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Xxxxxxx - CDISC

CDISC standards CDASH 10-MAR-2012 CDISC Japan User Group (CJUG) 2 Sponsor A Regulatory Sponsor AB

Site Sponsor B 3 Contents 1. 2. 3. 4. CDISC overview CDISC standards CDASH CDISC membership / CJUG

4 Clinical Data Interchange Standards Consortium 1997 : FDAFDA Rebecca FDAKush 2000 : FDA CDISC 2004 : FDAFDA FDANews 5

2004 7 FDA News 6 2004 10 Mission Statement The FDACDISC FDAmission FDAis FDAto FDAdevelop FDAand FDAsupport FDA global, FDAplatform-independent FDAdata FDAstandards FDAthat FDA enable FDAinformation FDAsystem FDAinteroperability FDAto FDA improve FDAmedical FDAresearch FDAand FDArelated FDAareas FDAof FDA healthcare. FDA 7 CDISC

CCC CDISC FDACoordinating FDACommittee x3C x CDISC FDACoordinating FDA Committee 2000 2001 2008 2002 8 CDISC in Japan 2002 : FDACDISC FDA 2002 : FDAJapan FDACDISC FDACoordinating FDACommittee FDA FDA FDA

(J3C) FDA 2003 : FDAJapan FDACDISC FDAGroup FDA(JCG) 2003 : FDA1st FDAWorkshop FDA(JCG FDAMeeting) 2005 : FDA1st FDAJapan FDACDISC FDAInterchange 2010 : FDACDISC FDAJapan FDAUsers FDAGroup 2012 : FDA9th FDAWorkshop FDA/ FDA7th FDAJapan FDAInterchange 9 10 2007 3 30 11

2012 (2012 3 30 ) 12 Contents 1. 2. 3. 4. CDISC overview CDISC standards CDASH CDISC membership / CJUG 13

CDISC Protocol Representation (PR) Clinical Data Acquisition Standards Harmonization (CDASH) Study Data Tabulation Model (SDTM) Standard for Exchange of Nonclinical Data (SEND) Analysis Data Model (ADaM) Laboratory Data Model (LAB) Operational Data Model (ODM) Case Report Tabulation Data Definition Specification (define.xml) Biomedical Research Integrated Domain Group(BRIDG) Healthcare Link(HL) etc. 14 CDISC

CDISC FDABrochure FDA( FDA 15 PR Protocol Representation Model Protocol FDARepresentation FDAGroup(*) FDA(*)2002 HL7 CDISC HL7 FDA RCRIM CDISC NCI caBIG WHO CRO FDA EMEA UML Unified FDAModeling FDALanguage Domain FDAAnalysis FDAModels

IRBs CRF 16 Critical Path Opportunities #45 Consensus on Standards for Case Report Forms Clinical trial data collection, analysis, and submission can be inefficient and unnecessarily expensive. Standardization of the look and feel of case report forms could reduce these inefficiencies and also help accelerate progress toward electronic data capture and submission.

17 CDASH Clinical Data Acquisition Standard Harmonization FDAHighly FDARecommended FDARecommended FDA/ FDAConditional FDAOptional 18 [ ] CDASH

CDASH 3 DM CRO DM Japan FDACDISC FDACoordinating FDACommittee(J3C) FDA/ FDACDISC FDA Japan FDAUser FDAGroup(CJUG) 2011 12 CDISC FDAPortal FDASite FDAJapan Approved FDADocument web %20Networks/Asia/Japan/default.aspx 19 SDTM Study Data Tabulation

Model FDA SDTM (2006.4) eCTD SDTM (CDASH) SDTM( ) SEND( )

SDTM SEND 20 SEND Standard for Exchange of Nonclinical Data in FDAvitro FDA SDTM 21


FDA SDTM Safety FDAReview 22 CDASH 01/02/03 2001 2 3 2003 1 2 2003 2 1 SDTM ISO8601 2001-02-03

CDASH 03-Feb-2001 03-Fv-2001 SDTM CDASH 23 ADaM Analysis Data Model SDTM FDA ADaM

SDTM Other ADaM Analysis Dataset Creation Process Analysis Dataset Analysis Dataset Metadata Data Flow

Description Analysis Results Generation Process Analysis Results Analysis Results Metadata , SAP 24

CDISC PR Protocol CDASH CRF ADaM FDA SDTM +define.xml SEND ( ) CRF Site

LAB Regulatory Sponsor Laboratory ODM FDA / 25 LAB Clinical Laboratory Data Model

Content FDALayer FDA Standard FDALaboratory FDAData Microbiology FDAExtension Pharmacogenomic FDAExtension Implementation FDALayer FDA ASCII, FDASAS FDATransport, FDAXML, FDAHL7 FDAVersion3 FDAmessage, FDAetc 26 ODM Operational Data Model

