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Tobacco Implementation Guide (TIG) v1.0
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Tobacco Implementation Guide Home
TIG examples
TIG Product Description examples
ADaM Example.Stability Study for Smokeless Tobacco Products
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Versions Compared
Old Version
30
changes.mady.by.user
Christine Connolly
Saved on
Oct 03, 2023
compared with
New Version
31
changes.mady.by.user
Christine Connolly
Saved on
Oct 03, 2023
Previous Change: Difference between versions 29 and 30
Next Change: Difference between versions 31 and 32
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Definexmltable
Level
Dataset
Purpose
Analysis
OID
ADPT
Name
ADPT
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADPT
Reference Data for Birthrate
ADAM OTHER
one record per product stability identifier per parameter qualifier per parameter per analysis timepoint
Analysis
PRODSTID, PARQUAL, PARAM, ATPT
adpt.xpt
NA
Definexmltable
Dataset
ADPT
Level
Variable
Purpose
Analysis
Name
ADPT
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
CDISC Notes
STUDYID
Study Identifier
Char
Req
PT.STUDYID
PRODSTID
Product Stability Identifier
Char
Req
Concatenate SPTOBID with STOCONID separated with '/'
SPTOBID
Applicant-Defined Tobacco Product ID
Char
Perm
PT.SPTOBID
STOCONID
Applicant-Defined Storage Conditions ID
Char
Perm
PT.STOCONID
PARQUAL
Parameter Qualifier
Char
Cond
Set to the item being tested
PARAM
Parameter
Char
Req
Set to the parameter being captured
PARAMCD
Parameter Code
Char
Req
Set to the parameter code associated with the parameter
AVAL
Analysis Value
Num
Req
Calculated statistic
ATPT
Analysis Timepoint
Char
Cond
PT.PTTPT
ATPTN
Analysis Timepoint (N)
Num
Cond
PT.PTTPTNUM
Overview
Content Tools
{"serverDuration": 98, "requestCorrelationId": "da6bc24a48a27ee5"}