The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because they are tested separately in both tobacco "as-is" and dried tobacco (as indicated by PTSPEC and PTSPCCND). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.
STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the 2 PT dataset examples.
PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent/parameter when such methodology is too complex for the single PTMETHOD variable.
Shows the PTTEST of product moisture, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1). Product moisture is used in chemistry stability studies. For microbial stability studies, water activity should be used, not product moisture (see row 3).
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 PTSPCCND to show that the tobacco is "DRIED".
Rows 2-11:
Show the other analytes used in testing (i.e., pH, water activity, NNK, NNN, TSNA) using the PTTEST and PTTESTCD variables.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
STOCONID
PTSEQ
PTTESTCD
PTTEST
PTCAT
PTORRES
PTORRESU
PTLLOD
PTSTRESC
PTSTRESN
PTSTRESU
PTXFN
PTNAM
PTSPEC
PTSPCCND
PTLLOQ
PTREPNUM
PTDTC
PTTPT
PTTPTNUM
1
TOB07
PT
Smokeless01
Condition 1
1
PRODMST
Product Moisture
STABILITY STUDY
52.0
%
0.1
52.0
52.0
%
TLT07_V1
TPT LABCO
TOBACCO
0.12
1
02-01-2023
Week 0
1
2
TOB07
PT
Smokeless01
Condition 1
2
PH
pH
STABILITY STUDY
8.06
8.06
8.06
TL009_V1
TPT LABCO
TOBACCO
1
02-01-2023
Week 0
1
3
TOB07
PT
Smokeless01
Condition 1
3
H2OACT
Water Activity
STABILITY STUDY
0.86
0.01
0.86
0.86
TLPH01_V1
TPT LABCO
TOBACCO
0.05
1
02-01-2023
Week 0
1
4
TOB07
PT
Smokeless01
Condition 1
4
NNK
Nicotine-Derived Nitrosamine Ketone
STABILITY STUDY
1.0225
ug/g
0.01
1.0225
1.0225
ug/g
TL026_V12.2
TPT LABCO
TOBACCO
AS-IS
0.05
1
02-01-2023
Week 0
1
5
TOB07
PT
Smokeless01
Condition 1
5
NNK
Nicotine-Derived Nitrosamine Ketone
STABILITY STUDY
0.4908
ug/g
0.01
0.4908
0.4908
ug/g
TL026_V12.2
TPT LABCO
TOBACCO
DRIED
0.05
1
02-01-2023
Week 0
1
6
TOB07
PT
Smokeless01
Condition 1
6
NNN
N-Nitrosonornicotine
STABILITY STUDY
4.4633
ug/g
0.01
4.4633
4.4633
ug/g
TL026_V12.2
TPT LABCO
TOBACCO
AS-IS
0.05
1
02-01-2023
Week 0
1
7
TOB07
PT
Smokeless01
Condition 1
7
NNN
N-Nitrosonornicotine
STABILITY STUDY
2.1424
ug/g
0.01
2.1424
2.1424
ug/g
TL026_V12.2
TPT LABCO
TOBACCO
DRIED
0.05
1
02-01-2023
Week 0
1
10
TOB07
PT
Smokeless01
Condition 1
8
AEBPLCT
Aerobic Plate Count
STABILITY STUDY
154000
CFU/g
1
154000
154000
CFU/g
TLMB_V1.1
TPT LABCO
TOBACCO
1
1
02-01-2023
Week 0
1
11
TOB07
PT
Smokeless01
Condition 1
9
TYMC
Total Yeast and/or Mold Count
STABILITY STUDY
<10
CFU/g
1
<10
CFU/g
TLMB_V1.1
TPT LABCO
TOBACCO
1
1
02-01-2023
Week 0
1
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The second PT dataset shows testing for just 1 parameter (product moisture), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study.
Details of the storage conditions are represented in the ES dataset example that follows.
