-07-1158902 1 203 UM1490 500 mg capsule once a day 500 oral 2008-07-11 2008-07-1158902 1 204 UM1490 500 mg capsule once a day 500 oral 2008-07-11 2008-07-1158902 2 205 UM1490 1000 mg capsule once a day 1000 oral 2008-07-11 2008-07-1158902 2 206 UM1490 1000 mg capsule once a day 1000 oral 2008-07-11 2008-07-1158902 2 207 UM1490 1000 mg capsule once a day 1000 oral 2008-07-11 2008-07-1158902 2 208 UM1490 1000 mg capsule once a day 1000

9 Oral 2008-07-11 2008-07-1158902 3 209 UM1490 1500 mg capsule once a day 1500 oral 2008-07-11 2008-07-1158902 3 210 UM1490 1500 mg capsule once a day 1500 oral 2008-07-11 2008-07-1158902 3 211 UM1490 1500 mg capsule once a day 1500 oral 2008-07-11 2008-07-1158902 3 212 UM1490 1500 mg capsule once a day 1500 oral 2008-07-11 2008-07-1158902 4 213 UM1490 2000 mg capsule once a day 2000 oral 2008-07-11 2008-07-1158902 4 214 UM1490 2000 mg capsule once a day 2000 oral 2008-07-11 2008-07-1158902 4 215 UM1490 2000 mg capsule once a day 2000 oral