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1 CDISC CDISC standard CDISC Clinical Data Interchange Standards Consortium 1990 standard CDISC standards FDA specification FDA FDA CDISC FDA (the operational use of data) CDISC CDISC CDISC CDISC standard CDISC Clinical Data Interchange Standards Consortium CDISC SDTM Study Data Tabulation Model FDA CRO Clinical Research Organization CDISC CDISC

2 CDISC CDISC CDISC CDISC FDA FDA CDISC FDA CDISC CDISC CDISC FDA FDA 1990 FDA NDA New Drug Application FDA FDA 2 NDA 2 FDA

3 1997 FDA Electronic Records; Electronic Signatures (1) FDA 1 FDA CDER Center for Drug Evaluation and Research CBER Center for Biologics Evaluation and Review FDA NDA BLA Biologics Licensing Application Adobe PDF SAS XPT FDA 1999 FDA 2 Providing Regulatory Submissions in Electronic Format General Considerations (2) PDF XPT CDER NDA Providing Regulatory Submissions in Electronic Format NDAs (3) 1999 CRT Case Report Tabulation CRT 3 1 BLANKCRF.PDF CRF Case Report Form 2 DEFINE.PDF PDF CDER

4 CDER 12 domain CBER 1999 BLA Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format Biologics Marketing Applications (4) CDER FDA NDA BLA FDA PDF XPT FDA 1997 OMG Operational Management Group Industry-standards Glossaries 1998 DIA Drug Information Association SIAC Special Interest Area Committees CDISC SIAC Nomenclature 2 DIA 2 5 Glossary Terminology SDS Submission Data Standards ADaM Analysis Data Model ODM Operational Data Management LAB Laboratory Data 4

5 CDISC CDISC Submission Metadata Model (5) DIA 1999 FDA 1999 SAS V5 PDF DEFINE.PDF 2000 4 David Christiansen Wayne Kubick CDISC Submission Metadata Model 1.1 2 FDA XPT FDA CDISC SDS Submission Data Standards CRT PDF PDF CDISC Core Variable

6 NDA CDISC CDISC ODM ADaM LABS SDS ODM Operational Data Modeling ODM 1999 CDISC CDM Clinical Data Management 2 CDM CDISC CDISC 2 Phase Forward PHT CDISC XML Extensible Markup Language XML CDISC CDISC CRO 2 CDM Clintrial Oracle Clinical 2 2 CDISC 3 Data Sources Operational Data Submission Data Operational Data

7 FDA CDISC 2 FDA CDISC 2000 2 LAB ADaM Analysis Data Modeling FDA Patient Profile Viewer CRADA 2001 FDA FDA CTOC Cumulative Table of Contents IND Investigational New Drug FDA FDA CRADA Cooperative Research and Development Agreement CRADA FDA

8 CRADA PPV Patient Profile Viewer 2001 12 FDA PPV CRADA CRT FDA PPD Informatics CrossGraphs FDA EXPOSURE AE FDA PDF PDF PPV CDISC SDTM 2.0 CDISC SDS FDA SDS FDA Patient Profile Viewer CRADA PPV 2001 11 Submission Metadata Model 2.0 2001 12 CDISC Submission Data Domain Model v2.0 SDDM (6) 1 PDF

9 2.0 ECG Vital Signs vertical more-normalized FDA ECG Vital Signs 2.0 ECG LOINC Logical Observations, Identifiers, Names and Codes 1990 2000 CDISC SDDM 2.0 SDDM CDISC Global Data Integration Database SAS SDDM Submission DB Analysis DB Integration DB Global Integration and Analysis Databases GIADB 2002 Patient Profile Viewer CRADA FDA PPV CRADA PPP Patient Profile Pilot FDA Patient Profile Viewer CDISC SDS PPP SDDM 2.0 PPP 2002 CDISC SDS SDDM 2.1 2.0 SDS ODM PPP SDDM