21 FDACFR FDApart FDA11 FDA XML RFD(Retrieve FDAForm FDAfor FDAData FDACapture) Site ODM Sponsor CDASH SDTM ODM

Regulatory ODM 27 Define.xml Case Report Tabulation Data Definition Specification XML machine FDAreadable

FDA SDTM, FDAADaM xpt SAS define.xml 28 BRIDG Biomedical Research Integrated Domain Group Model CDISC


BRIDG CDISC: FDAIn FDAearly FDA2004, FDACDISC FDAstarted FDAconstructing FDAa FDADomain FDAAnalysis FDAModel FDAto FDA support FDAharmonization FDAof FDAtheir FDAstandards FDAfor FDAclinical FDAresearch FDAas FDAwell FDAas FDAwith FDAthe FDA Health FDALevel FDASeven FDA(HL7) FDAhealthcare FDAstandard. NCI: FDAIn FDAlate FDA2004, FDANCI's FDACancer FDABiomedical FDAInformatics FDAGrid FDA(caBIG) FDAinitiative FDA joined FDAthe FDACDISC FDABRIDG FDAefforts FDAto FDAconstruct FDAa FDAstructured FDAprotocol FDA representation FDAfor FDAits FDAClinical FDATrials FDAManagement FDASystems FDA(CTMS) FDAWorkspace, FDA in FDAorder FDAto FDAfurther FDAinteroperability FDAamong FDAclinical FDAtrials FDAresearch FDAin FDAcancer. HL7: FDA FDAIn FDA2005, FDAthe FDABRIDG FDAmodel FDAwas FDAadopted FDAby FDAthe FDAHL7 FDARegulated FDAClinical FDA Research FDAInformation FDAManagement FDA(RCRIM) FDATechnical FDACommittee FDAas FDAthe FDA RCRIM FDADomain FDAAnalysis FDAModel. FDA 2004 CDISC, FDAHL7 FDARCRIM, FDANCI, FDAFDA

FDA: FDAIn FDA2007, FDAthe FDAUS FDAFood FDAand FDADrug FDAAdministration FDAincluded FDABRIDG FDAin FDAtheir FDA5 FDA year FDAIT FDAPlan FDAas FDAa FDAfoundation FDAfor FDAseveral FDAprojects. BBoD SCC FDA HL7 CDISC NCI caBIG HL7

FDA Academia Pharma Industry CDISC BBoD [BRIDG Board of Directors] BRIDG SCC [Semantic Coordination Committee] 30 BRIDG Model Semantics -

1 2 orz UML Unified FDAModeling FDALanguage 31 HL Healthcare Link CDISC IHE FDA RFD Retrieve FDAForm FDAfor FDAData FDA Capture

Clinical Research Safety AE FDAReport Public Health Outbreak FDAReport CRF EHR Quality FDAMeasure Quality

Contents 1. 2. 3. 4. CDISC overview CDISC standards CDASH CDISC membership / CJUG 33 CDASH CDASH Standard CDASH


35 1. 2. CRF / / 3. 4. 5. 6. 7. 8. CRF 9. 10. 36 CRF

37 CRF FAQ Question, FDACRF FDAType, FDABest FDAPractice FDA Recommendation, FDARationale FDA 4 FAQ CDASH FDAVer.1.1 [Question] CRF [Best Practice Recommendation] CDASH DD-MMM-YYYY CRF 2008 2 2 02-FEB-2008 CRF 02-FEV-2008 38

CDASH User Guide The CDASH User Guide (CDASH UG) is now available to CDISC members. The CDISC UG provides CDASH implementation examples, including CDASH to SDTM mappings, CDASH ODM files and a library of example CRFs that have been created in several different data collection systems, including paper examples. The CDASH team plans to update the CDASH UG with additional examples as they become available. CDISC Members can download the CDASH User Guide CDISC web CDASH 39

Contents 1. 2. 3. 4. CDISC overview CDISC standards CDASH CDISC membership / CJUG 40 CDISC members enjoy these benefits and more Stay informed and make a difference: provide your input and directly impact the standards development process,

while connecting with peers and keeping abreast of industry trends and best practices Access to CDISC Members Only Area on for information about recent FDA/CDISC activities, implementation best practices, tips and tools Receive significant discounts on CDISC events and education Can be recognized as Registered Solutions Providers to other organizations Leadership and networking through participation on the CDISC Advisory Board CDISC web Membership 41 CJUG CDISC Japan User Group

5 PR CDASH SDTM SEND ADaM CJUG CJUG [email protected]



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