This example will need to be updated following the ENDS stability study approach, which was created to reflect recent developments and consultation with CDISC ISMT
NOTE TO TEAM REVIEWERS:
The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study. The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study.
For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows:
First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated.
Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like.
Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group.
Tobacco domains
DI = TO for Tobacco Product Identifiers and Descriptors
SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier
Shelf life study has a protocol and provides the results of shelf life studies of tobacco products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc.
The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for tobacco products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.
Row 1:
Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in PTTSTCND which is Condition 1 (X°C/ Z% RH). Product Moisture is sometimes referred to as "Oven Volatiles".
Rows 4, 6, 8:
Show the NNK, NNN, and TSN tests with the tobacco product "as-is" using the PTSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9:
Show the NNK, NNN, and TSN tests with the tobacco product as "Dry weight basis (DWB)" using the TTSPCCND to show that the tobacco is "DRIED".
Rows 2-12:
Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables.
*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only moisture content using the TEST of Product Moisture (also known as Oven Volatile) percentage is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes.
Rows 1-9:
Show the PTTEST of Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-18:
Show the PTTEST of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The PTGRPID is used to tie together a block of related records in a single domain.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
STOCONID
PTSEQ
PTREFID
PTTESTCD
PTTEST
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTSPCCND
PTMETHOD
PTREPNUM
PTTPT
PTTPTNUM
1
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
111
TOB77777.1
PRODMST
Product Moisture
51.93
%
51.93
51.93
%
TOBACCO
1
Week 0
1
2
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
112
TOB77777.1
PRODMST
Product Moisture
51.96
%
51.96
51.96
%
TOBACCO
2
Week 0
1
3
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
113
TOB77777.1
PRODMST
Product Moisture
51.98
%
51.98
51.98
%
TOBACCO
3
Week 0
1
4
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
114
TOB77777.1
PRODMST
Product Moisture
51.75
%
51.75
51.75
%
TOBACCO
1
Week 8
4
5
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
115
TOB77777.1
PRODMST
Product Moisture
51.75
%
51.75
51.75
%
TOBACCO
2
Week 8
4
6
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
116
TOB77777.1
PRODMST
Product Moisture
51.67
%
51.67
51.67
%
TOBACCO
3
Week 8
4
7
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
117
TOB77777.1
PRODMST
Product Moisture
52.05
%
52.05
52.05
%
TOBACCO
1
Week 48
9
8
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
118
TOB77777.1
PRODMST
Product Moisture
52.68
%
52.68
52.68
%
TOBACCO
2
Week 48
9
9
TOB07
PT
Smokeless01
Condition 1 (X°C/ Z% RH)
119
TOB77777.1
PRODMST
Product Moisture
52.21
%
52.21
52.21
%
TOBACCO
3
Week 48
9
10
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
120
TOB77777.1
PRODMST
Product Moisture
51.93
%
51.93
51.93
%
TOBACCO
1
Week 0
1
11
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
121
TOB77777.1
PRODMST
Product Moisture
51.96
%
51.96
51.96
%
TOBACCO
2
Week 0
1
12
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
122
TOB77777.1
PRODMST
Product Moisture
51.98
%
51.98
51.98
%
TOBACCO
3
Week 0
1
13
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
123
TOB77777.1
PRODMST
Product Moisture
51.80
%
51.80
51.80
%
TOBACCO
1
Week 8
4
14
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
124
TOB77777.1
PRODMST
Product Moisture
51.77
%
51.77
51.77
%
TOBACCO
2
Week 8
4
15
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
125
TOB77777.1
PRODMST
Product Moisture
51.84
%
51.84
51.84
%
TOBACCO
3
Week 8
4
16
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
126
TOB77777.1
PRODMST
Product Moisture
52.18
%
52.18
52.18
%
TOBACCO
1
Week 48
9
17
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
127
TOB77777.1
PRODMST
Product Moisture
52.21
%
52.21
52.21
%
TOBACCO
2
Week 48
9
18
TOB07
PT
Smokeless01
Condition 2 (A °C/ B %RH)
128
TOB77777.1
PRODMST
Product Moisture
51.87
%
51.87
51.87
%
TOBACCO
3
Week 48
9
Dataset Debug Message
Please remove extraneous empty columns.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
From previous page: - update for this example.... values are likely different - ??? - Condition 1 and Condition 2
The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.
The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above. (We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)