NOTE: THIS SECTION MAY CHANGE . DEVICE DOMAIN MAY BE USED TO REPRESENT THE SMOKING MACHINE PARAMETERS
Fix MATRIX variable
Tobacco product stability study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. The details of the regimen and storage conditions are shown in separate datasets that follow this example.
The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.
The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product.
This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset. These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.
Rows 1-15:
Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND.
Row 16:
Shows the HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
SPDEVID
PTSEQ
PTREFID
PTTESTCD
PTTEST
PTCAT
PTSCAT
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTSPEC
PTMETHOD
PTREPNUM
PTTPT
PTTPTNUM
PTDTC
1
TOB07
PT
CIG01a
1
Sample 1
ACETALD
Acetaldehyde
HPHC TESTING
HPHC
1639
ug/cigarette
1639
1639
ug/cigarette
SMOKE
ISO INTENSE METHOD
1
Week 0
1
2022-09-30
2
TOB07
PT
CIG01a
2
Sample 1
ACROL
Acrolein
HPHC TESTING
HPHC
154
ug/cigarette
154
154
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
3
TOB07
PT
CIG01a
3
Sample 1
ACRLONI
Acrylonitrile
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
4
TOB07
PT
CIG01a
4
Sample 1
AMNPHEN4
4-Aminobiphenyl
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
5
TOB07
PT
CIG01a
5
Sample 1
AMNPHTH1
1-Aminonaphthalene
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
6
TOB07
PT
CIG01a
6
Sample 1
NH4
Ammonia
HPHC TESTING
HPHC
29.2
ug/cigarette
29.2
29.2
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
7
TOB07
PT
CIG01a
7
Sample 1
BENZ
Benzene
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
8
TOB07
PT
CIG01a
8
Sample 1
BENZAP
Benzo[a]pyrene
HPHC TESTING
HPHC
30.5
ug/cigarette
30.5
30.5
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
9
TOB07
PT
CIG01a
9
Sample 1
CO
Carbon monoxide
HPHC TESTING
HPHC
28.2
ug/cigarette
28.2
28.2
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
10
TOB07
PT
CIG01a
10
Sample 1
CROTALD
Crotonaldehyde
HPHC TESTING
HPHC
0.01
0.01
0.01
ISO INTENSE METHOD
1
2022-09-30
11
TOB07
PT
CIG01a
11
Sample 1
FORMALD
Formaldehyde
HPHC TESTING
HPHC
83.2
ug/cigarette
83.2
83.2
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
12
TOB07
PT
CIG01a
12
Sample 1
ISOPRN
Isoprene
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
13
TOB07
PT
CIG01a
13
Sample 1
NIC
Nicotine
HPHC TESTING
HPHC
1.71
ug/cigarette
1.71
1.71
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
14
TOB07
PT
CIG01a
14
Sample 1
NNK
Nicotine-derived Nitrosamine Ketone
HPHC TESTING
HPHC
ISO INTENSE METHOD
1
2022-09-30
15
TOB07
PT
CIG01a
15
Sample 1
NNN
N-nitrosonornicotine
HPHC TESTING
HPHC
284
ug/cigarette
284
284
ug/cigarette
ISO INTENSE METHOD
1
2022-09-30
16
TOB07
PT
CIG01a
16
Sample 1
ACETALD
Acetaldehyde
HPHC TESTING
HPHC
1569
ug/cigarette
1569
1569
ug/cigarette
CANADIAN INTENSE METHOD
1
2022-09-30
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Environmental Storage Conditions (ES) dataset can be used to provide additional details on any test conditions or methods used to perform the testing.
es.xpt
es.xpt
Row
STUDYID
DOMAIN
STOCONID
ESSEQ
ESPARMCD
ESPARM
ESVAL
ESVALU
1
TOB07
ES
Condition 1
1
ISOSTNUM
ISO Standard Number
ISO 3308
2
TOB07
ES
Condition 1
2
PUFFVOL
Puff Duration
PT2S
3
TOB07
ES
Condition 1
3
PUFFVOL
Puff Volume
35
mg
4
TOB07
ES
Condition 2
1
PUFFDUR
Puff Duration
PT2S
5
TOB07
ES
Condition 2
2
SMOKMAC
Smoking Machine
Big
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Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).
di.xpt
di.xpt
Row
STUDYID
DOMAIN
SPDEVID
DISEQ
DIPARMCD
DIPARM
DIVAL
1
TOB07
DI
PUFFMASTER3K
1
DEVTYPE
Device Type
Smoking Machine
2
TOB07
DI
PUFFMASTER3K
2
MANUF
Manufacturer
Acme
3
TOB07
DI
PUFFMASTER3K
3
TRADENAM
Trade Name
PuffMaster 3000
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Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
du.xpt
du.xpt
Row
STUDYID
DOMAIN
SPDEVID
DUSEQ
DUREFID
DUGRPID
DUTESTCD
DUTEST
DUORRES
DUORRESU
DUSTRESC
DUSTRESN
DUSTRESU
1
TOB07
DU
PUFFMASTER3K
1
Medium Intensity Regimen
PUFFPROF
Puff Profile
SQUARE
SQUARE
2
TOB07
DU
PUFFMASTER3K
2
Medium Intensity Regimen
PUFFDUR
Puff Duration
1.25
sec
1.25
1.25
sec
3
TOB07
DU
PUFFMASTER3K
3
Medium Intensity Regimen
PUFFINT
Puff Interval
3
PUFF/min
3
3
PUFF/min
4
TOB07
DU
PUFFMASTER3K
4
Medium Intensity Regimen
PUFFBLCK
Puff Block
25
%
25
25
%
5
TOB07
DU
PUFFMASTER3K
5
Medium Intensity Regimen
NUMPUFF
Total Number of Puffs
200
PUFF
200
200
PUFF
6
TOB07
DU
PUFFMASTER3K
6
Medium Intensity Regimen
PUFFVOL
Puff Volume
10
mL
10
10
mL
7
TOB07
DU
PUFFMASTER3K
7
Medium Intensity Regimen
PUFFRNG
Puff Range
100-200
100-200
8
TOB07
DU
PUFFMASTER3K
8
Medium Intensity Regimen
1
PUFFPAUS
Puff Pause
60
s
60
60
s
9
TOB07
DU
PUFFMASTER3K
9
Medium Intensity Regimen
1
PUFFPINT
Puff Pause Interval
10
PUFF
10
10
PUFF
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Finally, we assume we still need to parse out storage conditions of "E-Liquid Standard (Long Term) Condition".Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.
The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
These values were made up, but we assume they'd look something like this.