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SDS&ADaM sub-team

28 January 2004

Mineko FUJIMOTORieko ICHIHARAKazue TOMITAHiroaki MATSUDA

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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:

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ADaM central team mission

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

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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

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SDS&ADaM teamsSDS&ADaM teams

SDS translation

ADaM translation

SDS manual

IdentifyJapanese Requirements

1st step

INPUT to Central

2nd step

ADaM manual

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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 ADaM standard Dec 19 Started translation; domain models

Jan. 15, 2004 4th meeting

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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

Guidance

J ver

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Progress of translation

SDS model Table of Contents

1 INTRODUCTION ...................................................................................................................42 GENERAL STUDY DATA INFORMATION MODEL.............................................................63 CDISC SUBMISSION DATA DOMAIN MODELS...............................................................263.1 Standard Dataset Content/Attributes of Domains.......................................................263.2 Using the CDISC Domain Models in Regulatory Submissions..................................263.3 Conformance ..................................................................................................................273.4 Commenting on the V3 CDISC Submission Data Domain Models ............................273.5 Domain Metadata Models ..............................................................................................283.5.1 General Assumptions for All Domains .................................................................283.5.2 CDISC Submission Dataset Definition Metadata .................................................353.5.3 Domain Models and Domain-Specific Assumptions ...........................................364 APPENDICES ...................................................................................................................1014.1 Appendix I: Date/Time Variables ................................................................................1014.2 Appendix II: Representing Results for Findings Domains.......................................1044.3 Appendix III: Using the RELATES Table to Link Records........................................1064.3.1 OVERVIEW.............................................................................................................1064.3.2 --SEQ AND --SEQSP .............................................................................................1064.3.3 RELATES TABLE ..................................................................................................1074.3.4 EXAMPLES ............................................................................................................108

Microsoft Word Document

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Miscellaneous in translation

Use English label, not Japanese Use English technical term, not Japanese

These will be described in glossary

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ADaM group

To understand ADaM standard ADaM guideline Change-from-Baseline Time-to-Event Categorical

Current status First draft guideline

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Comparison of ADaM and SDM Models

ADaM SDMEnd-user FDA Statistical Reviewer FDA Clinical Reviewer

Primary Review Responsibities Efficacy Safety

See FDA Guidance for Industry documentshttp://www.fda.gov/cder/guidance/index.htmhttp://www.fda.gov/cder/guidance/2867fnl.pdfData File Structure Reflects analysis and reporting Reflects data collection

Data analytic Human friendly for gestalt review

Specific to statistical model Standardized

Data Types Primarily Numeric Primarily Alpha-text

Coded Variables Numeric codes for analysis Descriptive Text

Data ‘Flags’ Yes Limited

May include variables that do not exist in theCRT database

Representation of patient listings

May be heavily derived and transformed Some derived data included

Represents a view of the CRTdatabase

No Yes

Standard variable namingconventions

Yes Yes

CDISC standard data model Yes with possible additional attributes Yes

Derived data

Scope of review Data supporting Primary and importantSecondary study objectives

Style of Data

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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