SDS&ADaM sub-team

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

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

6. History of SDS&ADaM team • Apr 8, 2003 1st meeting; Kick off • Apr 9 Opened Mailing list • Apr 10 Started translation ; text parts • Jun 10,2003 Released SDS ver.3.0 final version • Jul 22, 2003 2nd meeting; follow-up • Sep 16, 2004 3rd meeting • Sep 26 Started reviewing • Oct 7 Started translation ADaMstandard • Dec 19 Started translation; domain models • Jan. 15, 2004 4th meeting

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

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

11. Comparison of ADaM and SDM Models

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