10 CDISC SDDM Patient Profile Pilot SDS CDISC ANSI American National Standards Institute HL7 Health-Level 7 CDISC HL7 8 SDS FDA FDA Patient Profile Viewer FDA ANSI American National Standards Institute HL7 Health-Level 7 HL7 FDA SDS FDA FDA FDA 2.0 8 2.1 FDA HL7 CRT FDA PPV CDISC SDS 2.1 3.0 FDA HL7 2.0 2.1

11 LAB LAB 1.0.0 LAB XML FDA CRADA 2003 3 SDS Version 3.0 Submission Data Standards - Review Version 1.0 (7) General Study Data Information Model CDISC Submission Domain Model 3 2 SDDM 2.0 HL7 HL7 SDS HL7 CDISC Submission Data Domain Models Version 3.0 - Final Version 1.2 (8) SDDM 2 3.0 FDA CRT 3 1 2 3 findings interventions special purpose 3 3

12 2003 4 DEFINE.XML ODM ADaM SDS ODM XML DEFINE.PDF FDA FDA CRT-DDS Case Report Tabulation Data Description Specification (12) HL7 HL7 HL7 CRT-DDA 1.0.0 2005 2 3.0 2 2003 2003 10 FDA 8 2 1 3.0 3.0 3.0 3.0 3.0 2.0 2.1 2.1 FDA CDISC SDS 2004 6 2 CDISC Submission Data Tabulation Model version 1.0 (SDTM) (9) SDTM Implementation Guide V3.1 (I.G.) (10) SDTM IG 3.1

13 define.xml SDTM IG 3.1 Trial Design 2004 8 12 ADaM Statistical Analysis Dataset Model: General Considerations Version 1.0 (11) 5 CDISC Submission Metadata Model Define.XML CRT-DDA 1.0 SDTM 3.1 nomenclature ectd SDTM 3.1 FDA ectd 2003 11 5 FDA 2004 3 14 ectd FDA 2004 7 FDA ectd ectd Study Data Specifications v1.0 (13) Study Data Specifications FDA ectd Data Tabulation CDISC SDTM 3.1 SDTM 3.1 CDISC SDTM FDA SDTM 3.1 ectd FDA CDISC SDTM 3.1

14 ectd FDA CDISC SDTM 3.1 2004 ectd FDA 2004 CDER CBER ectd NDA BLA 12 IND2 100 2004 137 original 81 1999 ectd FDA ectd 1999 ectd 2 FDA FDA 2003 9 FDA NPRM Notice of Proposed Rulemaking NPRM 2005 6 2004 12 2005 5 FDA 2005 10 NPRM 2005 10 HHS FDA HHS 2006 7 NPRM 2 NPRM FDA FDA 2005 5 ectd Study Data Specifications 1.1 (14) CDISC SDTM 3.1 CDISC ectd Clinical SDTM 3.1 CDISC SEND Standard for Exchange of Nonclinical Data 2002 SDTM CDISC SEND SEND 2004 12 1.7.5 (14) 2005 3

15 ectd CDISC CRT-DDS define.xml ectd ectd CDISC 1999 ectd 2005 CDISC SDTM ectds 2005 9 2003 2005 NDA 46 588 BLA 11 233 IND 43 234 2005 2006 6 ectd CDISC 2003 2005 CDISC SDTM CDISC CDISC CRF DMS Data Management Systems CDISC CDISC-like CDISC CDISC-friendly CDISC SDTM 3.1 DMS SDTM 3.1 CDISC SDTM SDMT 3.1

16 SDTM 3.1 SDTM AGE Case Report Form date of birth randomization date SDTM 3.1 Susan J. Kenny Jack Shostak PharmaSUG Pharmaceutical SAS User Group (15),(16) Shostak (15) SDTM 3 1) SDTM DMS 2) SDTM SAS 3) 2 SDTM + SDTM DMS SDTM 2 SDTM DMS SDTM 2 3.1 3.1 1 DMS DMS 3 DMS

