ADaM sub-team

SDS&ADaM
sub-team
28 January 2004
Mineko FUJIMOTO
Rieko ICHIHARA
Kazue TOMITA
Hiroaki MATSUDA
1
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:

2
ADaM central team mission
 Provide
metadata models and
examples of analysis datasets
that are used to generate the
statistical results for a regulatory
submission.
3
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
4
SDS&ADaM teams
1st step
SDS
translation
2nd step
SDS manual
ADaM
translation
ADaM manual
Identify
Japanese Requirements
INPUT to Central
5
History of SDS&ADaM team




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Apr 8, 2003
 Apr 9
 Apr 10
Jun 10,2003
Jul 22, 2003
Sep 16, 2004
 Sep 26
 Oct 7
 Dec 19
Jan. 15, 2004
1st meeting; Kick off
Opened Mailing list
Started translation ; text parts
Released SDS ver.3.0 final version
2nd meeting; follow-up
3rd meeting
Started reviewing
Started translation ADaM standard
Started translation; domain models
4th meeting
6
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
7
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
8
Miscellaneous in translation

Use English label, not Japanese
Use English technical term, not Japanese

These will be described in glossary

9
ADaM group

To understand ADaM standard





ADaM guideline
Change-from-Baseline
Time-to-Event
Categorical
Current status

First draft
10
Comparison of
ADaM and SDM Models
ADaM
SDM
FDA Statistical Reviewer
FDA Clinical Reviewer
Efficacy
Safety
Data supporting Primary and important
Secondary study objectives
Reflects analysis and reporting
Data analytic
See FDA Guidance for Industry documents
Specific to statistical model
Standardized
Primarily Numeric
Primarily Alpha-text
Numeric codes for analysis
Descriptive Text
Data ‘Flags’
Yes
Limited
Derived data
May include variables that do not exist in the
CRT database
Representation of patient listings
May be heavily derived and transformed
Some derived data included
No
Yes
Yes
Yes
Yes with possible additional attributes
Yes
End-user
Primary Review Responsibities
Scope of review
Data File Structure
Style of Data
Data Types
Coded Variables
Represents a view of the CRT
database
Standard variable naming
conventions
CDISC standard data model
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/cder/guidance/2867fnl.pdf
Reflects data collection
Human friendly for gestalt review
11
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
12

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