Rows 1-9:
Show the results of testing product moisture in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID).
Rows 10-18:
Show the results of testing product moisture in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID).
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
STOCONID
PTSEQ
PTTESTCD
PTTEST
PTORRES
PTORRESU
PTLLOD
PTSTRESC
PTSTRESN
PTSTRESU
PTXFN
PTNAM
PTSPEC
PTSPCCND
PTLLOQ
PTREPNUM
PTDTC
PTTPT
PTTPTNUM
1
TOB07
PT
Smokeless01
Condition 1
111
PRODMST
Product Moisture
51.93
%
0.1
51.93
51.93
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
02-01-2023
Week 0
1
2
TOB07
PT
Smokeless01
Condition 1
112
PRODMST
Product Moisture
51.96
%
0.1
51.96
51.96
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
02-01-2023
Week 0
1
3
TOB07
PT
Smokeless01
Condition 1
113
PRODMST
Product Moisture
51.98
%
0.1
51.98
51.98
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
02-01-2023
Week 0
1
4
TOB07
PT
Smokeless01
Condition 1
114
PRODMST
Product Moisture
51.75
%
0.1
51.75
51.75
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
03-29-2023
Week 8
2
5
TOB07
PT
Smokeless01
Condition 1
115
PRODMST
Product Moisture
51.75
%
0.1
51.75
51.75
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
03-29-2023
Week 8
2
6
TOB07
PT
Smokeless01
Condition 1
116
PRODMST
Product Moisture
51.67
%
0.1
51.67
51.67
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
03-29-2023
Week 8
2
7
TOB07
PT
Smokeless01
Condition 1
117
PRODMST
Product Moisture
52.05
%
0.1
52.05
52.05
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
07-19-2023
Week 24
3
8
TOB07
PT
Smokeless01
Condition 1
118
PRODMST
Product Moisture
52.68
%
0.1
52.68
52.68
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
07-19-2023
Week 24
3
9
TOB07
PT
Smokeless01
Condition 1
119
PRODMST
Product Moisture
52.21
%
0.1
52.21
52.21
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
07-19-2023
Week 24
3
10
TOB07
PT
Smokeless01
Condition 2
120
PRODMST
Product Moisture
51.93
%
0.1
51.93
51.93
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
02-01-2023
Week 0
1
11
TOB07
PT
Smokeless01
Condition 2
121
PRODMST
Product Moisture
51.96
%
0.1
51.96
51.96
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
02-01-2023
Week 0
1
12
TOB07
PT
Smokeless01
Condition 2
122
PRODMST
Product Moisture
51.98
%
0.1
51.98
51.98
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
02-01-2023
Week 0
1
13
TOB07
PT
Smokeless01
Condition 2
123
PRODMST
Product Moisture
51.80
%
0.1
51.80
51.80
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
03-29-2023
Week 8
2
14
TOB07
PT
Smokeless01
Condition 2
124
PRODMST
Product Moisture
51.77
%
0.1
51.77
51.77
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
03-29-2023
Week 8
2
15
TOB07
PT
Smokeless01
Condition 2
125
PRODMST
Product Moisture
51.84
%
0.1
51.84
51.84
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
03-29-2023
Week 8
2
16
TOB07
PT
Smokeless01
Condition 2
126
PRODMST
Product Moisture
52.18
%
0.1
52.18
52.18
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
1
07-19-2023
Week 24
3
17
TOB07
PT
Smokeless01
Condition 2
127
PRODMST
Product Moisture
52.21
%
0.1
52.21
52.21
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
2
07-19-2023
Week 24
3
18
TOB07
PT
Smokeless01
Condition 2
128
PRODMST
Product Moisture
51.87
%
0.1
51.87
51.87
%
TLT07_V1
TPT LABCO
TOBACCO
AS-IS
0.12
3
07-19-2023
Week 24
3
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The ES dataset shows both sets of storage conditions used across both of the PT dataset examples.