17 DMS CDISC SAS CDISC SDTM CDISC USUBJID Unique Subject Identifier SDTM 1 USUBJID DMS USUBJID DMS SUBJID CDISC SAS SUBJID USUBJID USBUJID SDTM DMS SAS CDISC DMS SDTM 3.1 2005 4 ADaM Change from Baseline Analyses Categorical Data Analyses Subject-Level Analyses 3 Susan Kenny 4 (16) 1) Parallel Method 2) Retrospective Method 3) Linear Method 4) Hybrid Method

18 DMS SDTM 1 SDTM DMS DMS SDTM 2 2 SDTM 2 SDTM SDTM FDA 2 2 FDA 2 DMS SDTM

19 DMS SDTM SDTM FDA DMS CDISC SDTM SDTM SDTM 3 DMS SDTM SDTM DMS SDTM DMS CDISC DMS SDTM SDTM SDTM FDA SDTM 4

20 DMS SDTM SDTM DMS SDTM SDTM DMS CDISC DMS SDTM SDTM SDTM 4 SDTM SDTM SDTM CDISC HL7 FDA FDA CDISC CDISC HL7 CDISC PR Protocol Representation SDTM PR WHO NCI National Cancer Institute

21 PR CDISC FDA FDA SDTM 3.1 ADaM CRF DEFINE.PDF DEFINE.XML CDISC BRIDG HL7 CDISC UML Unified Modeling Language BRIDG CDISC LAB ODM LAB ODM ODM XML CRT-DDS DEFINE.XML FDA ODM SAS Phase Forward ClinTrial Oracle Clinical ODM

22 CDISC CDISC FDA CDISC CDISC FDA CDISC (1) FDA - Electronic Records; Electronic Signatures (ERES rule) (2) FDA - CDER/CBER - Providing Regulatory Submissions in Electronic Format General Considerations (3) FDA - CDER - Providing Regulatory Submissions in Electronic Format NDAs (4) FDA - CBER - Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format Biologics Marketing Applications (BLAs) (5) CDISC Submission Metadata Model (6) CDISC Submission Data Domain Model v2.0 (SDDM) (7) CDISC Version 3.0 Submission Data Standards - Review Version 1.0 (8) CDISC Submission Data Domain Models Version 3.0 - Final Version 1.2 (9) CDISC Submission Data Tabulation Model version 1.0 (SDTM) (10) CDISC SDTM Implementation Guide V3.1 (I.G.) (11) CDISC Statistical Analysis Dataset Model: General Considerations Version 1.0 (12) CDISC Case Report Tabulation Data Description Specification (CRT-DDS) v1.0.0 (13) FDA - ectd - Study Data Specifications v1.0 (14) FDA - ectd Study Data Specifications v1.1 (15) CDISC Standard for Exchange of Nonclinical Data (SEND) v1.7.5 (16) PharmSUG 2005 Paper FC01 - Implementation of the CDISC SDTM at the Duke Clinical Research Institute, Jack Shostak, Duke Clinical Research Institute (DCRI), Durham, NC

23 (17) PharmaSUG 2005 Paper FC03 - Strategies for Implementing SDTM and ADaM Standards, Susan J. Kenny, Maximum Likelihood Solutions, Inc and Octagon Research Solutions, Inc., Chapel Hill, NC (18) Michael A. Litzsinger, SCHWARZ BIOSCIENCES, Inc., Research Triangle Park, NC FDA http://www.fda.gov/ CDSIC http://www.cdisc.org//index.html PharmaSUG 2005 http://www.pharmasug.org/ URL CDISC CDISC Wayne Kubick - Lincoln Technologies Gary Walker Quintiles Quintiles Kansas RTP (North Carolina) CDISC Task Force Gary Walker ( (Quintiles Transnational Japan K.K.))