1. 1 SDS&ADaM sub-team 28 January 2004 Mineko FUJIMOTO Rieko ICHIHARA Kazue TOMITA Hiroaki MATSUDA

2. 2 SDS central team mission Provide regulatory submission reviewers with clear descriptions of the usage, structure, contents & attributes of all submitted datasets and variables Define standard data formats to allow reviewers to use standard tools:

3. 3 ADaM central team mission Provide metadata models and examples of analysis datasets that are used to generate the statistical results for a regulatory submission.

4. 4 SDS&ADaM team task step and member Understand the CDISC data models Identify Japanese requirements Provide Japanese inputs to central modeling team 20 members, 12 from SDS and 8 from ADaM

5. 5 SDS&ADaM teams SDS translation ADaM translation SDS manual Identify Japanese Requirements 1st step INPUT to Central 2nd step ADaM manual

6. 6 History of SDS&ADaM team Apr 8, 20031 st meeting; Kick off Apr 9Opened Mailing list Apr 10Started translation ; text parts Jun 10,2003 Released SDS ver.3.0 final version Jul 22, 20032 nd meeting; follow-up Sep 16, 20043 rd meeting Sep 26Started reviewing Oct 7 Started translation ADaM standard Dec 19Started translation; domain models Jan. 15, 20044 th meeting

7. 7 To Understand SDS model Translate the model and a related guidance Related guidance: To understand “Case Report Tabulation”, “Guidance for Industry, Providing Regulatory Submissions in Electronic Format — NDAs” Model : SDS version 3.0 final version

8. 8 Progress of translation SDS model Table of Contents 1 INTRODUCTION...................................................................................................................4 2 GENERAL STUDY DATA INFORMATION MODEL.............................................................6 3 CDISC SUBMISSION DATA DOMAIN MODELS...............................................................26 3.1 Standard Dataset Content/Attributes of Domains.......................................................26 3.2 Using the CDISC Domain Models in Regulatory Submissions..................................26 3.3 Conformance..................................................................................................................27 3.4 Commenting on the V3 CDISC Submission Data Domain Models............................27 3.5 Domain Metadata Models..............................................................................................28 3.5.1 General Assumptions for All Domains.................................................................28 3.5.2 CDISC Submission Dataset Definition Metadata.................................................35 3.5.3 Domain Models and Domain-Specific Assumptions...........................................36 4 APPENDICES...................................................................................................................101 4.1 Appendix I: Date/Time Variables................................................................................101 4.2 Appendix II: Representing Results for Findings Domains.......................................104 4.3 Appendix III: Using the RELATES Table to Link Records........................................106 4.3.1 OVERVIEW.............................................................................................................106 4.3.2 --SEQ AND --SEQSP.............................................................................................106 4.3.3 RELATES TABLE..................................................................................................107 4.3.4 EXAMPLES............................................................................................................108

9. 9 Miscellaneous in translation Use English label, not Japanese Use English technical term, not Japanese These will be described in glossary

10. 10 ADaM group To understand ADaM standard ADaM guideline Change-from-Baseline Time-to-Event Categorical Current status First draft

11. 11 Comparison of ADaM and SDM Models

12. 12 Schedule 2004 Go to next step SDS Complete translation of the model and a related guidance in February Review SDS models in terms of implementation into Japan Prepare SDS manual ADaM Complete translation of ADaM standard Prepare ADaM manual